A Trial of Multiple-doses of Aripiprazole in Adults With... | NCT04030143

Label	Type	Description	Intervention Names
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Experimental	Participants with schizophrenia or bipolar I disorder received aripiprazole 2 month (2M) long-acting injection (LAI) 960 milligrams (mg) for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Drug: Aripiprazole
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Experimental	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.	Drug: Aripiprazole

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole	Drug	Administered as an intramuscular (IM) depot injection.	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder

Measure	Description	Time Frame
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)	An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that started after investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of the IMP.	From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Potentially clinically significant vital sign abnormalities included: heart rate supine (high: >120 beats per minute [BPM] and increase >=15 BPM; low: <50 BPM and decrease >=15 BPM), systolic blood pressure supine (high >180 (millimetres of mercury [mmHg] and increase >=20 mmHg); low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure supine (high: >105 mmHg and increase >=15 mmHg; low: <50 mmHg and decrease >=15 mmHg), heart rate standing (high: >120 BPM and increase >=15 BPM), systolic blood pressure standing (high: >180 mmHg and increase >= 20 mmHg; low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure standing (high: >105 mmHg and increase >=15 mmHg), weight in kilograms (kg) (high: increase >=7%; low: decrease >=7%), temperature (high: >=37.8 degree celsius [°C] and increase >=1.1°C), orthostatic hypotension (low: >=20 mmHg decrease in systolic blood pressure and >=25 BPM increase in heart rate from supine to standing.	From first dose of study drug up to Day 225
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Potentially clinically significant ECG abnormalities included rate: bradycardia (vent <=50 BPM] and decrease >=15 BPM); rhythm: sinus bradycardia (<= 50 BPM and decrease >= 15 BPM and no current diagnosis of atrial fibrillation, atrial flutter, or other rhythm abnormality); supraventricular premature beat (not present at baseline and present post baseline); ventricular premature beat (not present at baseline and present post baseline); conduction: right bundle branch block (not present at baseline and present post baseline); ST/T morphology: myocardial ischemia and symmetrical T-wave inversion (not present at baseline and present post baseline), QTcB, QTcF, and QTcN (>=450 milliseconds [msec] and >= 10% increase).

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg		Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225

Facility	Status	City	State	ZIP	Country	Contacts
Woodland International Research Group		Little Rock	Arkansas	72211	United States
Woodland International Research Group

PubMed Identifier	Type	Citation	Retractions
37672016	Derived	Citrome L, Such P, Yildirim M, Madera-McDonough J, Beckham C, Zhang Z, Larsen F, Harlin M. Safety and Efficacy of Aripiprazole 2-Month Ready-to-Use 960 mg: Secondary Analysis of Outcomes in Adult Patients With Schizophrenia in a Randomized, Open-label, Parallel-Arm, Pivotal Study. J Clin Psychiatry. 2023 Sep 4;84(5):23m14873. doi: 10.4088/JCP.23m14873.
37272079

ID	Title	Description
FG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2 month (2M) long-acting injection (LAI) 960 milligrams (mg) for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 31, 2019	Sep 21, 2023

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

Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that started after investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of the IMP.

Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.

Posted

Count of Participants

Participants

From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000132 OG001134

Title

Denominators

Categories

Title	Measurements
	OG00094 OG00195

Primary

Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities

Potentially clinically significant vital sign abnormalities included: heart rate supine (high: >120 beats per minute [BPM] and increase >=15 BPM; low: <50 BPM and decrease >=15 BPM), systolic blood pressure supine (high >180 (millimetres of mercury [mmHg] and increase >=20 mmHg); low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure supine (high: >105 mmHg and increase >=15 mmHg; low: <50 mmHg and decrease >=15 mmHg), heart rate standing (high: >120 BPM and increase >=15 BPM), systolic blood pressure standing (high: >180 mmHg and increase >= 20 mmHg; low: <90 mmHg and decrease >=20 mmHg), diastolic blood pressure standing (high: >105 mmHg and increase >=15 mmHg), weight in kilograms (kg) (high: increase >=7%; low: decrease >=7%), temperature (high: >=37.8 degree celsius [°C] and increase >=1.1°C), orthostatic hypotension (low: >=20 mmHg decrease in systolic blood pressure and >=25 BPM increase in heart rate from supine to standing.

Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with data available for analysis of specified parameter.

Posted

Count of Participants

Participants

From first dose of study drug up to Day 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Primary

Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities

Potentially clinically significant ECG abnormalities included rate: bradycardia (vent <=50 BPM] and decrease >=15 BPM); rhythm: sinus bradycardia (<= 50 BPM and decrease >= 15 BPM and no current diagnosis of atrial fibrillation, atrial flutter, or other rhythm abnormality); supraventricular premature beat (not present at baseline and present post baseline); ventricular premature beat (not present at baseline and present post baseline); conduction: right bundle branch block (not present at baseline and present post baseline); ST/T morphology: myocardial ischemia and symmetrical T-wave inversion (not present at baseline and present post baseline), QTcB, QTcF, and QTcN (>=450 milliseconds [msec] and >= 10% increase).

Posted

Count of Participants

Participants

From first dose of study drug up to Day 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder

Primary

Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities

Potentially clinically relevant laboratory abnormalities included: In units per liter [U/L] (alanine aminotransferase: male[M]/female[F] >=3 x upper limit of normal (ULN); aspartate aminotransferase: M/F >= 3 x ULN; creatine kinase: M/F >= 3 x ULN); in milligrams per deciliter (mg/dL) (creatinine: M/F >= 2.0; glucose: M/F >= 200; urate: M >=10.5, F >=8.5); potassium [milliequivalents per liter (mEq/L)]: M/F >=5.5, in percentage (%) (eosinophils/leukocytes: M/F>=10%, hematocrit: M<=37%/F<=32% and 3 point decrease from baseline); hemoglobin (grams per deciliter [g/dL]): M<=11.5/F<=9.5; leukocytes [10^9 per liter (/L)]: M/F<=2.8 x 10^3 per microliters (/uL); platelets (10^9/L): M/F>=700 x 10^3/uL; glucose, urine and protein, urine: increase of >=2 units; and prolactin (nanograms per milliliter [ng/mL]: M/F > 1 x ULN.

Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with data available for analysis of specified parameter.

Posted

Count of Participants

Participants

From first dose of study drug up to Day 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Primary

Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score

The SAS scale is used to evaluate extrapyramidal symptoms (EPS) and consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of range of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores for all 10 items, possible total score is 0 to 40. Negative change from baseline indicates less symptoms.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Primary

Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score

The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7), dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, aware/severe distress). AIMS movement score is the sum of the ratings for the first seven items with the possible total scores of 0 to 28. Negative change from baseline indicates less symptoms.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Primary

Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score

The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia. Total BARS score ranges from 0 to 14 where lower scores indicate less symptoms and negative change from baseline indicate less symptoms.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Primary

Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg

Injection-site pain was evaluated by mean VAS scores as reported by the participant after each injection at visits where an injection occurred. The last injection was the final injection for any given participant. Ratings ranged from 0 (no pain) to 100 (unbearably painful).

Posted

Mean

Standard Deviation

score on a scale

Day 1 (First injection) to Day 169 (Last injection)

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Primary

VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg

Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. Participants whose VAS scores were analyzed for pain perception, are reported in this outcome measure, and may differ from participants who were assessed by Investigator for pain on 4-point scale.

Posted

Mean

Standard Deviation

score on a scale

Day 1 (First injection) to Day 197 (Last injection)

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants

Primary

Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection

Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe). The participant indicated the degree of pain at the most recent injection site using a VAS instrument. Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The last injection was the final injection for any given participant.

Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.

Posted

Count of Participants

Participants

Day 1 (First injection) to Day 169 (Last injection)

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts

Primary

Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection

Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. Participants whose injection-site reactions were assessed by the investigator, are reported in this outcome measure, and may differ from participants whose VAS scores were assessed for pain.

Posted

Count of Participants

Participants

Day 1 (First injection) to Day 197 (Last injection)

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Primary

Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

C-SSRS was used to assess the suicidality of participants during the study. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior. Suicidality was defined as reporting any suicidal ideation or behavior.

Posted

Count of Participants

Participants

Baseline to Day 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001

Primary

Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose

Pharmacokinetics (PK) sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure (OM) analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Posted

Mean

Standard Deviation

ng/mL (nanogram per milliliter)

Day 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Primary

Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose

PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Posted

Mean

Standard Deviation

ng/mL

Day 225

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Primary

Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of Aripiprazole After the Seventh and Eighth Doses of Aripiprazole IM Depot 400 mg

PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Posted

Mean

Standard Deviation

day*ng/mL

Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197 (predose and 4, 8, 12 hours post dose), 198, 199, 201, 204, 206, 209, 211, 214, 218, 225

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Primary

Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) of Aripiprazole After the Fourth Dose of Aripiprazole 2M LAI 960 mg

Posted

Mean

Standard Deviation

day*ng/mL

Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Posted

Mean

Standard Deviation

ng/mL

Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

Posted

Median

Full Range

days

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg

PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Posted

Mean

Standard Deviation

day*ng/mL

Days 1 (predose and 4, 8, 12 hours post-dose), 2, 3, 5, 8, 10, 13, 15, 18, 22, 29, 36, 43, 50 and 57 (pre-dose)

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg

PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Posted

Mean

Standard Deviation

ng/mL

Predose on Day 57

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg

PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Posted

Mean

Standard Deviation

day*ng/mL

Days 169 (predose and 4, 8, 12 hours postdose), 170, 171, 173, 176, 178, 181, 183, 186, 190, and 197

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Area Under the Plasma Concentration-Time Curve From Time 29 to 56 Days (AUC29-56) After the Fourth Dose of Aripiprazole 2M LAI 960 mg

PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Posted

Mean

Standard Deviation

day*ng/mL

Days 204, 211, 218, and 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg

PTF% was determined as 100*(Cmax - Cmin [minimum plasma concentration of the drug])/Caverage (average steady-state plasma drug concentration during multiple-dose administration) following fourth dose.

PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Posted

Mean

Standard Deviation

percentage fluctuation

Days 169 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants

Secondary

Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Posted

Mean

Standard Deviation

ng/mL

Predose [within 2 hours prior to dosing; 4,8,12h postdose] on Days 1,169,197; Predose on Days 29,57,85,113,141; and on Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 170, 171, 173, 176, 178, 181, 183, 186, 190,198, 199, 201, 204, 206, 209, 211, 214, 218, 225

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Posted

Median

Full Range

days

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg

Posted

Mean

Standard Deviation

day*ng/mL

Days 1 (predose and 4, 8, and 12 hours postdose), 2, 3, 5, 8, 10, 13, 15, 18, 22 and 29 (predose)

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg

Posted

Mean

Standard Deviation

ng/mL

Predose on Day 29

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg

Posted

Mean

Standard Deviation

percentage fluctuation

Days 197 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose),198, 199, 201, 204, 206, 209, 211, 214, 218, 225

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg

PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Posted

Mean

Standard Deviation

ng/mL

Day 8

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg

PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Posted

Mean

Standard Deviation

ng/mL

Day 15

ID	Title	Description
OG000	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worse condition. The PANSS was assessed for schizophrenia participants only.

Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia	Participants with schizophrenia received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Schizophrenia	Participants with schizophrenia received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Secondary

Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score

The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The cumulative score range is 0-7. A higher score on the CGI-S represents a higher severity of disease. The CGI-S scale was assessed for schizophrenia participants only.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia	Participants with schizophrenia received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Schizophrenia	Participants with schizophrenia received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Secondary

Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score

The CGI-I scale is a clinician rated scale which assesses the improvement of illness for each participant. To assess CGI-I, the rater or investigator rated the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared with the participant's condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Scores range from 0 to 7. Higher scores indicate worse condition.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Secondary

Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score

The participant's feeling of their own well-being was assessed using the 20-question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of well-being while receiving antipsychotic medication. The questionnaire consisted of 20 items (10 positive and 10 negative statements) and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', the response choices and scoring is not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, and very much = 6. For items marked with a '- ', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 1 (none) to 6 (severe), and total score ranged from 20 to 120, with higher scores indicating stronger subjective feeling

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Secondary

Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a diagnostic questionnaire used by clinician to assess the participant's severity of depression. This scale consists of 10 items each with 7 defined grades of severity on 0 to 6 scale (reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). MADRS total score is sum of 10 individual item scores ranging from 0-60 categorized as: 0 to 6: normal/symptoms absent, 7 to 19: mild depression, 20 to 34: moderate depression, and 35 to 60: severe depression. Higher score indicates more depressive symptoms. The MADRS was assessed for bipolar I disorder participants only.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Bipolar I Disorder	Participants with bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Bipolar I Disorder	Participants with bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Secondary

Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score

The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to assess the core symptoms of mania and is based on the participants subjective report of their condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score is summed of 11 items. Total score range is from 0 to 60 and the higher score represent a worse outcome. The YMRS was assessed for bipolar I disorder participants only.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Bipolar I Disorder	Participants with bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Bipolar I Disorder	Participants with bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Secondary

Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score

The CGI-BP scale refers to the global impression of the participants with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and change from preceding phase (CGI-BP change from preceding phase: mania, depression, and overall bipolar illness) based on a 7-point scale ranging from 1 (normal, not ill) to 7 (very severely ill). A negative change score signifies improvement. The CGI-BP was assessed for bipolar I disorder participants only.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 32

ID	Title	Description
OG000	Aripiprazole 2M LAI 960 mg: Bipolar I Disorder	Participants with bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
OG001	Aripiprazole IM Depot 400 mg: Bipolar I Disorder	Participants with bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Photophobia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Vision Blurred	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0012 affected134 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0015 affected134 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 affected132 at risk EG0018 affected134 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Dental Discomfort	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected132 at risk EG0011 affected134 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0013 affected134 at risk
Flatulence	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0012 affected134 at risk
Gingival Swelling	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 affected132 at risk EG0011 affected134 at risk
Salivary Hypersecretion	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected134 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG00110 affected134 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0011 affected134 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Influenza Like Illness	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0012 affected134 at risk
Injection Site Discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Injection Site Mass	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Injection Site Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG00024 affected132 at risk EG00112 affected134 at risk
Oedema Peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Bacterial Vaginosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Body Tinea	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected134 at risk
Infected Bite	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Localised Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0014 affected134 at risk
Periodontitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Pustule	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0012 affected134 at risk
Tooth Abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0006 affected132 at risk EG0012 affected134 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0013 affected134 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Burns First Degree	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0012 affected134 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Nail Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0012 affected134 at risk
Blood Pressure Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0012 affected134 at risk
Blood Prolactin Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Blood Triglycerides Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Body Temperature Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Electrocardiogram T Wave Inversion	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Heart Rate Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Hepatic Enzyme Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Liver Function Test Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Weight Decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0013 affected134 at risk
Weight Increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00030 affected132 at risk EG00128 affected134 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected134 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Increased Appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0012 affected134 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0011 affected134 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected132 at risk EG0014 affected134 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0010 affected134 at risk
Muscle Twitching	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0010 affected134 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Akathisia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00013 affected132 at risk EG00112 affected134 at risk
Bradykinesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Disturbance In Attention	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected134 at risk
Dyskinesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0004 affected132 at risk EG0012 affected134 at risk
Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Extrapyramidal Disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected134 at risk
Head Titubation	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00010 affected132 at risk EG0015 affected134 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Intention Tremor	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Loss of Consciousness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Oromandibular Dystonia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Parkinsonism	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Sciatica	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Sedation	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Somnolence	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0006 affected132 at risk EG0014 affected134 at risk
Tension Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Tremor	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0014 affected134 at risk
Agitation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00011 affected132 at risk EG00110 affected134 at risk
Bipolar Disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Bruxism	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Depressed Mood	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Depressive Symptom	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected134 at risk
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00010 affected132 at risk EG00111 affected134 at risk
Libido Decreased	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Psychotic Symptom	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Restlessness	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0003 affected132 at risk EG0010 affected134 at risk
Schizophrenia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0005 affected132 at risk EG0011 affected134 at risk
Suicidal Ideation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Polyuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0012 affected134 at risk
Vulvovaginal Pruritus	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0011 affected134 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0012 affected134 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0012 affected134 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Skin Fissures	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0016 affected134 at risk

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.
BG001	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	1	132	6	132	92	132
EG001	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.	0	134	8	134	92	134

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac Arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0010 affected134 at risk
Septic Shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Adenocarcinoma of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Akathisia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Depressive Symptom	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected132 at risk EG0010 affected134 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected132 at risk EG0011 affected134 at risk
Schizophrenia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 affected132 at risk EG0011 affected134 at risk