| Primary | Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death | A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death. | In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period. | Posted | | Number | | Percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
| | | Title | Denominators | Categories |
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| Participants with TEAEs | | | | Participants with serious TEAEs | | | | Participants with severe TEAEs | | |
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| Secondary | Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS) | Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25. | In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS) | The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia. | In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS) | EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms. | In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS) | The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated. | In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Body Temperature From Baseline in All Participants. | The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | °C | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Heart Rate Supine From Baseline in All Participants. | The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | beats/min | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants. | The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Diastolic Supine BP From Baseline in All Participants. | The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Heart Rate From Baseline in All Participants. | The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | beats/min | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Systolic BP From Baseline in All Participants. | The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Diastolic BP From Baseline in All Participants. | The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | mmHg | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Ventricular Rate From Baseline in All Participants. | The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | Beats/min | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in PR Interval From Baseline in All Participants. | The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | msec | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in RR Interval From Baseline in All Participants. | The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | msec | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in QRS Interval From Baseline in All Participants. | The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | msec | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in QT Interval From Baseline in All Participants. | The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | msec | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in QTcB Interval From Baseline in All Participants. | The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | msec | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in QTcF Interval From Baseline in All Participants. | The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | msec | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in QTcN Interval From Baseline in All Participants. | The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria. | Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | msec | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants. | Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. | Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | Kg | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants. | Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. | Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). | Posted | | Mean | Standard Deviation | Kg/m2 | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants. | Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss. | Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). Only Week 24 and last visit data was included. | Posted | | Mean | Standard Deviation | cm | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Number of Participants With Clinically Relevant Laboratory Values. | The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. | All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). There were no clinically relevant findings with regard to laboratory values reported in this study. | Posted | | Number | | participants | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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| Secondary | Number of Participants With Clinically Relevant Physical Examination. | The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae. | All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). None of the abnormalities or findings were noted during physical examination were considered clinically relevant. | Posted | | Number | | participants | | Baseline to last visit | | | | ID | Title | Description |
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| OG000 | Aripiprazole IM Depot 400/ 300 mg | All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks. |
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