Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.