A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)

Body Weight

Time Frame: Baseline to Week 40 or endpoint

Weight change from baseline

Extrapyramidal Symptoms [EPS]

Time Frame: Week 40 or endpoint

EPS was assessed using the (1) involuntary movement scale \[AIMS\], (2) Barnes Akathisia Rating Scale \[BARS\], and (3) Simpson Angus Rating Scale SARS. AIMS score range 0-4; higher scores indicate greater symptom severity. BARS score rang 0-9; higher scores indicate greater severity of akathisia. SARS score range 0-40; higher scores indicate greater degree of Parkinsonism.

Number of Participants With Abnormal Electrocardiogram

Time Frame: Week 40 or endpoint

This is the number of participants with electrocardiogram (ECG) adverse events.

Number of Participants With Laboratory Values Outside Normal Range

Time Frame: Week 40 or endpoint

Normal ranges were provided by the central laboratory. Biochemistry = electrolytes, creatine kinase, liver enzymes, blood urea nitrogen, creatinine, alkaline phosphatase, protein, albumin Metabolic chemistry = cholesterol, glucose, triglycerides, glycosylated hemoglobin Endocrinology/miscellaneous = insulin, prolactin Hematology = hemoglobin, red blood cell count, white blood cell count, platelets, hematocrit, neutrophils, lymphocytes, monocytes, eosinophils, basophils

Participants Who Experienced Adverse Event(s)

Time Frame: Up to 40 weeks

Adverse event (AE) data, both serious and non-serious, were collected. Serious AEs were also collected up to 30 days post last dose of study drug. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An AE is defined as serious if it results in death, is life-threatening, requires in-patient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Number of Participants With Abnormal Physical Examination Findings

Time Frame: Week 40 or endpoint

Physical exam (PE) included assessment of general appearance, skin, head, eyes, ears, nose, throat, lungs, blood pressure, cardiac rhythm \& rate, neurologic status, and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.

Abdominal Girth

Time Frame: Baseline to Week 40 or endpoint

Change in abdominal girth from baseline

Concomitant Medications

Time Frame: Up to 40 weeks

Concomitant medications are any medications taken on or after the date of first dose of double-blind study drug through the date of last dose of double-blind study drug.

Number of Participants With Markedly Abnormal Vital Sign Changes

Time Frame: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)

Vital signs measured: sitting blood pressure, heart rate. Definitions: Markedly abnormal decreases: heart rate (HR) - if ≤50 bpm and decrease from baseline of ≥15 beats per minute (bpm); systolic blood pressure (SBP) - if ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure (DBP) - if ≤50 mm Hg and decrease from baseline of ≥15 mm Hg. Markedly abnormal increases: HR - if ≥110 bpm and increase from baseline of ≥15 bpm; SBP - if ≥180 mm Hg and increase from baseline of ≥20 mm Hg; DBP - if ≥105 mm Hg and increase from baseline of ≥15 mm Hg.