40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

Primary outcomes

1. 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.

2. 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.

3. Number of Participants With Abnormal Electrocardiogram

   Time frame: Week 40 or endpoint

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

4. Body Weight

   Time frame: Baseline to Week 40 or endpoint

   Weight change from baseline

5. 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.

6. 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.

7. Abdominal Girth

   Time frame: Baseline to Week 40 or endpoint

   Change in abdominal girth from baseline

8. 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.

9. 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