Table 2.
Summary of AEs and common TEAEs (ATS)
| Summary of AEs | PBO/ASN 2.5 mg BID, n=31 n (%) |
ASN 2.5 mg BID/ASN 2.5 mg BID, n=31 n (%) |
ASN 5 mg BID/ASN 5 mg BID, n=42 n (%) | OLZ 15 mg QD/OLZ 15 mg QD, n=16 n (%) |
|---|---|---|---|---|
| Patients with | ||||
| ≥1 SAEs | 5 (16.1) | 2 (6.5) | 6 (14.3) | 2 (12.5) |
| ≥1 AEs | 23 (74.2) | 13 (41.9) | 18 (42.9) | 6 (37.5) |
| ≥1 TEAEs | 22 (71.0) | 12 (38.7) | 16 (38.1) | 4 (25.0) |
| ≥1 AEs leading to treatment discontinuation | 5 (16.1) | 1 (3.2) | 7 (16.7) | 3 (18.8) |
| ≥1 treatment-related TEAEs | 11 (35.5) | 4 (12.9) | 7 (16.7) | 2 (12.5) |
| ≥1 treatment-related TEAEs leading to treatment discontinuation | 1 (3.2) | 0 (0.0) | 3 (7.1) | 1 (6.3) |
| Patients with TEAEs (≥5% in any treatment group) | ||||
| Psychiatric disorder | ||||
| Schizophrenia | 2 (6.5) | 2 (6.5) | 5 (11.9) | 1 (6.3) |
| Insomnia | 2 (6.5) | 2 (6.5) | 2 (4.8) | 0 (0.0) |
| Schizophrenia, paranoid type | 2 (6.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Suicide attempt | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.3) |
| Nervous system disorders | ||||
| Somnolence | 2 (6.5) | 1 (3.2) | 1 (2.4) | 0 (0.0) |
| Akathisia | 2 (6.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Dyskinesia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.3) |
| Infections and infestations | ||||
| Nasopharyngitis | 1 (3.2) | 0 (0.0) | 1 (2.4) | 1 (6.3) |
| Pulmonary tuberculosis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.3) |
| Urinary tract infection | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.3) |
| Investigations | ||||
| Weight increased | 3 (9.7) | 1 (3.2) | 1 (2.4) | 0 (0.0) |
| Blood creatine phosphokinase increased | 2 (6.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Blood insulin increased | 2 (6.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Injury, poisoning, and procedural complications | ||||
| Accidental overdose | 1 (3.2) | 1 (3.2) | 3 (7.1) | 0 (0.0) |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Bronchitis, chronic | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.3) |
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (6.3) |
| Vascular disorders | ||||
| Hypertension | 2 (6.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Notes: AEs were coded using MedDRA version 17.1. An AE was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with any use of a study drug, whether or not it was considered related to use; a TEAE was a newly reported event after acute study baseline, or an event reported to have worsened in severity since acute study baseline (period for determination of TEAEs was the last dose date +7 days for nonserious AEs and the last dose date +30 days for SAEs).
Abbreviations: AEs, adverse events; ASN, asenapine; ATS, all-treated set; BID, twice daily; MedDRA, Medical Dictionary for Regulatory Activities; OLZ, olanzapine; PBO, placebo; QD, once daily; SAEs, serious AEs; TEAEs, treatment-emergent AEs.