Table 3.
Patients with prespecified TEAEs of special interest (ATS)
| 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 (%) |
|
|---|---|---|---|---|
| Tier 1 | ||||
| ≥1 Tier 1 TEAEs | 7 (22.6) | 4 (12.9) | 3 (7.1) | 1 (6.3) |
| P* (95% CI) | 0.21 (0.081, 0.342) | 0.14 (0.025, 0.258) | 0.07 (0.000, 0.139) | 0.07 (0.000, 0.185) |
| EPS SMQ (narrow) | 4 (12.9) | 1 (3.2) | 0 (0.0) | 1 (6.3) |
| P* (95% CI) | 0.12 (0.018, 0.224) | 0.03 (0.000, 0.087) | – | 0.07 (0.000, 0.185) |
| Insomnia | 2 (6.5) | 2 (6.5) | 2 (4.8) | 0 (0.0) |
| P* (95% CI) | 0.07 (0.000, 0.163) | 0.06 (0.000, 0.136) | 0.05 (0, 0.106) | – |
| Somnolence, sedation, or hypersomnia | 2 (6.5) | 1 (3.2) | 1 (2.4) | 0 (0.0) |
| P* (95% CI) | 0.05 (0.000, 0.123) | 0.05 (0.000, 0.13) | 0.02 (0.000, 0.060) | – |
| Akathisia | 2 (6.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| P* (95% CI) | 0.07 (0.000, 0.150) | – | – | – |
| Dizziness | 1 (3.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| P* (95% CI) | 0.03 (0.000, 0.073) | – | – | – |
| Hypoesthesia oral or dysgeusia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| P* (95% CI) | – | – | – | – |
| Weight gain ≥7% | 4 (13.3) | 2 (6.5) | 5 (12.2) | 4 (26.7) |
| P* (95% CI) | 0.11 (0.019, 0.205) | 0.06 (0.000, 0.138) | 0.12 (0.023, 0.223) | 0.26 (0.081, 0.449) |
| Tier 2 | ||||
| ≥1 Tier 2 TEAEs | 5 (16.1) | 3 (9.7) | 6 (14.3) | 1 (6.3) |
| P* (95% CI) | 0.14 (0.041, 0.232) | 0.09 (0.000, 0.179) | 0.13 (0.039, 0.230) | 0.07 (0.000, 0.185) |
| Schizophrenia | 2 (6.5) | 2 (6.5) | 5 (11.9) | 1 (6.3) |
| P* (95% CI) | 0.06 (0.000, 0.123) | 0.06 (0.000, 0.134) | 0.11 (0.025, 0.191) | 0.07 (0.000, 0.185) |
| Weight increased | 3 (9.7) | 1 (3.2) | 1 (2.4) | 0 (0.0) |
| P* (95% CI) | 0.08 (0.000, 0.164) | 0.03 (0.000, 0.087) | 0.03 (0.000, 0.073) | – |
| Tier 3 | ||||
| ≥1 Tier 3 TEAEs | 16 (51.6) | 6 (19.4) | 12 (28.6) | 3 (18.8) |
Notes: P*, point estimate of adjusted proportion; P* and 95% CIs calculated using weighted formulae that accounted for pooled investigative site.
Abbreviations: ATS, all-treated set; ASN, asenapine; BID, twice daily; CI, confidence interval; EPS, extrapyramidal symptom; MedDRA, Medical Dictionary for Regulatory Activities; OLZ, olanzapine; PBO, placebo; QD, once daily; SMQ, standardized MedDRA query; TEAEs, treatment-emergent AEs.