Table 3 Adverse events
Event, MedDRA preferred term | All patients | Olanzapine | Non-Olanzapine | Risperidone | Non-Risperidone | Haloperidol | Non-Haloperidol |
|---|---|---|---|---|---|---|---|
(N = 558) | (N = 390) | (M = 168) | (N = 72) | (N = 486) | (N = 132) | (N = 426) | |
Treatment-emergent adverse events, n (%) | 37 (6.6) | 24 (6.2) | 13 (7.7) | 8 (11.1) | 29 (6.0) | 13 (9.8) | 24 (5.6) |
Dyskinesiaa, n (%) | 4a (0.7) | 2 (0.5) | 2 (1.2) | 0 (0.0) | 4 (0.8) | 3 (2.3) | 1 (0.2) |
Extrapyramidal disorder, n (%) | 4 (0.7) | 1 (0.3) | 3 (1.8) | 1 (1.4) | 3 (0.6) | 2 (1.5) | 2 (0.5) |
Sedation, n (%) | 4 (0.7) | 3 (0.8) | 1 (0.6) | 1 (1.4) | 3 (0.6) | 2 (1.5) | 2 (0.5) |
Dizziness postural, n (%) | 3 (0.5) | 3 (0.8) | 0 (0.0) | 0 (0.0) | 3 (0.6) | 2 (1.5) | 1 (0.2) |
Weight increased, n (%) | 3 (0.5) | 3 (0.8) | 0 (0.0) | 1 (1.4) | 2 (0.4) | 0 (0.0) | 3 (0.7) |
Akathisia, n (%) | 2 (0.4) | 2 (0.5) | 0 (0.0) | 1 (1.4) | 1 (0.2) | 0 (0.0) | 2 (0.5) |
Oculogyric crisis, n (%) | 2 (0.4) | 2 (0.5) | 0 (0.0) | 1 (1.4) | 1 (0.2) | 0 (0.0) | 2 (0.5) |
Salivary hypersecretion, n (%) | 2 (0.4) | 1 (0.3) | 1 (0.6) | 1 (1.4) | 1 (0.2) | 0 (0.0) | 2 (0.5) |
Adverse events considered related to primary AP medication, n (%) | 33 (5.9) | 21 (5.4) | 12 (7.1) | 8 (11.1) | 25 (5.1) | 12 (9.1) | 21 (4.9) |
Serious adverse events, n (%) | 4 (0.7) | 2 (0.5) | 2 (1.2) | 0 (0.0) | 4 (0.8) | 3 (2.3) | 1 (0.2) |
Serious adverse events considered related to primary AP medication, n (%) | 2 (0.4) | 1 (0.3) | 1 (0.6) | 0 (0.0) | 2 (0.4) | 2 (1.5) | 0 (0.0) |
Clinically significant adverse events resulting in discontinuation, n (%) | 2 (0.4) | 1 (0.3) | 1 (0.6) | 1 (1.4) | 1 (0.2) | 0 (0.0) | 2 (0.5) |