Table 3. Treatment-Emergent Adverse Events Reported in ⩾2% of All Patients During Study Period III.
| Preferred term | n (%) | p-valuea | |||
|---|---|---|---|---|---|
| ER (N=139) | ENR–RIS (N=188) | ENR–OLZ (N=179) | ER vs ENR–RIS | ENR–RIS vs ENR–OLZ | |
| Weight increased | 4 (2.9) | 10 (5.3) | 20 (11.2) | 0.409 | 0.055 |
| Sedation | 5 (3.6) | 11 (5.9) | 12 (6.7) | 0.441 | 0.831 |
| Insomnia | 4 (2.9) | 16 (8.5) | 7 (3.9) | 0.038 | 0.085 |
| Headache | 7 (5.0) | 8 (4.3) | 9 (5.0) | 0.793 | 0.806 |
| Anxiety | 8 (5.8) | 8 (4.3) | 8 (4.5) | 0.608 | 1.000 |
| Somnolence | 6 (4.3) | 11 (5.9) | 5 (2.8) | 0.620 | 0.202 |
| Increased appetite | 3 (2.2) | 9 (4.8) | 5 (2.8) | 0.249 | 0.417 |
| Lethargy | 12 (8.6) | 3 (1.6) | 2 (1.1) | 0.005 | 1.000 |
| Diarrhea | 4 (2.9) | 10 (5.3) | 2 (1.1) | 0.409 | 0.036 |
| Dry mouth | 5 (3.6) | 5 (2.7) | 4 (2.2) | 0.749 | 1.000 |
| Extrapyramidal disorder | 5 (3.6) | 4 (2.1) | 3 (1.7) | 0.503 | 1.000 |
| Fatigue | 3 (2.2) | 4 (2.1) | 3 (1.7) | 1.000 | 1.000 |
| Akathisia | 3 (2.2) | 5 (2.7) | 2 (1.1) | 1.000 | 0.450 |
| Agitation | 4 (2.9) | 3 (1.6) | 3 (1.7) | 0.464 | 1.000 |
| Restlessness | 2 (1.4) | 5 (2.7) | 3 (1.7) | 0.703 | 0.724 |
| Suicidal ideation | 5 (3.6) | 2 (1.1) | 3 (1.7) | 0.140 | 0.678 |
ENR, early non-responders; ER, early responders; N, number of patients; n, number of events; OLZ, olanzapine; RIS, risperidone.
a
p-value is from Fisher's exact test.