Table 6 Adverse events in placebo controlled trials
From: Atypical antipsychotics in bipolar disorder: systematic review of randomised trials
| Â | Â | Events/total patients | Event rate (%) | Â | Â | ||
|---|---|---|---|---|---|---|---|
Event | Trials | Treatment | Placebo | Treatment | Placebo | Relative Risk (95% CI) | NNH/NNTp (95% CI) |
Less than 6 weeks [24, 26, 28, 30-35 37, 38] | Â | Â | Â | Â | Â | Â | Â |
Measured weight increase >7% | 4 | 12/469 | 8/408 | 3 | 2 | 1.14 (0.5 to 2.8) | not calculated |
Treatment emergent weight gain | 2 | 20/266 | 6/272 | 8 | 2 | 3.4 (1.4 to 8.4) | 19 (11 to 59) |
Treatment emergent akathisia | 5 | 73/738 | 26/599 | 10 | 4 | 2.2 (1.4 to 3.5) | 18 (12 to 35) |
Treatment emergent extrapyramidal disorder | 5 | 115/566 | 30/477 | 20 | 6 | 3.5 (2.4 to 5.1) | 7.1 (5.6 to 10) |
Treatment emergent tremor | 5 | 46/618 | 16/529 | 7 | 3 | 2.5 (1.4 to 4.3) | 23 (14 to 53) |
Treatment emergent somnolence | 11 | 340/1293 | 96/1244 | 26 | 8 | 3.5 (2.8 to 4.3) | 5.4 (4.7 to 6.4) |
Treatment emergent depression | 2 | 10/145 | 10/144 | 7 | 7 | 1.0 (0.4 to 2.3) | not calculated |
6–12 weeks [20, 22, 39, 41-43] |  |  |  |  |  |  |  |
Measured weight increase >7% | 4 | 136/1151 | 15/803 | 12 | 2 | 6.4 (3.9 to 11) | 10 (8.3 to 13) |
Treatment emergent weight gain | 2 | 76/336 | 9/212 | 23 | 4 | 4.7 (2.5 to 9.1) | 5.4 (4.2 to 7.6) |
Treatment emergent akathisia | 4 | 7/209 | 12/198 | 3 | 6 | 0.6 (0.2 to 1.4) | not calculated |
Treatment emergent extrapyramidal disorder | 3 | 79/800 | 31/448 | 10 | 7 | 1.6 (1.04 to 2.4) | 33 (16 to infinity) |
Treatment emergent tremor | 3 | 67/438 | 25/313 | 15 | 8 | 1.6 (1.1 to 2.5) | 14 (8.5 to 36) |
Treatment emergent somnolence | 6 | 450/1487 | 109/1015 | 30 | 11 | 2.7 (2.2 to 3.3) | 5.1 (4.4 to 6.1) |
Treatment emergent depression | 3 | 49/438 | 25/313 | 11 | 8 | 1.1 (0.7 to 1.7) | not calculated |
More than 12 weeks [46, 48, 49] | Â | Â | Â | Â | Â | Â | Â |
Measured weight increase >7% | 3 | 57/332 | 6/244 | 17 | 2 | 6.6 (3.0 to 15) | 6.8 (5.2 to 9.9) |
Treatment emergent weight gain | 2 | 28/276 | 5/184 | 10 | 3 | 4.2 (1.6 to 11) | 13 (9 to 32) |
Treatment emergent somnolence | 3 | 20/353 | 12/267 | 6 | 4 | 1.5 (0.7 to 3.0) | not calculated |