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Table 6 Adverse events in placebo controlled trials

From: Atypical antipsychotics in bipolar disorder: systematic review of randomised trials

   Events/total patients Event rate (%)   
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]        
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]        
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
  1. NNTp is shown in bold, indicating fewer events with treatment than placebo. More events with treatment than placebo, NNH, is in plain text