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Table 7 Adverse events in active controlled trials

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

   Events/total patients Event rate (%)   
Event Trials Treatment Active control Treatment Active control Relative Risk (95% CI) NNTp or NNH (95% CI)
Less than 6 weeks [27, 30, 37]        
Treatment emergent tremor 3 24/331 26/323 7 8 0.9 (0.5 to 1.5) not calculated
Treatment emergent somnolence 3 69/331 47/323 21 15 1.5 (1.1 to 2.0) 16 (8.3 to 210)
6–12 weeks [21, 40, 41, 42, 43]        
Measured weight increase >7% 3 152/536 39/515 31 13 3.6 (2.6 to 5.0) 4.8 (4.0 to 6.1)
Treatment emergent weight gain 3 62/398 21/380 16 6 2.9 (1.8 to 4.6) 10 (7.0 to 17)
Treatment emergent akathisia 4 42/618 110/585 7 19 0.4 (0.3 to 0.5) 8.3 (6.4 to 12)
Treatment emergent extrapyramidal disorder 3 27/511 148/490 5 30 0.2 (0.1 to 0.3) 4.0 (3.4 to 4.9)
Treatment emergent tremor 4 39/618 122/585 6 21 0.3 (0.2 to 0.4) 6.9 (5.5 to 9.3)
Treatment emergent somnolence 5 133/705 72/684 19 11 1.8 (1.4 to 2.4) 12 (8.3 to 22)
More than 12 weeks [45, 47]        
Measured weight increase >7% 2 93/340 43/337 27 13 2.2 (1.6 to 3.0) 6.9 (4.9 to 12)
Treatment emergent weight gain 2 45/342 25/340 13 7 1.8 (1.1 to 2.8) 17 (10 to 79)
Treatment emergent somnolence 2 64/342 31/340 19 9 2.1 (1.4 to 3.0) 10 (6.8 to 23)
Treatment emergent depression 2 88/342 63/340 26 19 1.4 (1.1 to 1.8) 14 (7.5 to 100)
  1. NNTp is shown in bold, indicating fewer events with treatment than placebo. More events with treatment than placebo, NNH, is in plain text. Active comparators were haloperidol, lithium, or divalproex