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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