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Table 5 Overview of adverse events (safety population)

From: Bipolar II compared with bipolar I disorder: baseline characteristics and treatment response to quetiapine in a pooled analysis of five placebo-controlled clinical trials of acute bipolar depression

AE categorya Quetiapine Placebo Lithium Paroxetine
  BPI
(n = 1217)
BPII
(n = 632)
BPI
(n = 500)
BPII
(n = 242)
BPI
(n = 87)
BPII
(n = 49)
BPI
(n = 76)
BPII
(n = 45)
Any AE, n (%) 933 (76.7) 471 (74.5) 362 (72.4) 161 (66.5) 47 (54.0) 32 (65.3) 54 (71.1) 30 (66.7)
Any AE leading to discontinuation of treatment, n (%) 120 (9.9) 90 (14.2) 19 (3.8) 10 (4.1) 5 (5.7) 5 (10.2) 9 (11.8) 2 (4.4)
Any SAE (including outcome of death), n (%) 46 (3.8) 8 (1.3) 24 (4.8) 2 (0.8) 2 (2.3) 1 (2.0) 8 (10.5) 1 (2.2)
Any SAE leading to discontinuation of treatment, n (%) 30 (2.5) 4 (0.6) 13 (2.6) 1 (0.4) 2 (2.3) 0 (0.0) 5 (6.6) 0 (0.0)
Any other significant AEb, n (%) 17 (1.4) 12 (1.9) 5 (1.0) 1 (0.4) 3 (3.4) 0 (0.0) 1 (1.3) 1 (2.2)
  1. Summary tables for AEs include those reported between the first dose and 30 days final dose of study medication
  2. AE adverse event, BP bipolar, SAE serious AE
  3. aPatients with multiple events in the same category are counted only once in that category
  4. bAny AE that led to dose of treatment being changed or temporarily stopped, or deemed by the sponsor to be significant, excluding AEs reported as SAEs or led to discontinuation of treatment