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Table 6 Adverse events occurring in greater than or equal to 5 % of patients in any group by preferred term in decreasing frequency (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

  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)
Patients with events, 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)
 Dry mouth 351 (28.8) 198 (31.3) 40 (8.0) 23 (9.5) 4 (4.6) 6 (12.2) 7 (9.2) 5 (11.1)
 Somnolence 287 (23.6) 130 (20.6) 28 (5.6) 18 (7.4) 5 (5.7) 7 (14.3) 1 (1.3) 6 (13.3)
 Sedation 216 (17.7) 128 (20.3) 32 (6.4) 14 (5.8) 1 (1.1) 0 (0.0) 6 (7.9) 4 (8.9)
 Dizziness 163 (13.4) 94 (14.9) 39 (7.8) 14 (5.8) 4 (4.6) 2 (4.1) 6 (7.9) 2 (4.4)
 Headache 107 (8.8) 65 (10.3) 69 (13.8) 43 (17.8) 8 (9.2) 5 (10.2) 12 (15.8) 7 (15.6)
 Constipation 103 (8.5) 49 (7.8) 16 (3.2) 11 (4.5) 2 (2.3) 2 (4.1) 6 (7.9) 0 (0.0)
 Nausea 85 (7.0) 47 (7.4) 50 (10.0) 22 (9.1) 10 (11.5) 13 (26.5) 7 (9.2) 8 (17.8)
 Fatigue 75 (6.2) 58 (9.2) 22 (4.4) 14 (5.8) 1 (1.1) 1 (2.0) 1 (1.3) 3 (6.7)
 Dyspepsia 51 (4.2) 33 (5.2) 14 (2.8) 6 (2.5) 3 (3.4) 1 (2.0) 2 (2.6) 0 (0.0)
 Upper respiratory tract infection 41 (3.4) 15 (2.4) 29 (5.8) 12 (5.0) 2 (2.3) 0 (0.0) 2 (2.6) 0 (0.0)
 Diarrhea 39 (3.2) 21 (3.3) 24 (4.8) 19 (7.9) 2 (2.3) 7 (14.3) 6 (7.9) 2 (4.4)
 Insomnia 34 (2.8) 10 (1.6) 33 (6.6) 15 (6.2) 8 (9.2) 4 (8.2) 8 (10.5) 8 (17.8)
 Tremor 26 (2.1) 16 (2.5) 4 (0.8) 2 (0.8) 3 (3.4) 5 (10.2) 2 (2.6) 1 (2.2)
 Pollakiuria 16 (1.3) 3 (0.5) 9 (1.8) 2 (0.8) 2 (2.3) 4 (8.2) 0 (0.0) 1 (2.2)
 Asthenia 14 (1.2) 13 (2.1) 1 (0.2) 4 (1.7) 0 (0.0) 5 (10.2) 2 (2.6) 0 (0.0)
 Decreased appetite 15 (1.2) 6 (0.9) 3 (0.6) 5 (2.1) 0 (0.0) 0 (0.0) 4 (5.3) 2 (4.4)
 Influenza 15 (1.2) 17 (2.7) 9 (1.8) 6 (2.5) 2 (2.3) 1 (2.0) 0 (0.0) 3 (6.7)
 Anxiety 13 (1.1) 17 (2.7) 13 (2.6) 10 (4.1) 4 (4.6) 1 (2.0) 3 (3.9) 3 (6.7)