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. 2018 Aug 1;235(10):2859–2869. doi: 10.1007/s00213-018-4977-6

Table 4.

Summary of adverse events (AEs) and AEs occurring in at least 5% of the patients in any of the treatment groups

Placebo group (n = 177) Quetiapine XR 300 mg group (n = 179) Quetiapine XR 150 mg group (n = 74)
Patients n (%) Number of AEs Patients n (%) Number of AEs Patients n (%) Number of AEs
AEs 81 (45.8) 155 149 (83.2) 432 55 (74.3) 144
Drug-related AEs 52 (29.4) 88 133 (74.3) 331 50 (67.6) 107
Deaths 1 (0.6) 0 0 0 0 0
SAEs 2 (1.1) 2 0 0 1 (1.4) 1
Drug-related SAEs 0 0 0 0 0 0
AEs leading to discontinuation 16 (9.0) 17 27 (15.1) 35 6 (8.1) 8
Drug-related AEs leading to discontinuation 11 (6.2) 12 23 (12.8) 30 5 (6.8) 7
Patients (n) Patients (%) Patients (n) Patients (%) Patients (n) Patients (%)
GI disorders 22 12.4 34 19.0 15 20.3
 Constipation 3 1.7 14 7.8 10 13.5
General disorders and administration site conditions 10 5.6 61 34.1 12 16.2
 Malaise 2 1.1 16 8.9 3 4.1
 Thirst 5 2.8 50 27.9 9 12.2
Infections and infestations 22 12.4 38 21.2 15 20.3
 Nasopharyngitis 19 10.7 26 14.5 12 16.2
Investigations 16 9.0 41 22.9 15 20.3
 ALT increased 0 0 8 4.5 4 5.4
 AST increased 1 0.6 2 1.1 4 5.4
 Blood creatine phosphokinase increased 1 0.6 5 2.8 7 9.5
 Blood prolactin increased 5 2.8 13 7.3 4 5.4
Nervous systems disorders 17 9.6 95 53.1 29 39.2
 Akathisia 4 2.3 15 8.4 7 9.5
 Dizziness 1 0.6 5 2.8 4 5.4
 Somnolence 4 2.3 80 44.7 26 35.1
Psychiatric disorders 20 11.3 12 6.7 2 2.7
 Depression 10 5.6 4 2.2 1 1.4

AEs adverse events, SAEs serious adverse events, GI gastrointestinal, ALT alanine aminotransferase, AST aspartate aminotransferase