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Table 3 Incidence of treatment-emergent adverse events a

From: An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

AEs, n (%) PBO/RIS RIS/RIS Direct-enroll All subjects
(n = 48) (n = 292) (n = 50) (N = 390)
Treatment-emergent AEs
Total 42 (88) 247 (85) 46 (92) 335 (86)
Most common AEs (≥ 10% in any group)
Somnolence 16 (33) 72 (25) 18 (36) 106 (27)
Headache 6 (13) 49 (17) 16 (32) 71 (18)
Weight increase 7 (15) 39 (13) 14 (28) 60 (15)
Hypertonia 7 (15) 37 (13) 8 (16) 52 (13)
Insomnia 7 (15) 35 (12) 4 (8) 46 (12)
Psychosis 3 (6) 31 (11) 7 (14) 41 (11)
Tremor 6 (13) 32 (11) 4 (8) 42 (11)
Rhinitis 4 (8) 29 (10) 1 (2) 34 (9)
Extrapyramidal disorder 5 (10) 23 (8) 2 (4) 30 (8)
Depression 5 (10) 17 (6) 5 (10) 27 (7)
Agitation 5 (10) 19 (7) 2 (4) 26 (7)
Fatigue 1 (2) 17 (6) 8 (16) 26 (7)
Tachycardia 9 (19) 16 (5) 1 (2) 26 (7)
Vomiting 6 (13) 19 (7) 1 (2) 26 (7)
Abdominal pain 1 (2) 10 (3) 9 (18) 20 (5)
Serious
Total 4 (8) 46 (16) 14 (28) 64 (16)
Psychosis 1 (2) 26 (9) 8 (16) 35 (9)
Suicide attempt 1 (2) 14 (5) 3 (6) 18 (5)
Aggressive reaction 0 5 (2) 1 (2) 6 (2)
Injury 0 3 (1) 2 (4) 5 (1)
Depression 0 4 (1) 0 4 (1)
Anxiety 0 2 (1) 1 (2) 3 (1)
Paranoid reaction 0 1 (<-1) 2 (4) 3 (1)
Emotional lability 0 1 (<-1) 1 (2) 2 (1)
Inflicted injury 0 2 (1) 0 2 (1)
Agitation 0 0 1 (2) 1 (<-1)
Convulsions 0 1 (<-1) 0 1 (<-1)
Diabetes mellitus 0 1 (<-1) 0 1 (<-1)
Delusion 0 0 1 (2) 1 (<-1)
Depression psychotic 0 0 1 (2) 1 (<-1)
Drug abuse 0 0 1 (2) 1 (<-1)
Gastrointestinal hemorrhage 1 (2) 0 0 1 (<-1)
Laboratory values abnormal 0 1 (<-1) 0 1 (<-1)
Medication error 0 0 1 (2) 1 (<-1)
Metastases not otherwise specified 1 (2) 0 0 1 (<-1)
Pharyngitis 0 1 (<-1) 0 1 (<-1)
Sarcoma 1 (2) 0 0 1 (<-1)
Schizophrenic reaction 0 1 (<-1) 0 1 (<-1)
Vomiting 1 (2) 0 0 1 (<-1)
  1. AE, adverse event.
  2. aIncidence is based on the number of subjects experiencing at least one AE, not the number of AEs.