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Table 5 Incidence of treatment-emergent AEs by time period

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

Month of onset of AE 0-1 >1-2 >2-3 >3-6 >6-9 >9-12 >12
Subjects at each time point, n        
PBO/RIS 48 45 44 43 22 0 0
RIS/RIS 292 266 254 242 136 67 42
Direct-enroll 50 44 41 40 19 0 0
Any AE, n (%)        
PBO/RIS 39 (81) 11 (24) 9 (20) 21 (49) 3 (14)
RIS/RIS 197 (67) 82 (31) 80 (31) 117 (48) 51 (38) 33 (49) 8 (19)
Direct-enroll 40 (80) 21 (48) 18 (44) 23 (58) 3 (16)
Somnolence, n (%)        
PBO/RIS 15 (31) 1 (2) 2 (5) 1 (2) 0
RIS/RIS 55 (19) 4 (2) 8 (3) 9 (4) 2 (1) 3 (4) 0
Direct-enroll 16 (32) 4 (9) 2 (5) 2 (5) 0
Tremor, n (%)        
PBO/RIS 6 (13) 0 0 0 0
RIS/RIS 23 (8) 2 (1) 3 (1) 5 (2) 2 (1) 0 0
Direct-enroll 3 (6) 1 (2) 0 0 0
Insomnia, n (%)        
PBO/RIS 5 (10) 1 (2) 0 1 (2) 0
RIS/RIS 24 (8) 4 (2) 5 (2) 8 (3) 4 (3) 2 (3) 1 (2)
Direct-enroll 3 (6) 1 (2) 1 (2) 1 (3) 0
Hypertonia, n (%)        
PBO/RIS 6 (13) 0 0 0 2 (9)
RIS/RIS 27 (9) 1 (<1) 6 (2) 7 (3) 0 0 0
Direct-enroll 6 (12) 1 (2) 0 2 (5) 0
Weight increase, n (%)        
PBO/RIS 1 (2) 1 (2) 0 5 (12) 0
RIS/RIS 15 (5) 6 (2) 5 (2) 10 (4) 4 (3) 2 (3) 0
Direct-enroll 11 (22) 2 (5) 1 (2) 3 (8) 0
  1. PBO, placebo; RIS, risperidone.