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Table 3 Common AEs and ADRs

From: A double-blind randomized study assessing safety and efficacy following one-year adjunctive treatment with bitopertin, a glycine reuptake inhibitor, in Japanese patients with schizophrenia

  5 mg (n = 15) 10 mg (n = 73) 20 mg (n = 73) Total (n = 161)
Patients with at least 1 AE, n (%) 11 (73.3) 64 (87.7) 67 (91.8) 142 (88.2)
Total number of AEs, n 23 165 223 411
AEs with an incidence of more than 5 %
 Nasopharyngitis 3 (20.0) 31 (42.5) 29 (39.7) 63 (39.1)
 Somnolence - 9 (12.3) 18 (24.7) 27 (16.8)
 Worsening of schizophreniaa 2 (13.3) 4 (5.5) 11 (15.1) 17 (10.6)
 Headache - 5 (6.8) 7 (9.6) 12 (7.5)
 Insomnia associated with worsening schizophreniab - 3 (4.1) 9 (12.3) 12 (7.5)
Patients with at least 1 ADR, n (%) 2 (13.3) 35 (47.9) 41 (56.2) 78 (48.4)
Total number of ADRs, n 2 56 81 139
ADRs with an incidence of more than 2 %
 Somnolence - 8 (11.0) 18 (24.7) 26 (16.1)
 Worsening of schizophreniaa 1 (6.7) 4 (5.5) 7 (9.6) 12 (7.5)
 Insomnia associated with worsening schizophreniab   2 (2.7) 4 (5.5) 6 (3.7)
 Parkinsonism 1 (6.7) 4 (5.5) - 5 (3.1)
 Headache - 1 (1.4) 3 (4.1) 4 (2.5)
 Akathisia - 1 (1.4) 3 (4.1) 4 (2.5)
  1. Abbreviations: ADR adverse drug reaction, AE adverse event
  2. a“Worsening of schizophrenia” was coded to “schizophrenia” by Medical Dictionary for Regulatory Activities (MedDRA) version 14.1 preferred term
  3. b“Insomnia associated with worsening schizophrenia” was coded to “insomnia related to another mental condition” by MedDRA version 14.1 preferred term