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Table 5 Treatment-emergent adverse events in ≥ 5% of patients based on exploratory analysis of the safety data

From: A one-year prospective study of the safety, tolerability and pharmacokinetics of the highest available dose of paliperidone palmitate in patients with schizophrenia

  Patients who completed the study on 150 mg eq. throughout Patients who did not complete the study on 150 mg eq. throughout
  Group A
(N = 100)
Group B
(N = 4)
Total
(N = 104)
Group C
(N = 86)
Group D
(N = 22)
Total
(N = 108)
Total no. patients with TEAEs 83 (83.0) 4 (100) 87 (83.7) 76 (88.4) 21 (95.5) 97 (89.8)
Nasopharyngitis 19 (19.0) 1 (25.0) 20 (19.2) 14 (16.3) 3 (13.6) 17 (15.7)
Insomnia 11 (11.0) 1 (25.0) 12 (11.5) 16 (18.6) 4 (18.2) 20 (18.5)
Weight increased 10 (10.0) 1 (25.0) 11 (10.6) 4 (4.7) 4 (18.2) 8 (7.4)
Upper respiratory tract infection 6 (6.0) 1 (25.0) 7 (6.7) 3 (3.5) 2 (9.1) 5 (4.6)
Injection site pain 15 (15.0) 0 15 (14.4) 10 (11.6) 7 (31.8) 17 (15.7)
Headache 13 (13.0) 0 13 (12.5) 11 (12.8) 4 (18.2) 15 (13.9)
Blood prolactin increased 7 (7.0) 0 7 (6.7) 8 (9.3) 4 (18.2) 12 (11.1)
Tachycardia 20 (20.0) 0 20 (19.2) 4 (4.7) 3 (13.6) 7 (6.5)
Orthostatic hypotension 9 (9.0) 0 9 (8.7) 6 (7.0) 3 (13.6) 9 (8.3)
Anxiety 7 (7.0) 0 7 (6.7) 4 (4.7) 4 (18.2) 8 (7.4)
Diarrhoea 6 (6.0) 0 6 (5.8) 6 (7.0) 1 (4.5) 7 (6.5)
Hypertension 8 (8.0) 0 8 (7.7) 1 (1.2) 2 (9.1) 3 (2.8)
Tremor 6 (6.0) 0 6 (5.8) 0 0 0
Pyrexia 5 (5.0) 1 (25.0) 6 (5.8) 0 0 0
Toothache 6 (6.0) 0 6 (5.8) 0 0 0
Akathisia 0 0 0 9 (10.5) 6 (27.3) 15 (13.9)
Psychotic disorder 0 0 0 8 (9.3) 1 (4.5) 9 (8.3)
Schizophrenia 0 0 0 8 (9.3) 1 (4.5) 9 (8.3)
Hyperprolactinaemia 0 0 0 5 (5.8) 3 (13.6) 8 (7.4)
Agitation 0 0 0 5 (5.8) 2 (9.1) 7 (6.5)
  1. Note: Group A consists of all patients who completed the study on 150 mg eq. and stayed on intensive PK sampling throughout; and Group B consists of all patients who completed the study on 150 mg eq. but were not on intensive PK sampling. Group C consists of patients who withdrew early while on 150 mg eq and intensive PK sampling. Group D consists of patients who completed the trial while on flexible dose and switched to non-intensive PK sampling (N = 9); patients who withdrew from the trial while on 150 mg eq. and switched to non-intensive sampling (N = 3); and patients who withdrew from the trial while on flexible dose and switched to non-intensive sampling (N = 10)