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Table 3 Treatment-emergent adverse events (AEs)

From: Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial

Adverse events, n (%) Placebo, n = 83 Paliperidone palmitate
   234/39 mg, n = 72 234/156 mg, n = 72 234/234 mg, n = 85
Patients with ≥1 AE 57 (68.7) 49 (68.1) 53 (73.6) 55 (64.7)
Discontinuation due to AEs 7 (8.4) 6 (8.3) 7 (9.7) 5 (5.9)
Most common AEs*
   Insomnia 13 (15.7) 8 (11.1) 5 (6.9) 10 (11.8)
   Headache 7 (8.4) 11 (15.3) 9 (12.5) 6 (7.1)
   Schizophrenia exacerbation 8 (9.6) 6 (8.3) 10 (13.9) 4 (4.7)
   Injection site pain 5 (6.0) 10 (13.9) 2 (2.8) 7 (8.2)
   Anxiety 6 (7.2) 3 (4.2) 5 (6.9) 7 (8.2)
   Agitation 8 (9.6) 8 (11.1) 2 (2.8) 2 (2.4)
   Akathisia 5 (6.0) 1 (1.4) 5 (6.9) 5 (5.9)
   Psychotic disorder 6 (7.2) 3 (4.2) 4 (5.6) 2 (2.4)
   Dizziness 1 (1.2) 1 (1.4) 5 (6.9) 3 (3.5)
   Upper respiratory tract infection 1 (1.2) 0 1 (1.4) 5 (5.9)
   Constipation 3 (3.6) 2 (2.8) 4 (5.6) 0
Patients with ≥1 EPS-related AE 7 (8.4) 5 (6.9) 9 (12.5) 10 (11.8)
  1. Each paliperidone palmitate subject received 234 mg of paliperidone palmitate on day 1 and then their assigned dose day 8 and monthly thereafter.
  2. *Defined as ≥5% in any one group.
  3. EPS = extrapyramidal symptom.