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Table 4 Adverse events (safety analysis set)

From: A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients

  Placebo (n = 196) Duloxetine (n = 194) p Valuea
AEs 123 (62.8) 148 (76.3) 0.0042b
ADRs 70 (35.7) 125 (64.4) <0.0001b
Serious AEs 1 (0.5) 1 (0.5) 1.000
Serious ADRs 0 (0.0) 1 (0.5) 0.4974
Discontinuations due to AEs 15 (7.7) 14 (7.2) 1.000
Discontinuations due to ADRs 10 (5.1) 14 (7.2) 0.4077
AEs by preferred term    
 Somnolence 21 (10.7) 51 (26.3) <0.0001b
 Nausea 9 (4.6) 42 (21.6) <0.0001b
 Constipation 8 (4.1) 29 (14.9) 0.0002b
 Nasopharyngitis 29 (14.8) 26 (13.4) 0.7715
 Dry mouth 7 (3.6) 14 (7.2) 0.1218
 Decreased appetite 1 (0.5) 13 (6.7) 0.0008b
 Dizziness 2 (1.0) 11 (5.7) 0.0112b
 Headache 6 (3.1) 9 (4.6) 0.4437
 Fatigue 6 (3.1) 9 (4.6) 0.4437
 Diarrhea 7 (3.6) 8 (4.1) 0.7990
  1. ADR adverse drug reaction, AE adverse event
  2. Values are n (%)
  3. aFisher’s exact test
  4. bStatistically significant at a two-sided level of 0.05