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Table 3 Overall safety during double-blind treatment period (safety population)

From: Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial

  Placebo (n = 93)
n (%)
Duloxetine (n = 91)
n (%)
TEAEs≥1, total 58 (62.37) 75 (82.42)
 Mild 25 (26.88) 34 (37.36)
 Moderate 29 (31.18) 33 (36.26)
 Severe 4 (4.30) 8 (8.79)
Most frequently reported TEAEs (≥10%)
 Nausea 14 (15.05) 23 (25.27)
 Headache 10 (10.75) 13 (14.29)
 Vomiting 5 (5.38) 14 (15.38)
 Decreased appetite 3 (3.23) 14 (15.38)
Columbia Suicidal-Severity Rating Scale
 Suicidal ideation or behavior 3 (3.23) 6 (6.59)
 Non-suicidal self-injurious behavior 1 (1.08) 0
Serious adverse events 0 2 (2.2)
Discontinuation due to adverse events 1 (1.08) 5 (5.49)
 Diarrhea 1 (1.08) 0
 Nausea 0 1 (1.1)
 Somnolence 0 1 (1.1)
 Anxiety 0 1 (1.1)
 Depressed mood 0 1 (1.1)
 Suicidal behavior 0 1 (1.1)
Death 0 0
  1. n number of patients, TEAE treatment-emergent adverse events