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Table 4 Treatment-emergent adverse events

From: Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program

  Randomized withdrawal study Extension study
Open-label Double-blind
Milnacipran Placebo Milnacipran Milnacipran
Patients, n (%) n = 116 n = 6 n = 14 N = 57
Any TEAEa 91 (78.4) 4 (66.7) 6 (42.9) 42 (73.7)
Nausea 38 (32.8) 0 0 10 (17.5)
Vomiting 16 (13.8) 0 0 5 (8.8)
Headache 12 (10.3) 1 (16.7) 0 4 (7.0)
Dizziness 10 (8.6) 0 0 3 (5.3)
Fatigue 7 (6.0) 0 0 1 (1.8)
Hot flush 7 (6.0) 0 0 2 (3.5)
Tachycardiab 7 (6.0) 0 1 (7.1) 6 (10.5)
Decreased appetite 5 (4.3) 0 0 6 (10.5)
Hyperhidrosis 5 (4.3) 0 0 1 (1.8)
Insomnia 5 (4.3) 0 0 1 (1.8)
Upper respiratory tract infection 5 (4.3) 0 1 (7.1) 0
Urinary tract infection 5 (4.3) 0 0 5 (8.8)
Abdominal pain 4 (3.4) 0 0 4 (7.0)
Gastroenteritis 4 (3.4) 0 0 1 (1.8)
Heart rate increasedb 4 (3.4) 0 0 4 (7.0)
Nasopharyngitis 4 (3.4) 0 0 2 (3.5)
Diarrhea 3 (2.6) 0 0 1 (1.8)
Dysmenorrhea 3 (2.6) 0 0 0
Irritability 3 (2.6) 0 0 0
Palpitations 3 (2.6) 0 0 1 (1.8)
Rash 3 (2.6) 0 0 0
Tremor 3 (2.6) 0 0 1 (1.8)
  1. aReported in ≥2 % of patients during the open-label period of the randomized withdrawal study; coded by MedDRA preferred term
  2. bTachycardia refers to an increase in heart rate that is greater than the age-corrected upper limit of normal. Heart rate increased refers to any increase, whether or not within the normal age-corrected range
  3. TEAE = treatment-emergent adverse event