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Table 2 Adverse events (Safety set)

From: Effects of recombinant human growth hormone treatment on growth, body composition, and safety in infants or toddlers with Prader-Willi syndrome: a randomized, active-controlled trial

  Eutropin group
(N = 17)
Comparator group
(N = 17)
Adverse events 17 (100.00) 16 (94.12)
Common adverse events (≥20% of subjects in total)
 Upper respiratory tract infection 11 (64.71) 10 (58.82)
 Nasopharyngitis 7 (41.18) 7 (41.18)
 Pyrexia 7 (41.18) 5 (29.41)
 Pneumonia 4 (23.53) 5 (29.41)
 Bronchitis 3 (17.65) 5 (29.41)
Adverse drug reactions 6 (35.29) 6 (35.29)
Common adverse drug reactions (≥5% of subjects in total)
 Hypothyroidism 3 (17.65) 1 (5.88)
 Thyroxine free decreased 0 (0.00) 2 (11.76)
Serious adverse events 8 (47.06) 7 (41.18)
 Infections and infestationsa 7 (41.18) 6 (35.29)
 Nervous system disordersb 0 (0.00) 2 (11.76)
 Enteritis 1 (5.88) 1 (5.88)
 Congestive cardiomyopathy 1 (5.88) 0 (0.00)
 Strabismus 1 (5.88) 0 (0.00)
 Middle ear effusion 0 (0.00) 1 (5.88)
Adverse events of special interest
 Sleep apnea syndrome 1 (5.88) 0 (0.00)
 Upper airway obstruction 0 (0.00) 0 (0.00)
Adverse events leading to investigational product withdrawal 1 (5.88) 3 (17.65)
Local reactions at injection site 5 (29.41) 11 (64.71)
 Warmth 2 (11.76) 2 (11.76)
 Erythema 5 (29.41) 10 (58.82)
 Swelling 2 (11.76) 2 (11.76)
  1. Data are the number of subjects (%)
  2. aInfections and infestations: bronchiolitis, bronchitis, pneumonia, upper respiratory tract infection, urinary tract infection and viral infection were included
  3. bNervous system disorders: febrile convulsion and seizure were included