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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