| 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) |