TABLE 4.
SAEs Grade 3 or 4 (Requiring Medical Attention), Most Common Clinical Events in the Neonatal Period and Beyond, and Congenital Defects/Inborn Errors of Metabolism
| SAEs Grade 3 or 4 | ||
|---|---|---|
| No. of Subjects | % of Subjects (N = 236) | |
| Laboratory: hematologic SAEs | 38 | 16 |
| Laboratory: blood chemistry SAEs | 24 | 10 |
| Laboratory: liver/hepatic SAEs | 14 | 6 |
| Clinical: gastrointestinal SAEs | 9 | 4 |
| Clinical: respiratory SAEs | 9 | 4 |
| Total subjects with SAEsa | 89 | 38 |
| Neonatal conditions | ||
| Hematologic disordersb | 23 | 10 |
| Infections/infestations | 17 | 7 |
| Pregnancy/puerperium/perinatal disorders | 11 | 5 |
| Respiratory, thoracic mediastinal disorders | 8 | 3 |
| Eye disorders | 8 | 3 |
| Metabolism/nutrition disorders | 6 | 3 |
| Skin/soft tissue disorders | 5 | 2 |
| Total neonatal conditions | 70 | 30 |
| Conditions beyond neonatal periodc | ||
| Respiratory infections | 107 | 45 |
| Gastrointestinal infections | 52 | 22 |
| Hematologic disorders | 42 | 18 |
| Systemic viral infections | 24 | 10 |
| Allergic/autoimmune diseases | 22 | 9 |
| Skin and tissue infections | 20 | 8 |
| Congenital abnormalities/inborn errors metabolism (18 subjects) | ||
| Urinary/genital tract malformations | 8 | 3 |
| Hydrocele | 5 | — |
| Cryptorchism | 1 | — |
| Inguinal hernia | 1 | — |
| Pelvic-ureteric obstruction | 1 | — |
| Congenital heart defects | 8 | 3 |
| Ventricular septal defect | 3 | — |
| Patent ductus arteriosus | 1 | — |
| Congenital pulmonary artery stenosis | 1 | — |
| Congenital pulmonary hypertension | 1 | — |
| Complex congenital heart disease | 1 | — |
| Tetralogy of Fallot | 1 | — |
| Congenital hypothyroidism | 2 | 1 |
| Congenital lacrimal gland anomaly | 1 | 1 |
| Hypertelorism of orbit | 1 | 1 |
| Glucose-6-phosphate hydrogenase deficiency | 2 | 1 |
| Inborn error of bilirubin metabolism | 1 | 1 |
| Trisomy 21 | 1 | 1 |
| Total number of conditions | 24 | |
| Total number of events | 398 | |
| Total number of subjects with events | 144 | |
—, percent figures not given for subcategories.
a
Subjects may have >1 SAE.
b
Anemia in 22 subjects.
c
Conditions with <3% frequency are not listed.