Table 2.
Most common adverse events* (≥4% of subjects) by severity and relationship to study drug (N = 100)
| Adverse event,% of subjects† | Total | Mild | Moderate | Severe | Related to study drug |
|---|---|---|---|---|---|
| Gastrointestinal disorders‡ |
5 |
2 |
3 |
0 |
0 |
| Infections |
36 |
20 |
14 |
2|| |
1¶ |
| Bronchitis |
7 |
0 |
7 |
0 |
0 |
| Rhinitis |
19 |
16 |
3 |
0 |
1¶ |
| Upper respiratory tract infection |
9 |
6 |
3 |
0 |
0 |
| Respiratory, thoracic, and mediastinal disorders§ |
4 |
3 |
1 |
0 |
0 |
| Dermatitis | 4 | 4 | 0 | 0 | 1¶ |
*Adverse events were defined as treatment-emergent events, occurring after study drug initiation and within 100 days after the last dose of study drug.
†Subjects could have experienced more than 1 adverse event.
‡Includes anal stenosis, enteritis, and teething.
§Includes bronchopulmonary dysplasia, rhinorrhea, and tonsillar hypertrophy.
||One case each of pneumonia and tonsillitis.
¶Possibly related to study drug.