Table 4.
Adverse events in the safety population
| Adverse event* | Patient population, n (%) | ||
|---|---|---|---|
| Adults (n = 9) | Children (n = 5) | Combined (N = 14) | |
| Headache | 4 (44) | 2 (40) | 6 (43) |
| Nasopharyngitis | 3 (33) | 2 (40) | 5 (36) |
| Abdominal pain, upper | 1 (11) | 3 (60) | 4 (29) |
| Nausea | 3 (33) | 1 (20) | 4 (29) |
| Diarrhea | 2 (22) | 1 (20) | 3 (21) |
| Cough | 0 | 3 (60) | 3 (21) |
| Rhinorrhea | 2 (22) | 1 (20) | 3 (21) |
| Dyspepsia | 1 (11) | 1 (20) | 2 (14) |
| Vomiting | 1 (11) | 1 (20) | 2 (14) |
| Sinusitis | 2 (22) | 0 | 2 (14) |
| Urinary tract infection | 1 (11) | 1 (20) | 2 (14) |
| Epistaxis | 2 (22) | 0 | 2 (14) |
| Back pain | 2 (22) | 0 | 2 (14) |
| Pain in extremity | 2 (22) | 0 | 2 (14) |
| Hematuria | 2 (22) | 0 | 2 (14) |
| Dysmenorrhea | 1 (11) | 1 (20) | 2 (14) |
Adverse events were coded by version 18.0 of the Medical Dictionary for Regulatory Activities using preferred terms.
*
Shown are events that occurred in ≥2 patients as of the data cutoff date for the interim analysis, regardless of the relationship to the study drug.