TABLE 5.
Number of patients with adverse events occurring in ≥3% of patients in multiple-dose phase (safety population)a
| Group and AE | No. (%) of patients with AE in:
|
|||
|---|---|---|---|---|
| Cohort 1 (1 to <2 yr) | Cohort 2 (2 to <6 yr) | Cohort 3 (6 to ≤12 yr) | Total (all cohorts) | |
| HSV-infected group | ||||
| At least one AE | 6 (42.2) | 8 (50.0) | 12 (66.7) | 26 (55.3) |
| Vomiting | 2 (15.4) | 1 (6.3) | 2 (11.1) | 5 (10.6) |
| Diarrhea | 1 (7.7) | 1 (6.3) | 2 (11.1) | 4 (8.5) |
| Headache | 0 (0.0) | 0 (0.0) | 4 (22.2) | 4 (8.5) |
| Nausea | 1 (7.7) | 0 (0.0) | 2 (11.1) | 3 (6.4) |
| Cough | 1 (7.7) | 1 (6.3) | 1 (5.6) | 3 (6.4) |
| Abdominal pain (upper) | 0 (0.0) | 1 (6.3) | 1 (5.6) | 2 (4.3) |
| Pyrexia | 2 (15.4) | 0 (0.0) | 0 (0.0) | 2 (4.3) |
| VZV-infected group | ||||
| At least one AE | 7 (38.9) | 10 (52.6) | 7 (43.8) | 24 (45.3) |
| Diarrhea | 2 (11.1) | 1 (5.3) | 3 (18.8) | 6 (11.3) |
| Vomiting | 5 (27.8) | 0 (0.0) | 0 (0.0) | 5 (9.4) |
| Pyrexia | 2 (11.1) | 1 (5.3) | 1 (6.3) | 4 (7.5) |
| Abdominal pain | 0 (0.0) | 0 (0.0) | 2 (12.5) | 2 (3.8) |
| Nausea | 0 (0.0) | 1 (5.3) | 1 (6.3) | 2 (3.8) |
| Cellulitis | 0 (0.0) | 1 (5.3) | 1 (6.3) | 2 (3.8) |
| Headache | 0 (0.0) | 0 (0.0) | 2 (12.5) | 2 (3.8) |
| Pruritus | 1 (5.6) | 0 (0.0) | 1 (6.3) | 2 (3.8) |
a
AEs are reported as treatment-emergent events (include all events regardless of drug relatedness). The number of patients in the various cohorts for the HSV-infected and VZV-infected groups were as follows: for the HSV-infected group, cohort 1 (n = 13), cohort 2 (n = 16), cohort 3 (n = 18), and total (n = 47); for VZV-infected group, cohort 1 (n = 18), cohort 2 (n = 19), cohort 3 (n = 16), and total (n = 53).