Table 3.
Results of safety monitoring
| Event | Group 1 (Intermediate Conversion Factor) | Group 2 (Higher Conversion Factor) | Total |
|---|---|---|---|
| Core study period | n=16 | n=48 | n=64 |
| Adverse event, n (%) | 12 (75) | 37 (77) | 49 (77) |
| Serious adverse event, n (%) | 4 (25) | 12 (25) | 16 (25) |
| Fatal adverse event, n (%) | 0 | 1 (2) | 1 (2) |
| Withdrawal due to adverse event, n (%) | 0 | 1 (2) | 1 (2) |
| Blood transfusions, n (%) | 1 (11) | 2 (4) | 3 |
| Incidence of individual adverse events, n (%)a | |||
| Headache | 1 (6) | 8 (17) | 9 (14) |
| Nasopharyngitis | 0 (0) | 9 (19) | 9 (14) |
| Hypertension | 1 (6) | 7 (15) | 8 (13) |
| Vomiting | 2 (13) | 4 (8) | 6 (9) |
| Abdominal pain | 1 (6) | 3 (6) | 4 (6) |
| Bronchitis | 1 (6) | 3 (6) | 4 (6) |
| Extension period | n=9 | n=28 | n=37 |
| Adverse event, n (%) | 4 (44) | 23 (82) | 27 (73) |
| Serious adverse event, n (%) | 1 (11) | 8 (28) | 9 (24) |
| Fatal adverse event, n (%) | 0 (0) | 0 (0) | 0 (0) |
| Withdrawal due to adverse event, n (%) | 0 (0) | 0 (0) | 0 (0) |
| Incidence of individual adverse events, n (%)a | |||
| Nasopharyngitis | 0 (0) | 7 (25) | 7 (19) |
| Headache | 0 (0) | 6 (21) | 6 (16) |
| Hypertension | 0 (0) | 5 (18) | 5 (14) |
| Bronchitis | 1 (11.1) | 2 (7) | 3 (8) |
| Pharyngitis | 0 (0) | 3 (11) | 3 (8) |
a
Adverse events with an overall incidence ≥6%.