Table 3.

Results of safety monitoring

EventGroup 1 (Intermediate Conversion Factor)Group 2 (Higher Conversion Factor)Total
Core study periodn=16n=48n=64
 Adverse event, n (%)12 (75)37 (77)49 (77)
 Serious adverse event, n (%)4 (25)12 (25)16 (25)
 Fatal adverse event, n (%)01 (2)1 (2)
 Withdrawal due to adverse event, n (%)01 (2)1 (2)
 Blood transfusions, n (%)1 (11)2 (4)3
 Incidence of individual adverse events, n (%)a
  Headache1 (6)8 (17)9 (14)
  Nasopharyngitis0 (0)9 (19)9 (14)
  Hypertension1 (6)7 (15)8 (13)
  Vomiting2 (13)4 (8)6 (9)
  Abdominal pain1 (6)3 (6)4 (6)
  Bronchitis1 (6)3 (6)4 (6)
Extension periodn=9n=28n=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
  Nasopharyngitis0 (0)7 (25)7 (19)
  Headache0 (0)6 (21)6 (16)
  Hypertension0 (0)5 (18)5 (14)
  Bronchitis1 (11.1)2 (7)3 (8)
  Pharyngitis0 (0)3 (11)3 (8)
  • a Adverse events with an overall incidence ≥6%.