Table 3 Summary of AEs (Safety set) (N = 240)

Any treatment-emergent AE

222

147 (61.3)

Relationship to study drug

 No

122

89 (37.1)

 Yes

100

76 (31.7)

Outcome

 Completely recovered

140

94 (39.2)

 Condition still present and unchanged

46

42 (17.5)

 Condition improving

27

26 (10.8)

 Recovered with sequelae

6

6 (2.5)

 Condition deteriorated

2

2 (0.8)

 Completely recovered, condition still present and unchanged

1

1 (0.4)