Table 6 Summary of AEs (ITT population)
SMV + PegIFNα-2a/RBV treatment phase | Entire treatment phase | |
|---|---|---|
n (%) | (N = 141) | (N = 141) |
Any AE | 128 (90.8) | 131 (92.9) |
Worst Grade 1 or 2 | 87 (61.7) | 81 (57.4) |
Worst Grade 3 | 36 (25.5) | 45 (31.9) |
Worst Grade 4 | 5 (3.5) | 5 (3.5) |
Worst Grade 3/4, at least possibly related to SMV | 9 (6.4) | 9 (6.4) |
Treatment-related AE | 127 (90.1) | 131 (92.9) |
At least possibly related to SMV | 93 (66.0) | 93 (66.0) |
At least possibly related to RBV | 99 (70.2) | 109 (77.3) |
At least possibly related to PegIFNα-2a | 123 (87.2) | 126 (89.4) |
Any AE with fatal outcome | 0 | 0 |
Any SAE | 5 (3.5) | 9 (6.4) |
At least possibly related to SMV | 0 | 0 |
AE leading to permanent stop of at least one drug | 6 (4.3) | 9 (6.4) |
SMVa | 3 (2.1) | 3 (2.1) |
PegIFNα-2a and/or RBV | 3 (2.1) | 6 (4.3) |
Events of special interest | 17 (12.1) | 17 (12.1) |
Increased bilirubin | 17 (12.1) | 17 (12.1) |
Events of clinical interest | 78 (55.3) | 87 (61.7) |
Rash (any type)b | 31 (22.0) | 36 (25.5) |
Pruritus | 25 (17.7) | 26 (18.4) |
Photosensitivity conditions | 8 (5.7) | 8 (5.7) |
Neutropenia | 33 (23.4) | 38 (27.0) |
Anemia | 11 (7.8) | 23 (16.3) |
Dyspnea | 15 (10.6) | 17 (12.1) |