Table 2.
Adverse events in Japanese and overseas patients
| Event | Japan GT1-2 N = 229 |
Overseas GT1-2 N = 670 |
Overall N = 899 |
|---|---|---|---|
| Any AE, n (%) | 125 (55) | 416 (62) | 541 (60) |
| Any DAA-relateda AE | 50 (22) | 234 (35) | 284 (32) |
| Any serious AE | 3 (1) | 11 (2) | 14 (2) |
| Any DAA-relateda serious AEs | 0 | 0 | 0 |
| Any AE leading to study drug discontinuation | 1 (< 1) | 1 (< 1) | 2 (< 1) |
| Any AE leading to study drug interruption | 0 | 1 (< 1) | 1 (< 1) |
| Common AEs (occurring in ≥ 5% of patients) | |||
| Headache | 13 (6) | 99 (15) | 112 (12) |
| Fatigue | 1 (< 1) | 80 (12) | 81 (9) |
| Viral upper respiratory tract infectionb | 28 (12) | 35 (5) | 63 (7) |
| Nausea | 8 (3) | 53 (8) | 61 (7) |
| Deaths | 0 | 1 (< 1)c | 1 (< 1)c |
AE adverse event, DAA direct acting antiviral
aDAA relatedness determined by study investigator
bAdverse events of common cold included per MedDRA version 20.0 that were previously coded as nasopharyngitis in MedDRA version 19.0
cOverseas patient died from adenocarcinoma attributed to enlarge peripancreatic nodes and determined to be not related to G/P