Table 3.
Overview of TEAEs and Laboratory Value Abnormalities in Patients With and Without Cirrhosis
| Substudy 1 Patients Without Cirrhosis | Substudy 2 Patients With Cirrhosis | |||
|---|---|---|---|---|
| Group A DB OBV/PTV/r (n = 215) | Group B DB Placebo (n = 106) | Group B OL OBV/PTV/r (n = 106) | Group C OL OBV/PTV/r (n = 42) | |
| Any TEAE, n (%) | 148 (68.8)a | 60 (56.6) | 68 (64.2) | 31 (73.8) |
| TEAE leading to discontinuation, n (%) | 2 (0.9) | 0 | 0 | 1 (2.4) |
| Serious TEAE,b n (%) | 7 (3.3) | 2 (1.9) | 3 (2.8) | 2 (4.8) |
| Common TEAEs,c n (%) | ||||
| Nasopharyngitis | 36 (16.7) | 14 (13.2) | 8 (7.5) | 6 (14.3) |
| Headache | 19 (8.8) | 10 (9.4) | 7 (6.6) | 3 (7.1) |
| Peripheral edema | 11 (5.1)a | 0 | 4 (3.8) | 3 (7.1) |
| Nausea | 9 (4.2) | 4 (3.8) | 1 (0.9) | 3 (7.1) |
| Pyrexia | 4 (1.9) | 1 (0.9) | 1 (0.9) | 4 (9.5) |
| Decreased platelet count | 0 | 0 | 0 | 3 (7.1) |
| Postbaseline abnormalities in laboratory values (grade 3 or higher), n/N (%) | ||||
| ALT, >5× ULN | 1/213 (0.5) | 1/106 (0.9) | 0 | 0 |
| AST, >5× ULN | 0 | 1/106 (0.9) | 0 | 0 |
| Total bilirubin, >3× ULN | 0 | 0 | 0 | 1/42 (2.4) |
| Hemoglobin, <8 g/dL | 0 | 0 | 0 | 0 |
The only statistical comparisons of safety data performed were between groups A and B during the double‐blind period.
a
P < 0.05 Fisher's exact test (A versus B during the double‐blind period).
b
Definition in Supporting Information.
c
Occurring in >5% of patients in any group.
Abbreviations: AST, aspartate aminotransferase; DB, double‐blind; OL, open‐label.