All Causality TEAEs | Treatment-Related AE | |||||||
---|---|---|---|---|---|---|---|---|
ETN–ETN (n = 21) | ETN–ACT (n = 20) | ACT (n = 18) | Total (N = 59) | ETN–ETN (n = 21) | ETN–ACT (n = 20) | ACT (n = 18) | Total (N = 59) | |
Patients with TEAEs, n (%) | 14 (66.7 %) | 14 (70.0 %) | 10 (55.6 %) | 38 (64.4 %) | 9 (42.9 %) | 10 (50.0 %) | 8 (44.4 %) | 27 (45.8 %) |
Total number of TEAEs | 22 | 38 | 25 | 85 | 11 | 22 | 13 | 46 |
Patients with SAEs, n (%) | 0 (0.0 %) | 0 (0.0 %) | 1 (5.6 %) | 1 (1.7 %) | 0 (0.0 %) | 0 (0.0 %) | 0 (0.0 %) | 0 (0.0 %) |
Total number of SAEs | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
Permanent discontinuation due to AE, n (%) | 1 (4.8 %) | 0 | 1 (5.6 %) | 2 (3.4 %) | – | – | – | – |