Table 4.
Tolerability overview of the Taiwanese subgroup (n = 56) and the overall RELAY safety population (n = 446)
| Events, n (%) | Taiwanese subgroup | Overall RELAY safety populationa | ||
|---|---|---|---|---|
| RAM+ERL (n = 26) | PBO+ERL (n = 30) | RAM+ERL (n = 221) | PBO+ERL (n = 225) | |
| Any TEAE | 26 (100) | 30 (100) | 221 (100) | 225 (100) |
| Any grade ≥ 3 TEAE | 16 (62) | 9 (30) | 159 (72) | 121 (54) |
| Any TE-SAE | 11 (42) | 5 (17) | 65 (29) | 47 (21) |
| Discontinued due to AE | 1 (4) | 0 | 28 (13) | 24 (11) |
| Discontinued due to SAE | 0 | 0 | 10 (5) | 9 (4) |
| AEs leading to death, on study treatment | 0 | 0 | 2 (1) | 0 |
| AEs leading to death, within 30 days of discontinuation | 0 | 0 | 4 (2) | 0 |
aData published in Nakagawa et al. 2019 [20]
AE adverse event, ERL erlotinib, PBO placebo, RAM ramucirumab, SAE serious adverse event, TEAE treatment-emergent adverse event, TE-SAE treatment-emergent serious adverse event