Table 5.
Most common AEs occurring in the Taiwanese subgroup and the overall RELAY safety population
| 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 grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| TEAEsb | ||||||||
| Diarrhea | 15 (58) | 0 | 21 (70) | 0 | 155 (70) | 16 (7) | 160 (71) | 3 (1) |
| Dermatitis acneiform | 15 (58) | 5 (19) | 13 (43) | 2 (7) | 149 (67) | 33 (15) | 153 (68) | 20 (9) |
| Paronychia | 12 (46) | 0 | 19 (63) | 0 | 118 (53) | 9 (4) | 114 (51) | 7 (3) |
| Alanine aminotransferase increased | 3 (12) | 0 | 6 (20) | 0 | 94 (43) | 19 (9) | 70 (31) | 17 (8) |
| Insomnia | 10 (39) | 0 | 8 (27) | 0 | NR | NR | NR | NR |
| Stomatitis | 9 (35) | 1 (4) | 11 (37) | 0 | 92 (42) | 4 (2) | 82 (36) | 3 (1) |
| Aspartate aminotransferase increased | 5 (19) | 0 | 3 (10) | 0 | 92(42) | 11 (5) | 58 (26) | 10 (4) |
| Dry skin | 4 (15) | 0 | 6 (20) | 0 | 83 (38) | 0 | 91 (40) | 5 (2) |
| Alopecia | 1 (4) | 0 | 1 (3) | 0 | 75 (34) | 0 | 44 (20) | 0 |
| Pruritis | 9 (35) | 0 | 5 (17) | 0 | 51 (23) | 2 (<1) | 66 (29) | 2 (<1) |
| Proteinuria | 9 (35) | 1 (4) | 2 (7) | 0 | 75 (40) | 6 (3) | 19 (8) | 0 |
| Epistaxis | 6 (23) | 0 | 2 (7) | 0 | 74 (33) | 0 | 27 (12) | 0 |
| Blood bilirubin increased | 8 (31) | 0 | 8 (27) | 0 | 68 (31) | 3 (1) | 70 (31) | 2 (<1) |
| Cough | 8 (31) | 0 | 7 (23) | 0 | 48 (22) | 1 (<1) | 35 (16) | 0 |
| Rash | 7 (27) | 0 | 14 (47) | 0 | 39 (18) | 2 (<1) | 54 (24) | 5 (2) |
| Any TE-SAEc | 11 (42) | 10 (39) | 5 (17) | 4 (13) | 65 (29) | 50 (23) | 47 (21) | 35 (16) |
| Pneumonia | 3d (12) | 3 (12) | 0 | 0 | 7 (3) | 6 (3) | 1 (<1) | 0 |
| Skin infection | 2 (8) | 2 (8) | 0 | 0 | 2 (<1) | 2 (<1) | 0 | 0 |
| Pneumothorax | 0 | 0 | 2 (7) | 1 (3) | 4 (2) | 1 (<1) | 3 (<1) | 2 (<1) |
| Any TE-AESIe | 19 (73) | 5 (19) | 6 (20) | 2 (7) | 176 (80) | 63 (29) | 88 (39) | 20 (9) |
| Bleeding/hemorrhage | 13 (50) | 1 (4) | 2 (7) | 0 | 121 (55) | 4 (2) | 59 (26) | 4 (2) |
| Liver injury/failure | 13 (50) | 0 | 15 (50) | 1 (3) | 140 (63) | 31 (14) | 120 (53) | 28 (12) |
| Proteinuria | 9 (35) | 1 (4) | 2 (7) | 0 | 76 (34) | 6 (3) | 19 (8) | 0 |
| Hypertension | 7 (27) | 3 (12) | 2 (7) | 2 (7) | 100 (45) | 52 (24) | 27 (12) | 12 (5) |
| Gastrointestinal hemorrhage | 3 (12) | 1 (4) | 0 | 0 | 23 (10) | 3 (<1) | 6 (3) | 1 (<1) |
| Pulmonary hemorrhage | 2 (8) | 0 | 1 (3) | 0 | 15 (7) | 1 (<1) | 4 (2) | 1 (<1) |
| Other TEAE of interest | ||||||||
| ILD including pneumonitis | 0 | 0 | 1 (3) | 1 (3) | 3 (1) | 1 (<1) | 4 (2) | 2 (<1) |
aData published in Nakagawa et al. 2019 [20]
bMost common defined as occurring in ≥ 30% of patients in any treatment arm
cMost common defined as occurring in ≥ 2 patients in either treatment arm (Taiwanese subgroup)
dIn all three cases the SAE was considered not related to study drug
eMost common defined as occurring in ≥ 5% of either treatment arm (Taiwanese subgroup)
AE adverse event, ERL erlotinib, ILD interstitial disease, NR not reported, PBO placebo, RAM ramucirumab, SAE serious adverse event, TEAE treatment-emergent adverse event, TE-AESI treatment-emergent adverse event of special interest, TE-SAE treatment-emergent serious adverse event