Table 3.
TEAEs and AEs of Special Interest for RAM (Japanese Safety Population)
| Event | RAM + ERL (N = 105) |
PL + ERL (N = 105) |
||
|---|---|---|---|---|
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| ≥1 TEAE | 105 (100.0) | 81 (77.1) | 105 (100.0) | 64 (61.0) |
| TEAEs occurring in >40% of patients treated with RAM + ERL | ||||
| Dermatitis acneiform | 96 (91.4) | 25 (23.8) | 95 (90.5) | 11 (10.5) |
| Diarrhea | 78 (74.3) | 7 (6.7) | 77 (73.3) | 2 (1.9) |
| Paronychia | 73 (69.5) | 7 (6.7) | 66 (62.9) | 5 (4.8) |
| Increased ALT | 68 (64.8) | 14 (13.3) | 50 (47.6) | 15 (14.3) |
| Increased AST | 66 (62.9) | 6 (5.7) | 45 (42.9) | 8 (7.6) |
| Stomatitis | 59 (56.2) | 1 (1.0) | 41 (39.0) | 2 (1.9) |
| Hypertension | 55 (52.4) | 26 (24.8) | 17 (16.2) | 5 (4.8) |
| Dry skin | 48 (45.7) | 1 (1.0) | 46 (43.8) | 3 (2.9) |
| Proteinuria | 47 (44.8) | 3 (2.9) | 11 (10.5) | 0 (0.0) |
| Epistaxis | 47 (44.8) | 0 (0.0) | 19 (18.1) | 0 (0.0) |
| Alopecia | 45 (42.9) | 0 (0.0) | 18 (17.1) | 0 (0.0) |
| AEs of special interesta | ||||
| Bleeding or hemorrhage | 66 (62.9) | 1 (1.0) | 41 (39.0) | 2 (1.9) |
| Epistaxis | 47 (44.8) | 0 (0.0) | 19 (18.1) | 0 (0.0) |
| Hematuria | 8 (7.6) | 0 (0.0) | 6 (5.7) | 2 (1.9) |
| Purpura | 8 (7.6) | 0 (0.0) | 5 (4.8) | 0 (0.0) |
| Gingival bleeding | 7 (6.7) | 0 (0.0) | 1 (1.0) | 0 (0.0) |
| GI hemorrhageb | 12 (11.4) | 1 (1.0) | 4 (3.8) | 0 (0.0) |
| Hypertension | 55 (52.4) | 26 (24.8) | 17 (16.2) | 5 (4.8) |
| Proteinuriac | 48 (45.7) | 3 (2.9) | 11 (10.5) | 0 (0.0) |
| Liver injury or liver failure and liver infection | 86 (81.9) | 20 (19.0) | 78 (74.3) | 22 (21.0) |
| Increased ALT | 68 (64.8) | 14 (13.3) | 50 (47.6) | 15 (14.3) |
| Increased AST | 66 (62.9) | 6 (5.7) | 45 (42.9) | 8 (7.6) |
| Increased blood bilirubin | 40 (38.1) | 2 (1.9) | 43 (41.0) | 0 (0.0) |
| Increased GGT | 7 (6.7) | 2 (1.9) | 6 (5.7) | 0 (0.0) |
| Abnormal hepatic function | 7 (6.7) | 4 (3.8) | 6 (5.7) | 3 (2.9) |
| Infusion-related reactions | 2 (1.9) | 0 (0.0) | 1 (1.0) | 0 (0.0) |
| Other TEAE of interest | ||||
| ILD | 1 (1.0) | 1 (1.0) | 3 (2.9) | 2 (1.9) |
| Pneumonitis | 0 (0.0) | 0 (0.0) | 2 (1.9) | 0 (0.0) |
Note: Data are n (%).
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ERL, erlotinib; GGT, gamma-glutamyltransferase; GI, gastrointestinal; ILD, interstitial lung disease; PL, placebo; RAM, ramucirumab; TEAE, treatment-emergent adverse event; VEGF, vascular endothelial growth factor.
AEs of special interest are prespecified selected AEs of clinical interest that have been associated with other antiangiogenic agents, in a similar pharmacologic class as ramucirumab, that inhibit the VEGF signaling pathway.
Includes the preferred terms hemorrhoidal hemorrhage, anal hemorrhage, small intestinal hemorrhage, lower gastrointestinal hemorrhage, and hematochezia.
Includes the preferred terms proteinuria and protein urine present.