TABLE A2.
TEAEs by Treatment Arm
| Description | Arm A (ramucirumab + osimertinib), No. (%) | Arm B (osimertinib), No. (%) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| G1 | G2 | G3 | G4 | Any Grade | G1 | G2 | G3 | Any Grade | |
| Diarrhea | 52 (55.9) | 11 (11.8) | 3 (3.2) | 0 | 66 (71.0) | 25 (54.4) | 5 (10.9) | 0 | 30 (65.2) |
| Skin rash | 46 (49.5) | 10 (10.8) | 1 (1.1) | 0 | 57 (61.3) | 25 (54.4) | 1 (2.2) | 1 (2.2) | 27 (58.7) |
| Fatigue | 42 (45.2) | 10 (10.8) | 3 (3.2) | 0 | 55 (59.1) | 15 (32.6) | 4 (8.7) | 0 | 19 (41.3) |
| Headache | 37 (39.8) | 9 (9.7) | 0 | 0 | 46 (49.5) | 7 (15.2) | 1 (2.2) | 0 | 8 (17.4) |
| Cough | 36 (38.7) | 10 (10.8) | 0 | 0 | 46 (49.5) | 8 (17.4) | 2 (4.4) | 0 | 10 (21.7) |
| Epistaxis | 38 (40.9) | 3 (3.2) | 0 | 0 | 41 (44.1) | 3 (6.5) | 0 | 0 | 3 (6.5) |
| Paronychia | 30 (32.3) | 8 (8.6) | 0 | 0 | 38 (40.9) | 13 (28.3) | 0 | 0 | 14 (30.4) |
| Anorexia | 24 (25.8) | 10 (10.8) | 0 | 0 | 34 (36.6) | 3 (6.5) | 1 (2.2) | 1 (2.2) | 5 (10.9) |
| Hypertension | 3 (3.2) | 10 (10.8) | 21 (22.6) | 0 | 34 (36.6) | 1 (2.2) | 4 (8.7) | 1 (2.2) | 6 (13.0) |
| Platelet count decreased | 22 (23.7) | 11 (11.8) | 1 (1.1) | 0 | 34 (36.6) | 7 (15.2) | 0 | 1 (2.2) | 8 (17.4) |
| Dry skin | 30 (32.3) | 2 (2.2) | 0 | 0 | 32 (34.4) | 11 (23.9) | 1 (2.2) | 0 | 12 (26.1) |
| Nausea | 28 (30.1) | 4 (4.3) | 0 | 0 | 32 (34.4) | 6 (13.0) | 1 (2.2) | 0 | 7 (15.2) |
| Alopecia | 25 (26.9) | 3 (3.2) | 0 | 0 | 28 (30.1) | 10 (21.7) | 0 | 0 | 10 (21.7) |
| Anemia | 21 (22.6) | 2 (2.2) | 3 (3.2) | 0 | 26 (28.0) | 6 (13.0) | 1 (2.2) | 2 (4.4) | 9 (19.6) |
| Pain in extremity | 19 (20.4) | 7 (7.5) | 0 | 0 | 26 (28.0) | 5 (10.9) | 2 (4.4) | 0 | 7 (15.2) |
| Back pain | 15 (16.1) | 8 (8.6) | 2 (2.2) | 0 | 25 (26.9) | 8 (17.4) | 1 (2.2) | 0 | 9 (19.6) |
| Dyspnea | 16 (17.2) | 7(7.5) | 1 (1.1) | 0 | 24 (25.8) | 4 (8.7) | 5 (10.9) | 1 (2.2) | 10 (21.7) |
| WBC decreased | 19 (20.4) | 5 (5.4) | 0 | 0 | 24 (25.8) | 3 (6.5) | 2 (4.4) | 0 | 5 (10.9) |
| Pruritus | 22 (23.7) | 2 (2.2) | 0 | 0 | 24 (25.8) | 3 (6.5) | 0 | 1 (2.2) | 4 (8.7) |
| Vomiting | 19 (20.4) | 5 (5.4) | 0 | 0 | 24 (25.8) | 2 (4.4) | 1 (2.2) | 0 | 3 (6.5) |
| Hyponatremia | 13 (14.0) | 4 (4.3) | 2 (2.2) | 1 (1.1) | 20 (21.5) | 7 (15.2) | 0 | 1 (2.2) | 8 (17.4) |
| Proteinuria | 5 (5.4) | 11 (11.8) | 2 (2.2) | 0 | 18 (19.4) | 0 | 1 (2.2) | 0 | 1 (2.2) |
Abbreviations: G, grade; TEAEs, treatment-emergent adverse events.