Table 5 Most commonly occurring treatment emergent adverse eventsa (safety population; N = 140).
Age | Frailty status | ||||
---|---|---|---|---|---|
TEAEs, n (%) | Overall (N = 140) | <75 years (n = 81) | ≥75 years (n = 59) | Non-frail (n = 54) | Frail (n = 86) |
Diarrhea | 71 (50.7) | 40 (49.4) | 31 (52.5) | 27 (50.0) | 44 (51.2) |
Grade 1–2 | 58 (41.4) | 34 (42.0) | 24 (40.7) | 20 (37.0) | 38 (44.2) |
Grade ≥3 | 13 (9.3) | 6 (7.4) | 7 (11.9) | 7 (13.0) | 6 (7.0) |
PN | 39 (27.9) | 24 (29.6) | 15 (25.4) | 12 (22.2) | 27 (31.4) |
Grade 1–2 | 36 (25.7) | 22 (27.2) | 14 (23.7) | 10 (18.5) | 26 (30.2) |
Grade ≥3 | 3 (2.1) | 2 (2.5) | 1 (1.7) | 2 (3.7) | 1 (1.2) |
Fatigue | 47 (33.6) | 29 (35.8) | 18 (30.5) | 15 (27.8) | 32 (37.2) |
Grade 1─2 | 42 (30.0) | 27 (33.3) | 15 (25.4) | 12 (22.2) | 30 (34.9) |
Grade ≥3 | 5 (3.6) | 2 (2.5) | 3 (5.1) | 3 (5.6) | 2 (2.3) |
Nausea | 35 (25.0) | 23 (28.4) | 12 (20.3) | 11 (20.4) | 24 (27.9) |
Grade 1–2 | 31 (22.1) | 22 (27.2) | 9 (15.3) | 11 (20.4) | 20 (23.3) |
Grade ≥3 | 4 (2.9) | 1 (1.2) | 3 (5.1) | 0 | 4 (4.7) |
Peripheral edema | 36 (25.7) | 23 (28.4) | 13 (22.0) | 14 (25.9) | 22 (25.6) |
Grade 1–2 | 35 (25.0) | 23 (28.4) | 12 (20.3) | 14 (25.9) | 21 (24.4) |
Grade ≥3 | 1 (0.7) | 0 | 1 (1.7) | 0 | 1 (1.2) |
Arthralgia | 31 (22.1) | 21 (25.9) | 10 (16.9) | 11 (20.4) | 20 (23.3) |
Grade 1–2 | 28 (20.0) | 19 (23.5) | 9 (15.3) | 10 (18.5) | 18 (20.9) |
Grade ≥3 | 3 (2.1) | 2 (2.5) | 1 (1.7) | 1 (1.9) | 2 (2.3) |
Back pain | 26 (18.6) | 17 (21.0) | 9 (15.3) | 8 (14.8) | 18 (20.9) |
Grade 1–2 | 23 (16.4) | 15 (18.5) | 8 (13.6) | 8 (14.8) | 15 (17.4) |
Grade ≥3 | 3 (2.1) | 2 (2.5) | 1 (1.7) | 0 | 3 (3.5) |
Constipation | 24 (17.1) | 12 (14.8) | 12 (20.3) | 7 (13.0) | 17 (19.8) |
Grade 1–2 | 24 (17.1) | 12 (14.8) | 12 (20.3) | 7 (13.0) | 17 (19.8) |
Grade ≥3 | 0 | 0 | 0 | 0 | 0 |
Hypokalemia | 25 (17.9) | 12 (14.8)b | 13 (22.0) | 3 (5.6) | 22 (25.6)b |
Grade 1–2 | 19 (13.6) | 10 (12.3) | 9 (15.3) | 2 (3.7) | 17 (19.8) |
Grade ≥3 | 6 (4.3) | 2 (2.5) | 4 (6.8) | 1 (1.9) | 5 (5.8) |
Rash | 24 (17.1) | 14 (17.3) | 10 (16.9) | 7 (13.0) | 17 (19.8) |
Grade 1–2 | 20 (14.3) | 11 (13.6) | 9 (15.3) | 6 (11.1) | 14 (16.3) |
Grade ≥3 | 4 (2.9) | 3 (3.7) | 1 (1.7) | 1 (1.9) | 3 (3.5) |
Pneumonia | 18 (12.9) | 10 (12.3) | 8 (13.6) | 6 (11.1) | 12 (14.0) |
Grade 1–2 | 9 (6.4) | 7 (8.6) | 2 (3.4) | 5 (9.3) | 4 (4.7) |
Grade ≥3 | 9 (6.4) | 3 (3.7) | 6 (10.2) | 1 (1.9) | 8 (9.3) |