Table 4 Overview of the safety profile of IRd (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) |
Any TEAE | 137 (97.9) | 79 (97.5) | 58 (98.3) | 52 (96.3) | 85 (98.8) |
Treatment-related | 115 (82.1) | 69 (85.2) | 46 (78.0) | 47 (87.0) | 68 (79.1) |
Grade ≥3 TEAEs | 96 (68.6) | 56 (69.1) | 40 (67.8) | 33 (61.1) | 63 (73.3) |
Treatment-related | 52 (37.1) | 27 (33.3) | 25 (42.4) | 19 (35.2) | 33 (38.4) |
Serious TEAEs | 62 (44.3) | 34 (42.0) | 28 (47.5) | 21 (38.9) | 41 (47.7) |
Treatment-related | 18 (12.9) | 10 (12.3) | 8 (13.6) | 8 (14.8) | 10 (11.6) |
TEAE leading to drug modificationa | 93 (66.4) | 54 (66.7) | 39 (66.1) | 33 (61.1) | 60 (69.8) |
TEAE leading to drug discontinuationa | 28 (20.0) | 16 (19.8) | 12 (20.3) | 14 (25.9) | 14 (16.3) |
On-study deathsb | 4 (2.9) | 2 (2.5) | 2 (3.4) | 1 (1.9) | 3 (3.5) |