Table 2.
Overview of AEs
| Feladilimab mg/tremelimumab mg | ||||||
|---|---|---|---|---|---|---|
| Category, n (%) | 8/75 (N = 1) | 24/75 (N = 1) | 8/225 (N = 5) | 80/75 (N = 3) | 24/225 (N = 16) | Total (N = 26) |
| Any AE | 1 (100) | 1 (100) | 5 (100) | 3 (100) | 16 (100) | 26 (100) |
| TR-AEsa | 1 (100) | 0 | 4 (80) | 2 (67) | 12 (75) | 19 (73) |
| AEs leading to permanent discontinuation of study treatmentb | 0 | 0 | 1 (20) | 0 | 3 (19) | 4 (15) |
| AEs leading to dose interruption/delay of study treatment | 0 | 0 | 3 (60) | 0 | 4 (25) | 7 (27) |
| Any SAE | 0 | 0 | 3 (60) | 3 (100) | 6 (38) | 12 (46) |
| TR-SAEsc | 0 | 0 | 0 | 0 | 2 (13) | 2 (8) |
| SAEs leading to permanent discontinuation of study treatment | 0 | 0 | 1 (20) | 0 | 2 (13) | 3 (12) |
| SAEs leading to dose reduction | 0 | 0 | 0 | 0 | 0 | 0 |
| SAEs leading to dose interruption/delay of study treatment | 0 | 0 | 1 (20) | 0 | 1 (6) | 2 (8) |
| Fatal SAEs | 0 | 0 | 0 | 0 | 1 (6) | 1 (4) |
For patients receiving combination therapy, “study treatment” refers to feladilimab and/or tremelimumab. A worst-case approach was taken for patients with missing relatedness data; events with missing relatedness were assumed to be treatment related. aThe two most common TR-AEs were diarrhea (35%) and fatigue (31%); bprogressive disease and AEs were reported in two patients. However, in the study treatment discontinuation form, the reason reported was progressive disease; cTR-SAEs experienced were diarrhea and colitis
AE adverse event, SAE serious adverse event, TR treatment related