Patients with at least one event, n (%) | Stratum 1 (n = 16) | Stratum 2 (n = 8) | Stratum 3 (n = 2) | Overall (n = 26) |
---|---|---|---|---|
TEAE | 16 (100.0) | 8 (100.0) | 2 (100.0) | 26 (100.0) |
BI1361849- and/or radiation-related AE | 16 (100.0) | 8 (100.0) | 2 (100.0) | 26 (100.0) |
TEAE related to BI1361849 | 15 (93.8) | 8 (100.0) | 2 (100.0) | 25 (96.2) |
TEAE related to radiation | 4 (25.0) | 1 (12.5) | 0 (50.0) | 5 (19.2) |
Serious TEAE | 7 (43.8) | 3 (37.5) | 1 (50.0) | 11 (42.3) |
Serious BI1361849- and/or radiation-related AE | 1 (6.3) | 0 | 0 | 1 (3.8) |
Related to BI1361849 | 0 | 0 | 0 | 0 |
Related to radiation | 1 (6.3) | 0 | 0 | 1 (3.8) |
TEAE toxicity grade ≥ 3a | 9 (56.3) | 4 (50.0) | 2 (100.0) | 15 (57.7) |
BI1361849- and/or radiation-related AE toxicity grade ≥ 3a | 2 (12.5) | 1 (12.5) | 1 (50.0) | 4 (15.4) |
Related to BI1361849 | 1 (6.3) | 1 (12.5) | 1 (50.0) | 3 (11.5) |
Related related to radiation | 1 (6.3) | 0 | 0 | 1 (3.8) |
Serious BI1361849- and/or radiation-related AE toxicity grade ≥ 3a | 1 (6.3) | 0 | 0 | 1 (3.8) |
Related to BI1361849 | 0 | 0 | 0 | 0 |
Related to radiation | 1 (6.3) | 0 | 0 | 1 (3.8) |
TEAE leading to discontinuation | 4 (25.0) | 0 | 0 | 4 (15.4) |
TEAE toxicity grade ≥ 3 leading to discontinuation | 2 (12.5) | 0 | 0 | 2 (7.7) |
TEAE leading to interruption/dose modification | 4 (25.0) | 0 | 0 | 4 (15.4) |
TEAE leading to death | 0 | 0 | 0 | 0 |