Safety profile
| . | HCT (n = 14) . | SOT (n = 12) . | All (N = 26) . |
|---|---|---|---|
| All TEAEs | 14 (100) | 12 (100) | 26 (100) |
| Grade ≥3 TEAEs | 12 (85.7) | 7 (58.3) | 19 (73.1) |
| TEAEs leading to study discontinuation | 4 (28.6) | 4 (33.3) | 8 (30.8) |
| All TR-TEAEs | 4 (28.6) | 5 (41.7) | 9 (34.6) |
| Grade ≥3 TR-TEAEs | 2 (14.3) | 2 (16.7) | 4 (15.4) |
| TR-TEAEs leading to study discontinuation | 0 | 1 (8.3) | 1 (3.8) |
| All TESAEs | 9 (64.3) | 8 (66.7) | 17 (65.4) |
| Grade ≥3 TESAEs | 9 (64.3) | 7 (58.3) | 16 (61.5) |
| Fatal TESAEs | 4 (28.6) | 1 (8.3) | 5 (19.2)∗ |
| All TR-TESAEs | 1 (7.1) | 2 (16.7) | 3 (11.5) |
| Grade ≥3 TR-TESAEs | 1 (7.1) | 2 (16.7) | 3 (11.5) |
| Fatal TR-TESAEs | 0 | 0 | 0 |
| . | HCT (n = 14) . | SOT (n = 12) . | All (N = 26) . |
|---|---|---|---|
| All TEAEs | 14 (100) | 12 (100) | 26 (100) |
| Grade ≥3 TEAEs | 12 (85.7) | 7 (58.3) | 19 (73.1) |
| TEAEs leading to study discontinuation | 4 (28.6) | 4 (33.3) | 8 (30.8) |
| All TR-TEAEs | 4 (28.6) | 5 (41.7) | 9 (34.6) |
| Grade ≥3 TR-TEAEs | 2 (14.3) | 2 (16.7) | 4 (15.4) |
| TR-TEAEs leading to study discontinuation | 0 | 1 (8.3) | 1 (3.8) |
| All TESAEs | 9 (64.3) | 8 (66.7) | 17 (65.4) |
| Grade ≥3 TESAEs | 9 (64.3) | 7 (58.3) | 16 (61.5) |
| Fatal TESAEs | 4 (28.6) | 1 (8.3) | 5 (19.2)∗ |
| All TR-TESAEs | 1 (7.1) | 2 (16.7) | 3 (11.5) |
| Grade ≥3 TR-TESAEs | 1 (7.1) | 2 (16.7) | 3 (11.5) |
| Fatal TR-TESAEs | 0 | 0 | 0 |
Data are given as number (%).
TR-TEAE, treatment-related TEAE; TR-TESAE, treatment-related TESAE.
Three of 5 deaths were due to disease progression (1 in a pediatric patient); 1 was due to cardiac arrest, and 1 was due to multiple organ dysfunction syndrome. Deaths due to other causes (eg, other than fatal TESAEs) occurred in 2 additional patients (1 with diffuse alveolar hemorrhage and hypoxic respiratory failure, and 1 with disease progression).