Incidence of TRAEs grade 3 or more and TEAEs leading to discontinuation in safety analysis set
| . | AITL (n = 38) . | PTCL-NOS∗ (n = 25) . | Total† (N = 65) . |
|---|---|---|---|
| Total number of grade ≥3 TRAEs | 114 | 66 | 182 |
| Patients with at least 1 grade ≥3 TRAE, n (%) | 26 (68.4) | 16 (64) | 43 (66.2) |
| Blood and lymphatic system disorders, n (%) | 22 (57.9) | 14 (56) | 37 (56.9) |
| Neutropenia | 11 (28.9) | 14 (56) | 25 (38.5) |
| Thrombocytopenia | 13 (34.2) | 8 (32) | 21 (32.3) |
| Anemia | 10 (26.3) | 4 (16) | 14 (21.5) |
| Leukopenia | 4 (10.5) | 6 (24) | 11 (16.9) |
| Febrile neutropenia | 4 (10.5) | 5 (20) | 10 (15.4) |
| Total number of TEAEs leading to permanent study drug discontinuation (%) | 11 | 12 | 23 |
| Patients with at least 1 TEAE leading to permanent study drug discontinuation | 9 (23.7) | 4 (16) | 13 (20.0) |
| Blood and lymphatic system disorders | 3 (7.9) | 3 (12) | 6 (9.2) |
| Anemia | 1 (2.6) | 1 (4) | 2 (3.1) |
| Thrombocytopenia | 1 (2.6) | 1 (4) | 2 (3.1) |
| Cytopenia | 0 | 1 (4) | 1 (1.5) |
| Hemolytic anemia | 1 (2.6) | 0 | 1 (1.5) |
| Histiocytosis hematophagic | 0 | 1 (4) | 1 (1.5) |
| Pancytopenia | 1 (2.6) | 0 | 1 (1.5) |
| Total number TRAEs leading to permanent study drug discontinuation | |||
| Patients with at least 1 TRAE leading to permanent study drug discontinuation | 4 (10.5) | 1 (4) | 5 (7.7) |
| Blood and lymphatic system disorders | 2 (5.3) | 0 | 2 (3.1) |
| Anemia | 1 (2.6) | 0 | 1 (1.5) |
| Pancytopenia | 1 (2.6) | 0 | 1 (1.5) |
| . | AITL (n = 38) . | PTCL-NOS∗ (n = 25) . | Total† (N = 65) . |
|---|---|---|---|
| Total number of grade ≥3 TRAEs | 114 | 66 | 182 |
| Patients with at least 1 grade ≥3 TRAE, n (%) | 26 (68.4) | 16 (64) | 43 (66.2) |
| Blood and lymphatic system disorders, n (%) | 22 (57.9) | 14 (56) | 37 (56.9) |
| Neutropenia | 11 (28.9) | 14 (56) | 25 (38.5) |
| Thrombocytopenia | 13 (34.2) | 8 (32) | 21 (32.3) |
| Anemia | 10 (26.3) | 4 (16) | 14 (21.5) |
| Leukopenia | 4 (10.5) | 6 (24) | 11 (16.9) |
| Febrile neutropenia | 4 (10.5) | 5 (20) | 10 (15.4) |
| Total number of TEAEs leading to permanent study drug discontinuation (%) | 11 | 12 | 23 |
| Patients with at least 1 TEAE leading to permanent study drug discontinuation | 9 (23.7) | 4 (16) | 13 (20.0) |
| Blood and lymphatic system disorders | 3 (7.9) | 3 (12) | 6 (9.2) |
| Anemia | 1 (2.6) | 1 (4) | 2 (3.1) |
| Thrombocytopenia | 1 (2.6) | 1 (4) | 2 (3.1) |
| Cytopenia | 0 | 1 (4) | 1 (1.5) |
| Hemolytic anemia | 1 (2.6) | 0 | 1 (1.5) |
| Histiocytosis hematophagic | 0 | 1 (4) | 1 (1.5) |
| Pancytopenia | 1 (2.6) | 0 | 1 (1.5) |
| Total number TRAEs leading to permanent study drug discontinuation | |||
| Patients with at least 1 TRAE leading to permanent study drug discontinuation | 4 (10.5) | 1 (4) | 5 (7.7) |
| Blood and lymphatic system disorders | 2 (5.3) | 0 | 2 (3.1) |
| Anemia | 1 (2.6) | 0 | 1 (1.5) |
| Pancytopenia | 1 (2.6) | 0 | 1 (1.5) |
ALK, anaplastic lymphoma kinase; TEAE, treatment-emergent adverse event; other cohorts, other includes ALCL ALK-negative and PTCL-subtype not specified per protocol.
PTCL-NOS = includes all patients regardless of CXCL12 status.
Total = 38 AITL + 25 PTCL-NOS + 2 “other” (ALCL ALK-negative and PTCL-subtype not specified per protocol).