Summary of TEAEs
| . | Cohort 1 (ENKTL) (n = 22) n (%) . | Cohort 2 (PTCLs) (n = 44) n (%) . | Cohort 3 (MF or SS) (n = 11) n (%) . | Total (N = 77) n (%) . |
|---|---|---|---|---|
| Patients with ≥1 TEAE | 22 (100.0) | 41 (93.2) | 10 (90.9) | 73 (94.8) |
| Grade ≥3 TEAE | 13 (59.1) | 25 (56.8) | 8 (72.7) | 46 (59.7) |
| Grade ≥3 TEAE in ≥3 patients based on preferred term | ||||
| Anemia | 3 (13.6) | 3 (6.8) | 0 (0.0) | 6 (7.8) |
| Pneumonia | 2 (9.1) | 3 (6.8) | 0 (0.0) | 5 (6.5) |
| Neutropenia | 0 (0.0) | 4 (9.1) | 0 (0.0) | 4 (5.2) |
| Neutrophil count decreased | 3 (13.6) | 0 (0.0) | 0 (0.0) | 3 (3.9) |
| Thrombocytopenia | 0 (0.0) | 3 (6.8) | 0 (0.0) | 3 (3.9) |
| White blood cell count decreased | 2 (9.1) | 1 (2.3) | 0 (0.0) | 3 (3.9) |
| Patients with ≥1 TRAE | 17 (77.3) | 33 (75.0) | 7 (63.6) | 57 (74.0) |
| Grade ≥3 TRAE | 7 (31.8) | 10 (22.7) | 0 (0.0) | 17 (22.1) |
| Grade ≥3 TRAE in ≥2 patients by preferred term | ||||
| Anemia | 2 (9.1) | 1 (2.3) | 0 (0.0) | 3 (3.9) |
| Pneumonia | 2 (9.1) | 1 (2.3) | 0 (0.0) | 3 (3.9) |
| Neutrophil count decreased | 3 (13.6) | 0 (0.0) | 0 (0.0) | 3 (3.9) |
| White blood cell count decreased | 2 (9.1) | 1 (2.3) | 0 (0.0) | 3 (3.9) |
| Platelet count decreased | 1 (4.5) | 1 (2.3) | 0 (0.0) | 2 (2.6) |
| Pyrexia | 0 (0.0) | 2 (4.5) | 0 (0.0) | 2 (2.6) |
| irAE | 6 (27.3) | 13 (29.5) | 3 (27.3) | 22 (28.6) |
| Grade ≥3 irAE | 2 (9.1) | 2 (4.5) | 0 (0.0) | 4 (5.2) |
| Grade ≥3 irAE based on preferred term | ||||
| Hepatitis | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.3) |
| Hypothyroidism | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (1.3) |
| Blood creatine phosphokinase increased | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (1.3) |
| Rash | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.3) |
| Urticaria | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.3) |
| IRR | 5 (22.7) | 7 (15.9) | 2 (18.2) | 14 (18.2) |
| Grade ≥3 IRR | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.3) |
| . | Cohort 1 (ENKTL) (n = 22) n (%) . | Cohort 2 (PTCLs) (n = 44) n (%) . | Cohort 3 (MF or SS) (n = 11) n (%) . | Total (N = 77) n (%) . |
|---|---|---|---|---|
| Patients with ≥1 TEAE | 22 (100.0) | 41 (93.2) | 10 (90.9) | 73 (94.8) |
| Grade ≥3 TEAE | 13 (59.1) | 25 (56.8) | 8 (72.7) | 46 (59.7) |
| Grade ≥3 TEAE in ≥3 patients based on preferred term | ||||
| Anemia | 3 (13.6) | 3 (6.8) | 0 (0.0) | 6 (7.8) |
| Pneumonia | 2 (9.1) | 3 (6.8) | 0 (0.0) | 5 (6.5) |
| Neutropenia | 0 (0.0) | 4 (9.1) | 0 (0.0) | 4 (5.2) |
| Neutrophil count decreased | 3 (13.6) | 0 (0.0) | 0 (0.0) | 3 (3.9) |
| Thrombocytopenia | 0 (0.0) | 3 (6.8) | 0 (0.0) | 3 (3.9) |
| White blood cell count decreased | 2 (9.1) | 1 (2.3) | 0 (0.0) | 3 (3.9) |
| Patients with ≥1 TRAE | 17 (77.3) | 33 (75.0) | 7 (63.6) | 57 (74.0) |
| Grade ≥3 TRAE | 7 (31.8) | 10 (22.7) | 0 (0.0) | 17 (22.1) |
| Grade ≥3 TRAE in ≥2 patients by preferred term | ||||
| Anemia | 2 (9.1) | 1 (2.3) | 0 (0.0) | 3 (3.9) |
| Pneumonia | 2 (9.1) | 1 (2.3) | 0 (0.0) | 3 (3.9) |
| Neutrophil count decreased | 3 (13.6) | 0 (0.0) | 0 (0.0) | 3 (3.9) |
| White blood cell count decreased | 2 (9.1) | 1 (2.3) | 0 (0.0) | 3 (3.9) |
| Platelet count decreased | 1 (4.5) | 1 (2.3) | 0 (0.0) | 2 (2.6) |
| Pyrexia | 0 (0.0) | 2 (4.5) | 0 (0.0) | 2 (2.6) |
| irAE | 6 (27.3) | 13 (29.5) | 3 (27.3) | 22 (28.6) |
| Grade ≥3 irAE | 2 (9.1) | 2 (4.5) | 0 (0.0) | 4 (5.2) |
| Grade ≥3 irAE based on preferred term | ||||
| Hepatitis | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.3) |
| Hypothyroidism | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (1.3) |
| Blood creatine phosphokinase increased | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (1.3) |
| Rash | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.3) |
| Urticaria | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.3) |
| IRR | 5 (22.7) | 7 (15.9) | 2 (18.2) | 14 (18.2) |
| Grade ≥3 IRR | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (1.3) |
TEAE was defined as an AE that had an onset date or a worsening in severity from baseline (pretreatment) or on or after the first dose of study drug up to 30 days after study drug discontinuation or initiation of a new anticancer therapy.
TEAEs also included all irAEs and drug-related serious AEs recorded up to 90 days after the last dose of study drug, regardless of whether or not the patient started a new anticancer therapy.
The worsening of an AE to grade 5 beyond day 30 after the last dose of study treatment was also considered a TEAE (if it occurred before the start of a new anticancer therapy). TRAEs included those events considered by the investigator to be related to drug treatment or with missing assessment of the causal relationship.
Patients with multiple events for a given preferred term are counted only once for each preferred term.