Table 3.
MEDI7247-related adverse events of severity grade 3/4 by system organ class and preferred term in ≥ 5% of patients in any group, as-treated population
| System organ class and preferred termb | AML (n = 27) | MM (n = 18) | DLBCL (n = 22) | Total (N = 67) | ||||
|---|---|---|---|---|---|---|---|---|
| All grades | Grades 3/4a | All grades | Grades 3/4a | All grades | Grades 3/4a | All grades | Grades 3/4a | |
| Blood and lymphatic system disorders | ||||||||
| Anemia | 3 (11.1) | 3 (11.1) | 6 (33.3) | 5 (27.8) | 10 (45.5) | 7 (31.8) | 19 (28.4) | 15 (22.4) |
| Febrile neutropenia | 3 (11.1) | 3 (11.1) | 2 (11.1) | 2 (11.1) | 2 (9.1) | 2 (9.1) | 7 (10.4) | 7 (10.4) |
| Leukopenia | 1 (3.7) | 1 (3.7) | 1 (5.6) | 1 (5.6) | 0 | 0 | 2 (3.0) | 2 (3.0) |
| Neutropenia | 2 (7.4) | 2 (7.4) | 11 (61.1) | 11 (61.1) | 11 (50.0) | 10 (45.5) | 24 (35.8) | 23 (34.3) |
| Thrombocytopenia | 5 (18.5) | 5 (18.5) | 11 (61.1) | 9 (50.0) | 12 (54.5) | 12 (54.5) | 28 (41.8) | 26 (38.8) |
| Investigations | ||||||||
| Electrocardiogram QT prolonged | 0 | 0 | 0 | 0 | 2 (9.1) | 1 (4.5) | 2 (3.0) | 1 (1.5) |
| GGT increased | 0 | 0 | 1 (5.6) | 0 | 1 (4.5) | 1 (4.5) | 2 (3.0) | 1 (1.5) |
| Lipase increased | 0 | 0 | 0 | 0 | 1 (4.5) | 1 (4.5) | 1 (1.5) | 1 (1.5) |
| Neutrophil count decreased | 0 | 0 | 1 (5.6) | 1 (5.6) | 3 (13.6) | 3 (13.6) | 4 (6.0) | 4 (6.0) |
| Platelet count decreased | 0 | 0 | 0 | 0 | 2 (9.1) | 1 (4.5) | 2 (3.0) | 1 (1.5) |
| White blood cell count decreased | 0 | 0 | 0 | 0 | 2 (9.1) | 2 (9.1) | 2 (3.0) | 2 (3.0) |
| Reproductive system and breast disorders | ||||||||
| Prostatitis | 0 | 0 | 1 (5.6) | 1 (5.6) | 0 | 0 | 1 (1.5) | 1 (1.5) |
| Respiratory, thoracic, and mediastinal disorders | ||||||||
| Dyspnea | 1 (3.7) | 0 | 2 (11.1) | 1 (5.6) | 0 | 0 | 3 (4.5) | 1 (1.5) |
| Skin and subcutaneous tissue disorders | ||||||||
| Blister | 0 | 0 | 1 (5.6) | 1 (5.6) | 1 (4.5) | 0 | 2 (3.0) | 1 (1.5) |
| Rash | 0 | 0 | 3 (16.7) | 1 (5.6) | 1 (4.5) | 0 | 4 (6.0) | 1 (1.5) |
| Rash maculo-papular | 1 (3.7) | 0 | 2 (11.1) | 0 | 1 (4.5) | 1 (4.5) | 4 (6.0) | 1 (1.5) |
| Rash popular | 0 | 0 | 1 (5.6) | 1 (5.6) | 0 | 0 | 1 (1.5) | 1 (1.5) |
Data are presented as n (%)
AML acute myeloid leukemia, DLBCL diffuse large B-cell lymphoma, GGT gamma-glutamyltransferase, MedDRA Medical Dictionary for Regulatory Activities, MM multiple myeloma
aGrade 3–4 events include grade 3 (Severe) and grade 4 (Life Threatening)
bPatients are counted once for each System Organ Class and Preferred Term (MedDRA v22.1) regardless of the number of events