Table 6.
Grade 3 or higher TEAEs in the safety analysis set
| Ixazomib + LenDex N = 34 n (%) |
|
|---|---|
| Neutropenia | 7 (21) |
| Platelet count decreased | 7 (21) |
| Neutrophil count decreased | 6 (18) |
| Diarrhea | 5 (15) |
| Maculopapular rash | 4 (12) |
| Erythema multiforme | 3 (9) |
| Pneumonia | 3 (9) |
| White blood cell count decreased | 3 (9) |
| Alanine aminotransferase increased | 1 (3) |
| Anemia | 1 (3) |
| Aspartate aminotransferase increased | 1 (3) |
| Blood creatine phosphokinase increased | 1 (3) |
| Cellulitis | 1 (3) |
| Fall | 1 (3) |
| Femoral neck fracture | 1 (3) |
| Hyperglycemia | 1 (3) |
| Hypertension | 1 (3) |
| Hypophosphatemia | 1 (3) |
| Hypotension | 1 (3) |
| Leukemia | 1 (3) |
| Lipase increased | 1 (3) |
| Loss of consciousness | 1 (3) |
| Lung neoplasm malignant | 1 (3) |
| Lymphocyte count decreased | 1 (3) |
| Malignant neoplasm of unknown primary setaa | 1 (3) |
| Edema peripheral | 1 (3) |
| Osteonecrosis of jaw | 1 (3) |
| Pharyngitis | 1 (3) |
| Pneumonitis | 1 (3) |
| Rash generalized | 1 (3) |
| Macular rash | 1 (3) |
| Sebaceous nevus | 1 (3) |
| Subarachnoid hemorrhage | 1 (3) |
| Subdural hemorrhage | 1 (3) |
| Thrombocytopenia | 1 (3) |
| Tooth infection | 1 (3) |
| Vomiting | 1 (3) |
Toxicity grade defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
LenDex lenalidomide and dexamethasone, TEAE treatment-emergent adverse event
aReported during the follow-up period