Table 2.
Treatment-emergent adverse events in the safety analysis set
| n (%) | N = 295 | |
|---|---|---|
| Any TEAEs | 249 (84.4) | |
| Grade ≥ 3 TEAEs | 171 (58.0) | |
| IRd treatment-related TEAEs | 223 (75.6) | |
| IRd treatment-related grade ≥ 3 TEAEs | 137 (46.4) | |
| ADRs | 211 (71.5) | |
| Grade ≥ 3 ADRs | 127 (43.1) | |
| Serious TEAEs | 96 (32.5) | |
| TEAEs leading to treatment discontinuation | 73 (24.7) | |
| TEAEs leading to deatha | 24 (8.1) | |
|
TEAEs occurring in ≥ 5.0% patients System organ class Preferred term |
Overall | Grade ≥ 3 |
| Blood and lymphatic system disorders | ||
| Anemia | 31 (10.5) | 22 (7.5) |
| Leukopeniab | 76 (25.8) | 35 (11.9) |
| Neutropeniac | 82 (27.8) | 48 (16.3) |
| Thrombocytopeniad | 85 (28.8) | 63 (21.4) |
| Gastrointestinal disorders | ||
| Diarrhea | 80 (27.1) | 16 (5.4) |
| Constipation | 20 (6.8) | - |
| Nausea | 18 (6.1) | - |
| Vomiting | 17 (5.8) | 2 (0.7) |
| Infections and infestations | ||
| Pneumonia | 26 (8.8) | 18 (6.1) |
| Nasopharyngitis | 16 (5.4) | - |
| Skin and subcutaneous tissue disorders | ||
| Rash | 40 (13.6) | 3 (1.0) |
ADR adverse drug reaction, IRd ixazomib + lenalidomide + dexamethasone, TEAE treatment-emergent adverse event
aTEAEs leading to death included plasma cell myeloma (n = 12; 4.1%), cardio-respiratory arrest, pneumonia, pneumonia influenza (n = 2; 0.7% each), and cardiac arrest, cardiac failure, cardiac death, death, multiple organ dysfunction syndrome, sepsis, acute kidney injury, interstitial lung disease, and pulmonary amyloidosis (n = 1; 0.3% each)
bIncludes leukopenia and white blood cell count decreased
cIncludes neutropenia and neutrophil count decreased
dIncludes thrombocytopenia and platelet count decreased