Table 3.
Induction Treatment-Related Non-Hematologic Toxicity
| Adverse Event Type^ | Treatment Arm | |||||
|---|---|---|---|---|---|---|
| VRd (n=527) | KRd (n=526) | |||||
| Grade | Grade | |||||
| 3 | 4 | 5 | 3 | 4 | 5 | |
| Febrile neutropenia | 2 (<1%) | 1 (<1%) | - | 5 (1%) | 1 (<1%) | - |
| Atrial fibrillation | 2 (<1%) | - | - | 7 (1%) | - | - |
| Heart failure | 6 (1%) | - | - | 14 (3%) | 5 (1%) | - |
| Myocardial infarction | 1 (<1%) | - | 1 (<1%) | 3 (1%) | 1 (<1%) | 1 (<1%) |
| Diarrhea | 22 (4%) | 1 (<1%) | - | 16 (3%) | - | - |
| Nausea | 5 (1%) | - | - | 4 (1%) | - | - |
| Fatigue | 34 (6%) | - | - | 29 (6%) | - | - |
| Edema limbs | 11 (2%) | - | - | 12 (2%) | - | - |
| Infusion related reaction | - | - | - | 3 (1%) | 3 (1%) | - |
| Infections and infestations - Other | 5 (1%) | - | - | 2 (<1%) | - | - |
| Sepsis | - | 3 (1%) | - | - | 9 (2%) | - |
| Skin infection | 3 (1%) | - | - | 5 (1%) | - | - |
| Lung infection | 9 (2%) | - | - | 27 (5%) | - | - |
| Creatinine increased | 2 (<1%) | - | - | 6 (1%) | 1 (<1%) | - |
| Weight loss | 5 (1%) | - | - | 3 (1%) | - | - |
| Ejection fraction decreased | - | - | - | 8 (2%) | 1 (<1%) | - |
| Anorexia | 5 (1%) | - | - | 2 (<1%) | - | - |
| Dehydration | 9 (2%) | - | - | 4 (1%) | - | - |
| Hyperglycemia | 18 (3%) | 5 (1) | - | 29 (6%) | 5 (1%) | - |
| Hypokalemia | 5 (1%) | - | - | 7 (1%) | 1 (<1%) | - |
| Hyponatremia | 7 (1%) | 1 (<1) | - | 6 (1%) | 1 (<1%) | - |
| Back pain | 5 (1%) | - | - | 1 (<1%) | - | - |
| Pain in extremity | 5 (1%) | - | - | - | - | - |
| Generalized muscle weakness | 12 (2%) | - | - | 3 (1%) | - | - |
| Dizziness | 7 (1%) | - | - | - | - | - |
| Peripheral motor neuropathy | 5 (1%) | - | - | 1 (<1%) | - | - |
| Peripheral sensory neuropathy | 39 (7%) | - | - | 3 (1%) | - | - |
| Syncope | 8 (2%) | - | - | 5 (1%) | - | - |
| Insomnia | 12 (2%) | - | - | 11 (2%) | - | - |
| Acute kidney injury | 3 (1%) | - | - | 9 (2%) | 4 (1%) | 1 (<1%) |
| Dyspnea | 9 (2%) | - | - | 32 (6%) | 6 (1%) | - |
| Hypoxia | 2 (<1%) | - | - | 6 (1%) | 1 (<1%) | 1 (<1%) |
| Pneumonitis | 2 (<1%) | - | - | 5 (1%) | - | - |
| Respiratory failure | - | - | - | - | 5 (1%) | - |
| Rash acneiform | 10 (2%) | - | - | 12 (2%) | - | - |
| Rash maculo-papular | 7 (1%) | - | - | 18 (3%) | - | - |
| Hypertension | 11 (2%) | - | - | 21 (4%) | 1 (<1%) | - |
| Hypotension | 11 (2%) | - | - | 6 (1%) | - | - |
| Thromboembolic event | 7 (1%) | 4 (1%) | - | 23 (4%) | 3 (1%) | - |
| WORST DEGREE | 197 (37%) | 20 (4%) | 1 (<1%) | 211 (40%) | 36 (7%) | 7 (1%) |
^
Grade 3–5 non-hematologic adverse events at least possibly attributable to treatment occurring at least 1% in either arm