Table 3. Adverse reactions.
| Adverse reaction | KRdc (n = 511) | Rdc (n = 257) | Tdc (n = 261) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
| Haematological | ||||||||||||
| Anaemia | 354 (69.3%) | 51 (10.0%) | 1 (0.2%) | 0 | 185 (70.9%) | 14 (5.4%) | 1 (0.4%) | 0 | 174 (67.7%) | 12 (4.7%) | 0 | 0 |
| Neutrophil count decrease | 172 (33.7%) | 59 (11.5%) | 25 (4.9%) | 0 | 76 (29.1%) | 40 (15.3%) | 18 (6.9%) | 0 | 72 (28.0%) | 18 (7.0%) | 14 (5.4%) | 1 (0.4%) |
| Platelet count decrease | 213 (41.7%) | 27 (5.3%) | 16 (3.1%) | 0 | 80 (30.7%) | 6 (2.3%) | 0 | 0 | 35 (13.6%) | 3 (1.2%) | 0 | 0 |
| Infections | ||||||||||||
| Cellulitis | 4 (0.8%) | 5 (1.0%) | 0 | 1 (0.2%)* | 1 (0.4%) | 1 (0.4%) | 0 | 0 | 0 | 1 (0.4%) | 0 | 0 |
| Lung infection | 31 (6.1%) | 50 (9.8%) | 3 (0.6%) | 1 (0.2%) | 25 (9.6%) | 18 (6.9%) | 1 (0.4%) | 0 | 18 (7.0%) | 20 (7.8%) | 2 (0.8%) | 1 (0.4%) |
| Sepsis | 1 (0.2%) | 10 (2.0%) | 14 (2.7%) | 1 (0.2%) | 0 | 7 (2.7%) | 3 (1.1%) | 2 (0.8%) | 0 | 5 (1.9%) | 2 (0.8%) | 0 |
| Gastrointestinal | ||||||||||||
| Constipation | 208 (40.7%) | 1 (0.2%) | 0 | 0 | 114 (43.7%) | 2 (0.8%) | 0 | 0 | 158 (61.5%) | 1 (0.4%) | 1 (0.4%) | 0 |
| Diarrhoea | 136 (26.6%) | 15 (2.9%) | 0 | 0 | 64 (24.5%) | 4 (1.5%) | 0 | 0 | 50 (19.5%) | 5 (1.9%) | 0 | 0 |
| Nausea | 94 (18.4%) | 4 (0.8%) | 0 | 0 | 45 (17.2%) | 5 (1.9%) | 0 | 0 | 65 (25.3%) | 1 (0.4%) | 0 | 0 |
| Gastrointestinal—other | 3 (0.6%) | 2 (0.4%) | 0 | 0 | 1 (0.4%) | 0 | 0 | 1 (0.4%)* | 4 (1.6%) | 2 (0.8%) | 0 | 0 |
| Neurological | ||||||||||||
| Peripheral motor neuropathy | 40 (7.8%) | 2 (0.4%) | 1 (0.2%) | 0 | 21 (8.0%) | 1 (0.4%) | 0 | 0 | 26 (10.1%) | 1 (0.4%) | 0 | 0 |
| Peripheral sensory neuropathy | 104 (20.4%) | 0 | 1 (0.2%) | 0 | 58 (22.2%) | 1 (0.4%) | 0 | 0 | 124 (48.2%) | 3 (1.2%) | 0 | 0 |
| Tremor | 29 (5.7%) | 0 | 0 | 0 | 30 (11.5%) | 1 (0.4%) | 0 | 0 | 58 (22.6%) | 0 | 0 | 0 |
| Other | ||||||||||||
| Back pain | 47 (9.2%) | 4 (0.8%) | 0 | 0 | 41 (15.7%) | 2 (0.8%) | 0 | 0 | 32 (12.5%) | 7 (2.7%) | 0 | 0 |
| Cough | 53 (10.4%) | 7 (1.4%) | 0 | 0 | 17 (6.5%) | 2 (0.8%) | 0 | 0 | 23 (8.9%) | 2 (0.8%) | 0 | 0 |
| Dyspnoea | 71 (13.9%) | 5 (1.0%) | 0 | 1 (0.2%) | 18 (6.9%) | 7 (2.7%) | 0 | 0 | 40 (15.6%) | 4 (1.6%) | 0 | 0 |
| Fatigue/lethargy | 204 (39.9%) | 5 (1.0%) | 0 | 0 | 153 (58.6%) | 96 (36.8%) | 5 (1.9%) | 0 | 124 (48.2%) | 3 (1.2%) | 0 | 0 |
| Fever | 85 (16.6%) | 26 (5.1%) | 0 | 0 | 31 (11.9%) | 4 (1.5%) | 1 (0.4%) | 0 | 23 (8.9%) | 9 (3.5%) | 1 (0.4%) | 0 |
| Oedema limbs | 60 (11.7%) | 2 (0.4%) | 0 | 0 | 32 (12.3%) | 0 | 0 | 0 | 48 (18.7%) | 0 | 0 | 0 |
| Pain—other | 40 (7.8%) | 3 (0.6%) | 0 | 0 | 26 (10.0%) | 3 (1.1%) | 0 | 0 | 16 (6.2%) | 6 (2.3%) | 0 | 0 |
| Pulmonary embolism | 1 (0.2%) | 11 (2.2%) | 3 (0.6%) | 0 | 2 (0.8%) | 8 (3.1%) | 2 (0.8%) | 0 | 0 | 12 (4.7%) | 2 (0.8%) | 0 |
| Rash | 116 (22.7%) | 29 (5.7%) | 3 (0.6%) | 0 | 45 (17.2%) | 6 (2.3%) | 0 | 0 | 32 (12.5%) | 5 (1.9%) | 0 | 0 |
| ARs of special interest | ||||||||||||
| Infusion reaction | 13 (2.5%) | 3 (0.6%) | 1 (0.2%) | 0 | 4 (1.5%) | 0 | 0 | 0 | 2 (0.8%) | 0 | 0 | 0 |
| Hypotension | 21 (4.1%) | 2 (0.4%) | 3 (0.6%) | 0 | 12 (4.6%) | 2 (0.8%) | 0 | 0 | 13 (5.1%) | 2 (0.8%) | 0 | 0 |
| Other thrombosis/embolism | 8 (1.6%) | 0 | 4 (0.8%) | 0 | 1 (0.4%) | 1 (0.4%) | 0 | 0 | 1 (0.4%) | 2 (0.8%) | 0 | 0 |
| Deep vein thrombosis | 30 (5.9%) | 6 (1.2%) | 0 | 0 | 10 (3.8%) | 2 (0.8%) | 1 (0.4%) | 0 | 17 (6.6%) | 4 (1.6%) | 0 | 0 |
| Heart failure | 1 (0.2%) | 4 (0.8%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypertension | 1 (0.2%) | 2 (0.4%) | 0 | 0 | 2 (0.8%) | 0 | 0 | 0 | 0 | 1 (0.4%) | 0 | 0 |
| Pulmonary oedema | 2 (0.4%) | 2 (0.4%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myocardial infarction | 0 | 1 (0.2%) | 1 (0.2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Acute coronary syndrome | 1 (0.2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cardiac disorders—other | 0 | 3 (0.6%) | 1 (0.2%) | 0 | 2 (0.8%) | 1 (0.4%) | 0 | 0 | 2 (0.8%) | 1 (0.4%) | 0 | 0 |
The safety population included all patients who received at least 1 dose of the trial treatment. Adverse reactions of any grade that were reported in >10% of patients in any treatment group, grade 3–5 in >5% of patients in any treatment group, or grade 5 in any treatment group are listed, along with other adverse events of special interest.
*Patients whose cause of death included “sepsis” in addition to the cause in this row.
AR, adverse reaction; KRdc, carfilzomib, lenalidomide, dexamethasone, and cyclophosphamide; Rdc, lenalidomide, dexamethasone, and cyclophosphamide; Tdc, thalidomide, dexamethasone, and cyclophosphamide.