AEs occurring in ≥10% of patients and all AEs of grade 3 or 4 in treated set by dose group
| AE . | N (%) . | ||||
|---|---|---|---|---|---|
| Lenalidomide dose, mg . | Treated set (N = 19) . | ||||
| 10 (n = 7) . | 15 (n = 3) . | 20 (n = 6) . | 25 (n = 3) . | ||
| Total with ≥1 AE (all grades) | 7 (100) | 3 (100) | 6 (100) | 3 (100) | 19 (100) |
| Constipation | 3 (42.9) | 1 (33.3) | 5 (83.3) | 1 (33.3) | 10 (52.6) |
| Neutropenia/decreased neutrophil count | 1 (14.3) | 1 (33.3) | 4 (66.7) | 3 (100) | 9 (47.4) |
| Asthenia | 1 (14.3) | 2 (66.7) | 2 (33.3) | 2 (66.7) | 7 (36.8) |
| Cough | 1 (14.3) | 2 (66.7) | 1 (16.7) | 1 (33.3) | 5 (26.3) |
| Muscle spasms | 1 (14.3) | 0 (0.0) | 3 (50.0) | 1 (33.3) | 5 (26.3) |
| Diarrhea | 1 (14.3) | 1 (33.3) | 1 (16.7) | 1 (33.3) | 4 (21.1) |
| Pyrexia | 2 (28.6) | 1 (33.3) | 1(16.7) | 0 (0.0) | 4 (21.1) |
| Infusion-related reaction | 0 (0.0) | 1 (33.3) | 1 (16.7) | 1 (33.3) | 3 (15.8) |
| Nausea | 1 (14.3) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 3 (15.8) |
| Rash | 1 (14.3) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 3 (15.8) |
| Rhinitis, allergic | 0 (0.0) | 1 (33.3) | 1 (16.7) | 1 (33.3) | 3 (15.8) |
| Weight increase | 1 (14.3) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 3 (15.8) |
| Weight loss | 2 (28.6) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 3 (15.8) |
| Bronchitis | 1 (14.3) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 2 (10.5) |
| Dry skin | 0 (0.0) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 2 (10.5) |
| Fatigue | 1 (14.3) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 2 (10.5) |
| Headache | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (10.5) |
| Rhinitis | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (33.3) | 2 (10.5) |
| Sinusitis | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 2 (10.5) |
| Upper abdominal pain | 2 (28.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (10.5) |
| Urinary tract infection | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (10.5) |
| Total with ≥1 grade 3/4 AE | 4 (57.1) | 2 (66.7) | 5 (83.3) | 3 (100) | 14 (73.7) |
| Neutropenia/decreased neutrophil count | 1 (14.3) | 1 (33.3) | 4 (66.7) | 3 (100) | 9 (47.4) |
| Anemia | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (5.3) |
| Acute myeloid leukemia | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Breast cancer | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Hypertension | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Hypokalemia | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (5.3) |
| Ischemic stroke | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (5.3) |
| Lung infection | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (5.3) |
| Pleural effusion | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Pulmonary embolism | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 1 (5.3) |
| AE . | N (%) . | ||||
|---|---|---|---|---|---|
| Lenalidomide dose, mg . | Treated set (N = 19) . | ||||
| 10 (n = 7) . | 15 (n = 3) . | 20 (n = 6) . | 25 (n = 3) . | ||
| Total with ≥1 AE (all grades) | 7 (100) | 3 (100) | 6 (100) | 3 (100) | 19 (100) |
| Constipation | 3 (42.9) | 1 (33.3) | 5 (83.3) | 1 (33.3) | 10 (52.6) |
| Neutropenia/decreased neutrophil count | 1 (14.3) | 1 (33.3) | 4 (66.7) | 3 (100) | 9 (47.4) |
| Asthenia | 1 (14.3) | 2 (66.7) | 2 (33.3) | 2 (66.7) | 7 (36.8) |
| Cough | 1 (14.3) | 2 (66.7) | 1 (16.7) | 1 (33.3) | 5 (26.3) |
| Muscle spasms | 1 (14.3) | 0 (0.0) | 3 (50.0) | 1 (33.3) | 5 (26.3) |
| Diarrhea | 1 (14.3) | 1 (33.3) | 1 (16.7) | 1 (33.3) | 4 (21.1) |
| Pyrexia | 2 (28.6) | 1 (33.3) | 1(16.7) | 0 (0.0) | 4 (21.1) |
| Infusion-related reaction | 0 (0.0) | 1 (33.3) | 1 (16.7) | 1 (33.3) | 3 (15.8) |
| Nausea | 1 (14.3) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 3 (15.8) |
| Rash | 1 (14.3) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 3 (15.8) |
| Rhinitis, allergic | 0 (0.0) | 1 (33.3) | 1 (16.7) | 1 (33.3) | 3 (15.8) |
| Weight increase | 1 (14.3) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 3 (15.8) |
| Weight loss | 2 (28.6) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 3 (15.8) |
| Bronchitis | 1 (14.3) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 2 (10.5) |
| Dry skin | 0 (0.0) | 1 (33.3) | 1 (16.7) | 0 (0.0) | 2 (10.5) |
| Fatigue | 1 (14.3) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 2 (10.5) |
| Headache | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (10.5) |
| Rhinitis | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (33.3) | 2 (10.5) |
| Sinusitis | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 2 (10.5) |
| Upper abdominal pain | 2 (28.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (10.5) |
| Urinary tract infection | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (10.5) |
| Total with ≥1 grade 3/4 AE | 4 (57.1) | 2 (66.7) | 5 (83.3) | 3 (100) | 14 (73.7) |
| Neutropenia/decreased neutrophil count | 1 (14.3) | 1 (33.3) | 4 (66.7) | 3 (100) | 9 (47.4) |
| Anemia | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (5.3) |
| Acute myeloid leukemia | 0 (0.0) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Breast cancer | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Hypertension | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Hypokalemia | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (5.3) |
| Ischemic stroke | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (5.3) |
| Lung infection | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 1 (5.3) |
| Pleural effusion | 1 (14.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (5.3) |
| Pulmonary embolism | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (33.3) | 1 (5.3) |