Most common grade 3 or higher side effects of the IMiDs thalidomide, lenalidomide, pomalidomide reported in pivotal trials
| . | Thalidomide . | Lenalidomide . | Pomalidomide . | |||||
|---|---|---|---|---|---|---|---|---|
| Type of side effect . | MPT10 . | Thal-Dex9 . | RD11-13 . | Rd1849 . | Rdcont49 . | MPR63 . | MPR-R63 . | Pom-dex14 . |
| Hematological, % | ||||||||
| Anemia | 14 | NR | 8-13 | 16 | 18 | 29 | 27 | 33 |
| Neutropenia | 48 | 9 | 12-41 | 26 | 28 | 96 | 100 | 48 |
| Neutropenic fever | NR | NR | 3 | NR | NR | 2 | 7 | 10 |
| Thrombocytopenia | 14 | NR | 6-15 | 8 | 8 | 50 | 46 | 22 |
| Nonhematological, % | ||||||||
| Peripheral neuropathy | 10 | 13† | 2 | 1 | <1 | NR | NR | 1 |
| Diarrhea | NR | NR | 3 | 3 | 4 | 3 | 1 | 1 |
| Constipation | 10 | 8 | 2-3 | 2 | 2 | NR | NR | 2 |
| Nausea | 1 | 4 | 1-3 | NR | NR | NR | NR | 1 |
| Infection | 13 | 2 | 10-19 | 21 | 22 | 10 | 15 | 30 |
| Fatigue | 8* | 15 | 6-15 | 9 | 7 | 5 | 2 | 5 |
| Dyspnea | NR | 11 | 2-3 | 4 | 6 | NR | NR | 5 |
| Cardiac disorders | 2 | NR | 6 | 7 | 12 | 5 | 5 | NR |
| Thrombosis or embolism | 12 | 20 | 8-26 | 6 | 8 | 1 | 5 | 1 |
| Rash | NR | 4 | 1 | 5 | 6 | 5 | 5 | NR |
| . | Thalidomide . | Lenalidomide . | Pomalidomide . | |||||
|---|---|---|---|---|---|---|---|---|
| Type of side effect . | MPT10 . | Thal-Dex9 . | RD11-13 . | Rd1849 . | Rdcont49 . | MPR63 . | MPR-R63 . | Pom-dex14 . |
| Hematological, % | ||||||||
| Anemia | 14 | NR | 8-13 | 16 | 18 | 29 | 27 | 33 |
| Neutropenia | 48 | 9 | 12-41 | 26 | 28 | 96 | 100 | 48 |
| Neutropenic fever | NR | NR | 3 | NR | NR | 2 | 7 | 10 |
| Thrombocytopenia | 14 | NR | 6-15 | 8 | 8 | 50 | 46 | 22 |
| Nonhematological, % | ||||||||
| Peripheral neuropathy | 10 | 13† | 2 | 1 | <1 | NR | NR | 1 |
| Diarrhea | NR | NR | 3 | 3 | 4 | 3 | 1 | 1 |
| Constipation | 10 | 8 | 2-3 | 2 | 2 | NR | NR | 2 |
| Nausea | 1 | 4 | 1-3 | NR | NR | NR | NR | 1 |
| Infection | 13 | 2 | 10-19 | 21 | 22 | 10 | 15 | 30 |
| Fatigue | 8* | 15 | 6-15 | 9 | 7 | 5 | 2 | 5 |
| Dyspnea | NR | 11 | 2-3 | 4 | 6 | NR | NR | 5 |
| Cardiac disorders | 2 | NR | 6 | 7 | 12 | 5 | 5 | NR |
| Thrombosis or embolism | 12 | 20 | 8-26 | 6 | 8 | 1 | 5 | 1 |
| Rash | NR | 4 | 1 | 5 | 6 | 5 | 5 | NR |
MPR, melphalan plus prednisone plus lenalidomide for 9 cycles; MPR-R, MPR followed by lenalidomide maintenance; MPT, melphalan plus prednisone plus thalidomide; NR, not reported; Pom-dex, pomalidomide plus weekly dexamethasone; RD, lenalidomide plus high-dose dexamethasone; Rd18, lenalidomide plus weekly dexamethasone for 18 cycles; Rdcont, lenalidomide plus weekly dexamethasone until progression; Thal-Dex, thalidomide plus high-dose dexamethasone.
Listed as a combined event of somnolence/fatigue/dizziness in the original publication, but in the fatigue category in this table.
Six percent sensory and 7% motor PN.