Occurrence of grade 3 or 4 adverse events in thalidomide-naive and thalidomide-exposed patients
| Adverse event . | No prior exposure to thalidomide, % . | Prior exposure to thalidomide, % . | ||
|---|---|---|---|---|
| Len/Dex, n = 226 . | Placebo/Dex, n = 204 . | Len/Dex, n = 127 . | Placebo/Dex, n = 147 . | |
| DVT/PE | 9.7* | 4.4* | 15.0* | 2.7* |
| Neutropenia | 32.3* | 4.4* | 40.9* | 2.1* |
| Thrombocytopenia | 10.6 | 5.4 | 17.3* | 7.5* |
| Anemia | 10.2 | 5.4 | 11.8 | 6.9 |
| Febrile neutropenia | 2.7* | 0.0* | 1.6 | 0 |
| Infection | 15.5* | 7.4* | 14.2 | 8.9 |
| Fatigue | 8.0 | 3.9 | 3.9 | 6.2 |
| Gastrointestinal | 5.3 | 2.0 | 2.4 | 1.4 |
| Peripheral neuropathy | 0.4 | 0.5 | 3.1 | 0.7 |
| Adverse event . | No prior exposure to thalidomide, % . | Prior exposure to thalidomide, % . | ||
|---|---|---|---|---|
| Len/Dex, n = 226 . | Placebo/Dex, n = 204 . | Len/Dex, n = 127 . | Placebo/Dex, n = 147 . | |
| DVT/PE | 9.7* | 4.4* | 15.0* | 2.7* |
| Neutropenia | 32.3* | 4.4* | 40.9* | 2.1* |
| Thrombocytopenia | 10.6 | 5.4 | 17.3* | 7.5* |
| Anemia | 10.2 | 5.4 | 11.8 | 6.9 |
| Febrile neutropenia | 2.7* | 0.0* | 1.6 | 0 |
| Infection | 15.5* | 7.4* | 14.2 | 8.9 |
| Fatigue | 8.0 | 3.9 | 3.9 | 6.2 |
| Gastrointestinal | 5.3 | 2.0 | 2.4 | 1.4 |
| Peripheral neuropathy | 0.4 | 0.5 | 3.1 | 0.7 |
All comparisons without adjustment for multiplicity. P value more than .05 for all adverse events for the comparison between no prior exposure versus prior exposure to thalidomide in patients receiving lenalidomide plus dexamethasone.
Dex indicates dexamethasone; DVT, deep-vein thrombosis; Len, lenalidomide; NS, not significant; PE, pulmonary embolism.
P value less than .05 based on comparison between Len/Dex versus Dex using Fisher exact test.