Baseline demographic and disease characteristics in the ITT and safety population (101 patients)
| Parameter . | Dexamethasone . | Dexamethasone plus rituximab . | P . |
|---|---|---|---|
| Number of patients | 52 | 49 | |
| Male/female | 19/33 (37%/63%) | 22/27 (45%/55%) | .39 |
| Ethnic origin | 98% white | 100% white | .98 |
| 2% Asian | |||
| Age, y (mean ± SD) | 47 ± 19 | 49 ± 16 | .60 |
| Months from diagnosis, median, n (range)* | 0 (0-103) | 0 (0-100) | .14 |
| Patients with newly diagnosed ITP, n (%) | 44 (85) | 41 (84) | |
| Patients with persistent or chronic ITP, n (%) | 8 (15) | 8 (16) | |
| Platelets 0-10 × 109/L, n (%) | 24 (46) | 22 (45) | .80 |
| Platelets 10-20 × 109/L, n (%) | 27 (52) | 25 (51) | |
| Platelets > 20 × 109/L, n (%)† | 1 (2)‡ | 2 (4)§ |
| Parameter . | Dexamethasone . | Dexamethasone plus rituximab . | P . |
|---|---|---|---|
| Number of patients | 52 | 49 | |
| Male/female | 19/33 (37%/63%) | 22/27 (45%/55%) | .39 |
| Ethnic origin | 98% white | 100% white | .98 |
| 2% Asian | |||
| Age, y (mean ± SD) | 47 ± 19 | 49 ± 16 | .60 |
| Months from diagnosis, median, n (range)* | 0 (0-103) | 0 (0-100) | .14 |
| Patients with newly diagnosed ITP, n (%) | 44 (85) | 41 (84) | |
| Patients with persistent or chronic ITP, n (%) | 8 (15) | 8 (16) | |
| Platelets 0-10 × 109/L, n (%) | 24 (46) | 22 (45) | .80 |
| Platelets 10-20 × 109/L, n (%) | 27 (52) | 25 (51) | |
| Platelets > 20 × 109/L, n (%)† | 1 (2)‡ | 2 (4)§ |
ITT indicates intention to treat; and ITP, primary immune thrombocytopenia.
Some patients had a previous diagnosis of ITP initially not requiring treatment.
Three patients, 1 in the dexamethasone arm and 2 in the dexamethasone plus rituximab arm, were randomized despite a platelet count greater than 20 × 109/L.
Platelet count 21 × 109/L.
Platelet count 21 × 109/L and 22 × 109/L.