Number of patients with adverse events (AE) and serious AE (SAE) from baseline to 24 months.
| Variables | SLS I–CYC, n = 79 | SLS II–CYC, n = 69 |
|---|---|---|
| AE* | ||
| Leukopenia | 19 | 30 |
| Neutropenia | 7 | 5 |
| Anemia | 4 | 13 |
| Hematuria | 10 | 2 |
| Pneumonia | 6 | 4 |
| SAE | ||
| No. patients with SAE | 47 | 22 |
| Related to treatment† | 13 | 8 |
| Not related to treatment† | 34 | 16 |
| Death | 6 | 11 |
↵* Predefined by protocol as likely to be related to study drug and to warrant protocol-defined management (except for pneumonia): anemia = Hgb < 10 g/dl or < 9 for those with Hgb < 11 at enrollment; leukopenia = WBC < 2500; neutropenia = neutrophils < 1000; thrombocytopenia = platelets < 100,000; hematuria > 25 red blood cells (or 10–15 red blood cells on > 1 urinalysis) in absence of urinary tract infection or menses.
↵† According to consensus classification by Morbidity and Mortality Committee. SLS: Scleroderma Lung Study; CYC: cyclophosphamide; Hgb: hemoglobin; WBC: white blood cells.