Summary of serious infections in patients treated with deferiprone in sponsored clinical trials
| Total patients (N = 977) . | |||||||
|---|---|---|---|---|---|---|---|
| ANC range, × 109/L . | Primary diagnosis . | Serious/severe infections, n . | Preferred term . | Nadir ANC, × 109/L . | Characteristics of infection . | ||
| Severity seriousness . | Causality to DFP . | Outcome . | |||||
| Group 1 (0.2-0.5) | — | 0 | — | — | — | — | — |
| Group 2 (0.1-0.199) | — | 0 | — | — | — | — | — |
| Group 3 (<0.1) | 3 | ||||||
| Hereditary spherocytosis | Parvovirus | 0 | Severe serious | Not related | Hospitalized, recovered | ||
| Hereditary hemochromatosis | Pseudomonal sepsis | 0.01 | NA serious | Related | Hospitalized, fatal | ||
| Hereditary hemochromatosis | RTI and esophageal candidiasis | 0.01 | Severe not serious | Related | Hospitalized, recovered with sequelae | ||
| Total patients (N = 977) . | |||||||
|---|---|---|---|---|---|---|---|
| ANC range, × 109/L . | Primary diagnosis . | Serious/severe infections, n . | Preferred term . | Nadir ANC, × 109/L . | Characteristics of infection . | ||
| Severity seriousness . | Causality to DFP . | Outcome . | |||||
| Group 1 (0.2-0.5) | — | 0 | — | — | — | — | — |
| Group 2 (0.1-0.199) | — | 0 | — | — | — | — | — |
| Group 3 (<0.1) | 3 | ||||||
| Hereditary spherocytosis | Parvovirus | 0 | Severe serious | Not related | Hospitalized, recovered | ||
| Hereditary hemochromatosis | Pseudomonal sepsis | 0.01 | NA serious | Related | Hospitalized, fatal | ||
| Hereditary hemochromatosis | RTI and esophageal candidiasis | 0.01 | Severe not serious | Related | Hospitalized, recovered with sequelae | ||
DFP, deferiprone; NA, not applicable; RTI, respiratory tract infection.