Summary of serious adverse events
| . | Refractory study . | Relapsed study . | Treatment-naive study . | |
|---|---|---|---|---|
| Rabbit ATG (n = 27) . | Alemtuzumab (n = 27) . | Alemtuzumab (n = 25) . | Alemtuzumab (n = 16) . | |
| Serum sickness, n | 2 | 0 | 0 | 0 |
| Hemorrhage, n | ||||
| Gastrointestinal | 2 | 0 | 2 | 0 |
| Gingival | 2 | 0 | 0 | 0 |
| Epistaxis | 1 | 0 | 0 | 0 |
| Infection, n | ||||
| Neutropenic fever, negative cultures | 6 | 8 | 11 | 10 |
| Neutropenic fever, positive cultures | 4 | 5 | 4 | 3 |
| Pneumonia | 0 | 2 | 1 | 3 |
| Urinary tract | 0 | 1 | 1 | 1 |
| Clostridium difficile | 0 | 1 | 0 | 2 |
| Candidemia | 0 | 0 | 1 | 0 |
| Septic shock | 0 | 1 | 0 | 0 |
| Perirectal abscess | 0 | 0 | 2 | 0 |
| Cervical abscess | 0 | 0 | 1 | 0 |
| Skin abscess | 0 | 0 | 1 | 0 |
| Cholecystitis | 0 | 1 | 0 | 0 |
| Tonsillitis/pharyngitis | 0 | 1 | 0 | 0 |
| PML | 0 | 0 | 1 | 0 |
| Cellulitis | 0 | 0 | 1 | 0 |
| Viral exanthema | 0 | 1 | 0 | 0 |
| Upper respiratory infection | 2 | 2 | 2 | 1 |
| Parotitis | 0 | 1 | 0 | 0 |
| Other | 3 | 1 | 7 | 3 |
| . | Refractory study . | Relapsed study . | Treatment-naive study . | |
|---|---|---|---|---|
| Rabbit ATG (n = 27) . | Alemtuzumab (n = 27) . | Alemtuzumab (n = 25) . | Alemtuzumab (n = 16) . | |
| Serum sickness, n | 2 | 0 | 0 | 0 |
| Hemorrhage, n | ||||
| Gastrointestinal | 2 | 0 | 2 | 0 |
| Gingival | 2 | 0 | 0 | 0 |
| Epistaxis | 1 | 0 | 0 | 0 |
| Infection, n | ||||
| Neutropenic fever, negative cultures | 6 | 8 | 11 | 10 |
| Neutropenic fever, positive cultures | 4 | 5 | 4 | 3 |
| Pneumonia | 0 | 2 | 1 | 3 |
| Urinary tract | 0 | 1 | 1 | 1 |
| Clostridium difficile | 0 | 1 | 0 | 2 |
| Candidemia | 0 | 0 | 1 | 0 |
| Septic shock | 0 | 1 | 0 | 0 |
| Perirectal abscess | 0 | 0 | 2 | 0 |
| Cervical abscess | 0 | 0 | 1 | 0 |
| Skin abscess | 0 | 0 | 1 | 0 |
| Cholecystitis | 0 | 1 | 0 | 0 |
| Tonsillitis/pharyngitis | 0 | 1 | 0 | 0 |
| PML | 0 | 0 | 1 | 0 |
| Cellulitis | 0 | 0 | 1 | 0 |
| Viral exanthema | 0 | 1 | 0 | 0 |
| Upper respiratory infection | 2 | 2 | 2 | 1 |
| Parotitis | 0 | 1 | 0 | 0 |
| Other | 3 | 1 | 7 | 3 |
Serious adverse events depicted are those that resulted in prolonged hospitalization, hospital admission, or death. Events shown are those that occurred after the initial cycle of immunosuppression for each study. Repeated hospitalizations in the same subject were counted as separate events.
PML indicates progressive multifocal leukoencephalopathy.