TABLE 3.
SAEs by treatment arm
| Patient number | Type of SAE | Study arm: Brief description of the event | Relationship to therapy |
|---|---|---|---|
| 01–0001 | Hospitalization—initial or prolonged | IST: After therapy-febrile neutropenia, prior to count recovery | Possible |
| 01–0001 | Hospitalization—initial or prolonged | IST: After therapy—fever on cyclosporine, after count recovery | Probable |
| 01–0009 | Hospitalization—initial or prolonged | IST: After therapy, febrile neutropenia, prior to count recovery | Possible |
| 02–0014 | Life-threatening; hospitalization—initial or prolonged | IST: After therapy—acute respiratory failure and pulmonary and sinus aspergillosis requiring intubation, chest tube placement, and debridement, prior to count recovery | Possible |
| 04–0001 | Hospitalization—initial or prolonged | IST: Prior to therapy—cellulitis | Unrelated |
| 04–0001 | Hospitalization—initial or prolonged | IST: After therapy—fever and bacteremia, prior to count recovery | Possible |
| 07–0002 | Hospitalization—initial or prolonged | IST: After therapy—serum sickness | Definite |
| 07–0003 | Life-threatening; hospitalization—initial or prolonged | IST: After therapy—sepsis, febrile neutropenia after therapy | Possible |
| 07–0003 | Life-threatening; hospitalization—initial or prolonged | IST: After therapy—sepsis, febrile neutropenia after therapy (1 week after hospitalization listed above) | Possible |
| 07–0003 | Hospitalization—initial or prolonged | IST: After therapy—syncope in the presence of major anemia, mild swelling of tongue | Unrelated |
| 08–0001 | Death | IST: CR to initial IST with relapse after weaning nonresponsive to salvage IST. Died day +95 after 9/10 salvage BMT due to disseminated toxoplasmosis | Unrelated (was no longer on study therapy) |
| 09–0003 | Hospitalization—initial or prolonged | IST: After therapy—dehydration, acute kidney injury, elevated CsA level, fever | Definite |
| 01–0002 | Hospitalization—initial or prolonged | BMT: Prior to therapy—febrile neutropenia, adenopathy | Unrelated |
| 01–0002 | Life-threatening; hospitalization—initial or prolonged | BMT: Prior to therapy—febrile neutropenia, hypotension/sepsis, rash—presumed DRESS syndrome, EBV viremia, pulmonary nodules, candidemia with Candida parapsilosis, and bacteremia with Stenotrophomonas maltophilia | Unrelated |
| 01–0002 | Hospitalization—initial or prolonged | BMT: Prior to therapy—febrile neutropenia, mouth ulcers, lung nodules | Unrelated |
| 01–0002 | Hospitalization—initial or prolonged | BMT: After therapy—recurrence of Stenotrophomonas bacteremia, acute kidney injury, persistent EBV viremia, biopsy of lymphadenopathy not consistent with lymphoproliferative disease | Possible |
| 07–0012 | Hospitalization—initial or prolonged | BMT: After therapy—febrile neutropenia, decreasing blood counts, possible graft rejection | Possible |
| 07–0012 | Life-threatening | BMT: After therapy—graft rejection: initial engraftment followed by chimerism confirmed rejection on day +34 | Definite |
CsA, cyclosporine; DRESS, drug rash with eosinophilia and systemic symptoms; EBV, Epstein-Barr virus. SAE, severe adverse event.