Table 6. Summary of Central Pathology Review Findings.
Pathology Finding | All Patients with Pathology Assessment (Evaluable for Day +100 Post-HSCT Survival) (n = 52)* | Patients with Pathology Assessment Who Were Evaluable for Response (n = 47)* |
---|---|---|
VOD, n (%) | 33 (63) | 31 (66) |
VOD plus another histologic diagnosis, n (%) | 5 (10) | 5 (11) |
Findings consistent with, but not diagnostic of, VOD, n (%) | 3 (6) | 3 (6) |
Alternative diagnosis, n (%)† | 10 (19) | 8 (17) |
GVHD, n (%) | 4 (8) | 4 (9) |
Insignificant for diagnosis, n (%) | 1 (2) | 0 (0) |
HSCT indicates hematopoietic stem cell transplantation; VOD, veno-occlusive disease; GVHD, graft-versus-host disease.
One patient had no VOD on liver biopsy and was excluded before initiation of defibrotide. One patient had no VOD on liver biopsy performed after initiation of defibrotide; this patient was removed from the trial.
In addition to the 4 patients with possible, probable, or definite GVHD, alternative diagnoses were cirrhosis in 2 patients and viral hepatitis, shock, abscesses, and GVHD or cholangitis lenta each in 1 patient.