Causes of deaths according to time of event (≤ 3 years after transplantation vs > 3 years after HCT)
| Cause of death . | ≤ 3 y after HCT . | > 3 y after HCT . | ||
|---|---|---|---|---|
| G-PBMC (N = 81) . | BM (N = 91) . | G-PBMC (N = 51) . | BM (N = 48) . | |
| Nonrelapse | ||||
| Noninfectious pneumonia | 7 | 13 | 0 | 0 |
| Sinusoidal obstruction syndrome | 1 | 1 | 0 | 0 |
| Multiorgan failure | 2 | 2 | 0 | 0 |
| Hemorrhage | 1 | 1 | 0 | 0 |
| Cardiac failure | 1 | 1 | 0 | 0 |
| GVHD with or without infection | 3 | 3 | 5 | 1 |
| Infection (without concurrent GVHD) | 4 | 6 | 0 | 2 |
| Secondary cancer | 0 | 0 | 0 | 1 |
| Other | 0 | 0 | 0 | 1 |
| Relapse | 11 | 16 | 3 | 1 |
| Total | 30 | 43 | 8 | 6 |
| Cause of death . | ≤ 3 y after HCT . | > 3 y after HCT . | ||
|---|---|---|---|---|
| G-PBMC (N = 81) . | BM (N = 91) . | G-PBMC (N = 51) . | BM (N = 48) . | |
| Nonrelapse | ||||
| Noninfectious pneumonia | 7 | 13 | 0 | 0 |
| Sinusoidal obstruction syndrome | 1 | 1 | 0 | 0 |
| Multiorgan failure | 2 | 2 | 0 | 0 |
| Hemorrhage | 1 | 1 | 0 | 0 |
| Cardiac failure | 1 | 1 | 0 | 0 |
| GVHD with or without infection | 3 | 3 | 5 | 1 |
| Infection (without concurrent GVHD) | 4 | 6 | 0 | 2 |
| Secondary cancer | 0 | 0 | 0 | 1 |
| Other | 0 | 0 | 0 | 1 |
| Relapse | 11 | 16 | 3 | 1 |
| Total | 30 | 43 | 8 | 6 |
Overall, 5 of 172 patients were not treated per intent. The results for these patients were included in the intention-to-treat analysis according to their randomly assigned treatment. Two patients randomized to BM received G-PBMC, and 3 patients randomized to G-PBMC received BM; the latter 3 patients experienced late NRM (infection without GVHD, n = 2; pancreatitis, n = 1). Because of the small number of late (> 3 years after HCT) deaths, Table 1 shows causes of deaths according to types of stem cell product given (not based on intention to treat). Causes of late deaths were determined by retrospective review of medical records. In the G-PBMC group, causes of late NRM were bacterial pneumonia (n = 3), sepsis (n = 1), and bronchiolitis obliterans without apparent infection (n = 1). In the BM group, causes of late NRM were sepsis (n = 2), ovarian cancer (n = 1), pancreatitis (n = 1), and systemic sclerosis without apparent infection (n = 1).