Serious adverse events and overall mortality
. | Group A, val/gan; n = 26 . | Group B, gan/val; n = 22 . |
|---|---|---|
| Serious adverse events* | ||
| Total no. of patients with a serious adverse event (%) | 15 (57.7) | 16 (72.7) |
| Myelotoxicity (%) | 3 (11.5) | 3 (13.6) |
| Anemia | 2 | 0 |
| Febrile neutropenia | 0 | 1 |
| Severe neutropenia†/pancytopenia | 1 | 1 |
| Thrombocytopenic purpura | 0 | 1 |
| Gastrointestinal disorders (%) | 2 (7.7) | 1 (4.5) |
| Diarrhea | 0 | 1 |
| Gastrointestinal hemorrhage | 2 | 0 |
| Secondary infections (%) | 8 (30.8) | 8 (36.4) |
| Fungal infection | 1 | 0 |
| Recurrent CMV infections | 3 | 4 |
| CMV interstitial pneumonia (CMV-IP) | 0 | 2§ |
| Total no. of patients w/serious adverse event leading to withdrawal (%) | 0 (0.0) | 1 (4.5) |
| Severe neutropenia | 0 (0.0) | 1 (4.5) |
| Mortality | ||
| Overall mortality (%)‡ | 2 (7.7) | 4 (18.2) |
| 100-day mortality | 1∥ | 3¶ |
| Fungal pneumonia | 1; day 32 | 0 |
| Non-CMV respiratory failure | 0 | 1; day 23 |
| Progressive disease | 0 | 2; days 62 and 76 |
. | Group A, val/gan; n = 26 . | Group B, gan/val; n = 22 . |
|---|---|---|
| Serious adverse events* | ||
| Total no. of patients with a serious adverse event (%) | 15 (57.7) | 16 (72.7) |
| Myelotoxicity (%) | 3 (11.5) | 3 (13.6) |
| Anemia | 2 | 0 |
| Febrile neutropenia | 0 | 1 |
| Severe neutropenia†/pancytopenia | 1 | 1 |
| Thrombocytopenic purpura | 0 | 1 |
| Gastrointestinal disorders (%) | 2 (7.7) | 1 (4.5) |
| Diarrhea | 0 | 1 |
| Gastrointestinal hemorrhage | 2 | 0 |
| Secondary infections (%) | 8 (30.8) | 8 (36.4) |
| Fungal infection | 1 | 0 |
| Recurrent CMV infections | 3 | 4 |
| CMV interstitial pneumonia (CMV-IP) | 0 | 2§ |
| Total no. of patients w/serious adverse event leading to withdrawal (%) | 0 (0.0) | 1 (4.5) |
| Severe neutropenia | 0 (0.0) | 1 (4.5) |
| Mortality | ||
| Overall mortality (%)‡ | 2 (7.7) | 4 (18.2) |
| 100-day mortality | 1∥ | 3¶ |
| Fungal pneumonia | 1; day 32 | 0 |
| Non-CMV respiratory failure | 0 | 1; day 23 |
| Progressive disease | 0 | 2; days 62 and 76 |
val indicate valganciclovir; gan, ganciclovir.
Details are provided for selected serious adverse events
ANC < 500 cells/μL for 2 or more consecutive days
No deaths occurred in patients with intestinal GVHD
Both patients who developed CMV-IP had completed study drug administration since 11 days (n = 1) and 40 days (n = 1), respectively, and recovered completely
One additional patient died after safety follow-up from relapse of acute myeloid leukemia
One additional patient died from RSV pneumonia at day 110 after randomization