Demography and disease characteristics: safety and principal efficacy populations
| . | Safety population . | Principal efficacy population . | ||
|---|---|---|---|---|
| Acyclovir n = 372 . | Valacyclovir n = 376 . | Acyclovir n = 300 . | Valacyclovir n = 305 . | |
| Median age, y (range) | 37.0 (13.0-59.0) | 37.0 (13.0-60.0) | 37.0 (13.0-59.0) | 36.0 (13.0-58.0) |
| Male/female (%) | 66/34 | 60/40 | 65/35 | 61/39 |
| Median weight, kg (range) | 71.0 (34.5-141.2) | 70.0 (41.0-134.1) | 71.5 (43.0-141.2) | 70.4 (42.0-134.1) |
| Median height, cm (range) | 171.0 (117.0-194.0) | 170.0 (148.0-190.0) | 172.0 (117.0-192.0) | 170.0 (149.0-190.0) |
| CMV serostatus (%) | ||||
| D+R+ | 54 | 57 | 54 | 59 |
| D−R+ | 28 | 24 | 32 | 25 |
| D+R− | 16 | 17 | 14 | 16 |
| Donor (%) | ||||
| Related/unrelated | 82/17 | 81/18 | 68/32 | 75/25 |
| HLA match (%) | ||||
| Identical/mismatch | 91/8 | 92/6 | 92/6 | 92/7 |
| Marrow T cell (%) | ||||
| Depleted/nondepleted | 15/84 | 13/86 | 13/86 | 12/86 |
| Conditioning regimen (%) | ||||
| Chemotherapy | 32 | 35 | 32 | 35 |
| Single TBI + chemo | 17 | 15 | 17 | 14 |
| Fract TBI + chemo | 46 | 49 | 48 | 49 |
| Other | 3 | 0 | 2 | 0 |
| Unknown | 2 | 1 | 1 | 1 |
| Underlying disease (%) | ||||
| Acute myeloblastic leukemia | 32 | 27 | 30 | 26 |
| Acute lymphoblastic leukemia | 17 | 16 | 18 | 16 |
| Chronic myelogenous leukemia/chronic granulocytic leukemia | 30 | 30 | 32 | 31 |
| Aplastic anemia | 4 | 4 | 3 | 4 |
| Non-Hodgkin lymphoma | 3 | 4 | 4 | 4 |
| Hodgkin lymphoma | 2 | 2 | 1 | 1 |
| Other | 12 | 16 | 12 | 16 |
| Unknown | 1 | 1 | 1 | 1 |
| Risk category (%)* | ||||
| Low | 63 | 62 | 65 | 65 |
| Intermediate | 25 | 24 | 26 | 22 |
| High | 10 | 12 | 6 | 11 |
| . | Safety population . | Principal efficacy population . | ||
|---|---|---|---|---|
| Acyclovir n = 372 . | Valacyclovir n = 376 . | Acyclovir n = 300 . | Valacyclovir n = 305 . | |
| Median age, y (range) | 37.0 (13.0-59.0) | 37.0 (13.0-60.0) | 37.0 (13.0-59.0) | 36.0 (13.0-58.0) |
| Male/female (%) | 66/34 | 60/40 | 65/35 | 61/39 |
| Median weight, kg (range) | 71.0 (34.5-141.2) | 70.0 (41.0-134.1) | 71.5 (43.0-141.2) | 70.4 (42.0-134.1) |
| Median height, cm (range) | 171.0 (117.0-194.0) | 170.0 (148.0-190.0) | 172.0 (117.0-192.0) | 170.0 (149.0-190.0) |
| CMV serostatus (%) | ||||
| D+R+ | 54 | 57 | 54 | 59 |
| D−R+ | 28 | 24 | 32 | 25 |
| D+R− | 16 | 17 | 14 | 16 |
| Donor (%) | ||||
| Related/unrelated | 82/17 | 81/18 | 68/32 | 75/25 |
| HLA match (%) | ||||
| Identical/mismatch | 91/8 | 92/6 | 92/6 | 92/7 |
| Marrow T cell (%) | ||||
| Depleted/nondepleted | 15/84 | 13/86 | 13/86 | 12/86 |
| Conditioning regimen (%) | ||||
| Chemotherapy | 32 | 35 | 32 | 35 |
| Single TBI + chemo | 17 | 15 | 17 | 14 |
| Fract TBI + chemo | 46 | 49 | 48 | 49 |
| Other | 3 | 0 | 2 | 0 |
| Unknown | 2 | 1 | 1 | 1 |
| Underlying disease (%) | ||||
| Acute myeloblastic leukemia | 32 | 27 | 30 | 26 |
| Acute lymphoblastic leukemia | 17 | 16 | 18 | 16 |
| Chronic myelogenous leukemia/chronic granulocytic leukemia | 30 | 30 | 32 | 31 |
| Aplastic anemia | 4 | 4 | 3 | 4 |
| Non-Hodgkin lymphoma | 3 | 4 | 4 | 4 |
| Hodgkin lymphoma | 2 | 2 | 1 | 1 |
| Other | 12 | 16 | 12 | 16 |
| Unknown | 1 | 1 | 1 | 1 |
| Risk category (%)* | ||||
| Low | 63 | 62 | 65 | 65 |
| Intermediate | 25 | 24 | 26 | 22 |
| High | 10 | 12 | 6 | 11 |
Low indicates first remission/chronic phase; intermediate, first relapse/second or subsequent remission/accelerated phase; high, second relapse/blast crisis/primary refractory.
Oncology patients only. Safety population, n = 323 (acyclovir) and n = 333 (valacyclovir). Efficacy population, n = 263 (acyclovir) and n = 268 (valacyclovir).