TABLE 1.
Intent-to-treat population parameter | Result with:
|
|
---|---|---|
Itraconazole | Amphotericin B | |
Patient and disease characteristics at the start of treatment | ||
No. of patients randomized (male/female) | 281 (167/114) | 276 (147/129) |
Age; median (minimum–maximum) yr | 48 (15–75) | 49.5 (17–82) |
Underlying disease; n (%) | ||
Acute myeloid leukemia | 166 (59) | 153 (55) |
Acute lymphatic leukemia | 33 (12) | 42 (15) |
Other | 83 (29) | 81 (29) |
Therapy of underlying disease; n (%) | ||
Chemotherapy | 232 (89) | 221 (88) |
Bone marrow transplant | 14 (5) | 13 (5) |
Other | 14 (5) | 16 (6) |
Not recorded | 21 | 26 |
Status of disease; n (%) | ||
First treatment | 188 (79) | 184 (76) |
Other | 51 (21) | 58 (24) |
Not recorded | 42 | 34 |
Duration of neutropenia and duration of prophylactic treatment | ||
Duration of neutropenia of <0.5 × 109/liter; median (minimum–maximum) days | 18 (0–84) | 20 (0–88) |
Use of G-CSF | 83 | 81 |
Duration of prophylactic treatment; median (minimum–maximum) days | 19 (1–56) | 18 (2–56) |