Patient Characteristics, Distribution of Known Risk Factors, and Endpoints of the Study
| . | Group A With Inhalations (n = 227) . | Group B Without Inhalations (n = 155) . |
|---|---|---|
| Age in years | ||
| Mean (range) | 46 (16-80) | 48 (17-81) |
| Disease category | ||
| AML/MDS/CML | 165 (73%) | 118 (76%) |
| ALL/NHL | 23 (10%) | 12 (8%) |
| Auto-BMT | 39 (17%) | 25 (16%) |
| Inadequate inclusions | 8 (4%) | 6 (4%) |
| Risk factors for IA infections | ||
| Neutropenia <0.5/nL at study entry | 79 (35%) | 48 (31%) |
| Building reconstruction activity | 49 (22%) | 36 (23%) |
| Steroid comedication | 29 (13%) | 20 (13%) |
| Growth factor (G-CSF/GM-CSF)* | 108 (48%) | 54 (35%) |
| Neutropenia <0.5/nL | ||
| Median (range) | 19 (0-50) | 21 (0-50) |
| Days in study | ||
| Median (range) | 27 (2-50) | 28 (0-50) |
| Study endpoint reached | ||
| Neutrophil recovery >1.0/nL | 171 (75%) | 120 (77%) |
| No neutrophils until day +50 | 28 (12%) | 18 (12%) |
| No neutropenia | 4 (2%) | 5 (3%) |
| Death before neutrophil recovery | 24 (11%) | 12 (8%) |
| . | Group A With Inhalations (n = 227) . | Group B Without Inhalations (n = 155) . |
|---|---|---|
| Age in years | ||
| Mean (range) | 46 (16-80) | 48 (17-81) |
| Disease category | ||
| AML/MDS/CML | 165 (73%) | 118 (76%) |
| ALL/NHL | 23 (10%) | 12 (8%) |
| Auto-BMT | 39 (17%) | 25 (16%) |
| Inadequate inclusions | 8 (4%) | 6 (4%) |
| Risk factors for IA infections | ||
| Neutropenia <0.5/nL at study entry | 79 (35%) | 48 (31%) |
| Building reconstruction activity | 49 (22%) | 36 (23%) |
| Steroid comedication | 29 (13%) | 20 (13%) |
| Growth factor (G-CSF/GM-CSF)* | 108 (48%) | 54 (35%) |
| Neutropenia <0.5/nL | ||
| Median (range) | 19 (0-50) | 21 (0-50) |
| Days in study | ||
| Median (range) | 27 (2-50) | 28 (0-50) |
| Study endpoint reached | ||
| Neutrophil recovery >1.0/nL | 171 (75%) | 120 (77%) |
| No neutrophils until day +50 | 28 (12%) | 18 (12%) |
| No neutropenia | 4 (2%) | 5 (3%) |
| Death before neutrophil recovery | 24 (11%) | 12 (8%) |
Probability of P < .05 for the difference between the two groups; all other comparisons between the two groups had probabilities of P > .05.