G-CSF and infectious complications
| . | Intent-to-treat . | Treated-as-assigned . | ||
|---|---|---|---|---|
| No G-CSF . | G-CSF . | No G-CSF . | G-CSF . | |
| Infection-associated mortality | ||||
| AIE/HAM, no. patients | 5 | 2 | 4 | 2 |
| Life-threatening sepsis | ||||
| AIE/HAM, no. patients | 1 | 5 | 1 | 4 |
| Microbiologically documented infections, no. patients (%)* | ||||
| AIE | ||||
| Total | 27 (20.1) | 36 (24.3) | 22 (18.6) | 34 (25.2) |
| SR | 9 (17.0) | 8 (14.8) | 5 (11.4) | 8 (15.4) |
| HR | 17 (25.8) | 19 (27.5) | 16 (26.7) | 19 (29.7) |
| Down | 1 (6.7) | 9 (36.0) | 1 (7.1) | 7 (36.8) |
| HAM | ||||
| Total | 25 (20.8) | 19 (16.1) | 17 (16.3) | 17 (15.2) |
| SR | 12 (21.8) | 7 (13.5) | 6 (13.3) | 7 (13.7) |
| HR | 13 (20.0) | 12 (8.2) | 11 (18.6) | 10 (16.4) |
| Septicemia, no. patients (%) | ||||
| AIE | ||||
| Total | 23 (17.2) | 25 (16.9) | 18 (15.3) | 23 (17.0) |
| SR | 9 (17.0) | 5 (9.3) | 5 (11.4) | 5 (9.6) |
| HR | 13 (19.7) | 12 (17.4) | 12 (20.0) | 12 (18.8) |
| Down | 1 (6.7) | 8 (32.0) | 1 (7.1) | 6 (31.6) |
| HAM | ||||
| Total | 22 (18.3) | 16 (13.6) | 16 (15.4) | 15 (13.4) |
| SR | 10 (18.2) | 6 (11.5) | 5 (11.1) | 6 (11.8) |
| HR | 12 (18.5) | 10 (15.2) | 11 (18.6) | 9 (14.8) |
| Episodes of febrile neutropenia, no. patients (%)† | ||||
| AIE | ||||
| Total | 72 (51.4) | 78 (52.7) | 65 (52.4) | 69 (51.1) |
| SR | 24 (42.9) | 27 (50.0) | 21 (44.7) | 25 (48.1) |
| HR | 38 (55.9) | 39 (56.5) | 35 (56.5) | 34 (53.1) |
| Down | 10 (62.5) | 12 (48.0) | 9 (60.0) | 10 (52.6) |
| HAM | ||||
| Total | 36 (29.8) | 37 (30.8) | 32 (30.5) | 35 (31.0) |
| SR | 14 (25.0) | 15 (28.3) | 13 (28.3) | 15 (29.4) |
| HR | 22 (33.8) | 22 (32.8) | 19 (32.2) | 20 (32.3) |
| Median no. d with fever (range) | ||||
| AIE | ||||
| Total | 5 (1-35) | 5 (1-27) | 5 (1-35) | 5 (1-27) |
| SR | 4 (1-17) | 4 (1-14) | 4 (1-16) | 4 (1-14) |
| HR | 6 (1-35) | 6 (1-27) | 5.5 (1-35) | 6 (1-27) |
| Down | 8 (1-16) | 4 (1-18) | 7.5 (1-11) | 1.5 (1-13) |
| HAM | ||||
| Total | 4 (1-19) | 3 (1-21) | 3 (1-19) | 3 (1-21) |
| SR | 3 (1-19) | 3 (1-21) | 3 (1-19) | 3.5 (1-21) |
| HR | 4 (1-15) | 3 (1-16) | 3 (1-15) | 3 (1-16) |
| . | Intent-to-treat . | Treated-as-assigned . | ||
|---|---|---|---|---|
| No G-CSF . | G-CSF . | No G-CSF . | G-CSF . | |
| Infection-associated mortality | ||||
| AIE/HAM, no. patients | 5 | 2 | 4 | 2 |
| Life-threatening sepsis | ||||
| AIE/HAM, no. patients | 1 | 5 | 1 | 4 |
| Microbiologically documented infections, no. patients (%)* | ||||
| AIE | ||||
| Total | 27 (20.1) | 36 (24.3) | 22 (18.6) | 34 (25.2) |
| SR | 9 (17.0) | 8 (14.8) | 5 (11.4) | 8 (15.4) |
| HR | 17 (25.8) | 19 (27.5) | 16 (26.7) | 19 (29.7) |
| Down | 1 (6.7) | 9 (36.0) | 1 (7.1) | 7 (36.8) |
| HAM | ||||
| Total | 25 (20.8) | 19 (16.1) | 17 (16.3) | 17 (15.2) |
| SR | 12 (21.8) | 7 (13.5) | 6 (13.3) | 7 (13.7) |
| HR | 13 (20.0) | 12 (8.2) | 11 (18.6) | 10 (16.4) |
| Septicemia, no. patients (%) | ||||
| AIE | ||||
| Total | 23 (17.2) | 25 (16.9) | 18 (15.3) | 23 (17.0) |
| SR | 9 (17.0) | 5 (9.3) | 5 (11.4) | 5 (9.6) |
| HR | 13 (19.7) | 12 (17.4) | 12 (20.0) | 12 (18.8) |
| Down | 1 (6.7) | 8 (32.0) | 1 (7.1) | 6 (31.6) |
| HAM | ||||
| Total | 22 (18.3) | 16 (13.6) | 16 (15.4) | 15 (13.4) |
| SR | 10 (18.2) | 6 (11.5) | 5 (11.1) | 6 (11.8) |
| HR | 12 (18.5) | 10 (15.2) | 11 (18.6) | 9 (14.8) |
| Episodes of febrile neutropenia, no. patients (%)† | ||||
| AIE | ||||
| Total | 72 (51.4) | 78 (52.7) | 65 (52.4) | 69 (51.1) |
| SR | 24 (42.9) | 27 (50.0) | 21 (44.7) | 25 (48.1) |
| HR | 38 (55.9) | 39 (56.5) | 35 (56.5) | 34 (53.1) |
| Down | 10 (62.5) | 12 (48.0) | 9 (60.0) | 10 (52.6) |
| HAM | ||||
| Total | 36 (29.8) | 37 (30.8) | 32 (30.5) | 35 (31.0) |
| SR | 14 (25.0) | 15 (28.3) | 13 (28.3) | 15 (29.4) |
| HR | 22 (33.8) | 22 (32.8) | 19 (32.2) | 20 (32.3) |
| Median no. d with fever (range) | ||||
| AIE | ||||
| Total | 5 (1-35) | 5 (1-27) | 5 (1-35) | 5 (1-27) |
| SR | 4 (1-17) | 4 (1-14) | 4 (1-16) | 4 (1-14) |
| HR | 6 (1-35) | 6 (1-27) | 5.5 (1-35) | 6 (1-27) |
| Down | 8 (1-16) | 4 (1-18) | 7.5 (1-11) | 1.5 (1-13) |
| HAM | ||||
| Total | 4 (1-19) | 3 (1-21) | 3 (1-19) | 3 (1-21) |
| SR | 3 (1-19) | 3 (1-21) | 3 (1-19) | 3.5 (1-21) |
| HR | 4 (1-15) | 3 (1-16) | 3 (1-15) | 3 (1-16) |