Baseline demographic and disease characteristics
. | . | Palifermin . | . | . | . | . | . | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| . | . | Cohort 1 . | . | Cohort 2 . | Cohort 3 . | . | . | ||||
. | Placebo . | 40 μg/kg or 240 μg/kg total dose . | 60 μg/kg or 360 μg/kg total dose . | 60 μg/kg or 540 μg/kg total dose . | 60 μg/kg or 720 μg/kg total dose . | All patients . | P* . | ||||
| Randomized, no. | 31 | 8 | 10 | 14 | 37 | 69 | |||||
| Center, no. (%) | |||||||||||
| Michigan | 14 (45) | 3 (37) | 4 (40) | 7 (50) | 18 (49) | 32 (46) | .91 | ||||
| Minnesota | 17 (55) | 5 (63) | 6 (60) | 7 (50) | 19 (51) | 37 (54) | |||||
| Sex, no. (%) | |||||||||||
| Male | 18 (58) | 6 (75) | 6 (60) | 10 (71) | 18 (49) | 40 (58) | .99 | ||||
| Female | 13 (42) | 2 (25) | 4 (40) | 4 (29) | 19 (51) | 29 (42) | |||||
| Median age, y (range) | 46 (7-63) | 44 (33-64) | 43.5 (24-55) | 48.5 (22-60) | 47 (7-65) | 46 (7-65) | .58 | ||||
| Median weight, kg (range) | 78 (25-159) | 73 (64-96) | 76 (50-119) | 92 (48-124) | 82 (26-114) | 81 (26-124) | .74 | ||||
| Disease, no. (%) | |||||||||||
| AII | 1 (3) | 0 | 1 (10) | 3 (21) | 4 (11) | 8 (12) | .08 | ||||
| AML | 12 (39) | 4 (50) | 3 (30) | 6 (42) | 11 (30) | 24 (35) | |||||
| CML | 8 (26) | 2 (25) | 2 (20) | 1 (7) | 2 (5) | 7 (10) | |||||
| MDS | 6 (19) | 0 | 0 | 1 (7) | 5 (14) | 6 (9) | |||||
| NHL | 1 (3) | 1 (13) | 0 | 3 (21) | 9 (24) | 13 (19) | |||||
| Hodgkin | 0 | 0 | 1 (10) | 0 | 0 | 1 (1) | |||||
| Other malignancies | 3 (10) | 1 (13) | 3 (30) | 0 | 6 (17) | 10 (14) | |||||
. | . | Palifermin . | . | . | . | . | . | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| . | . | Cohort 1 . | . | Cohort 2 . | Cohort 3 . | . | . | ||||
. | Placebo . | 40 μg/kg or 240 μg/kg total dose . | 60 μg/kg or 360 μg/kg total dose . | 60 μg/kg or 540 μg/kg total dose . | 60 μg/kg or 720 μg/kg total dose . | All patients . | P* . | ||||
| Randomized, no. | 31 | 8 | 10 | 14 | 37 | 69 | |||||
| Center, no. (%) | |||||||||||
| Michigan | 14 (45) | 3 (37) | 4 (40) | 7 (50) | 18 (49) | 32 (46) | .91 | ||||
| Minnesota | 17 (55) | 5 (63) | 6 (60) | 7 (50) | 19 (51) | 37 (54) | |||||
| Sex, no. (%) | |||||||||||
| Male | 18 (58) | 6 (75) | 6 (60) | 10 (71) | 18 (49) | 40 (58) | .99 | ||||
| Female | 13 (42) | 2 (25) | 4 (40) | 4 (29) | 19 (51) | 29 (42) | |||||
| Median age, y (range) | 46 (7-63) | 44 (33-64) | 43.5 (24-55) | 48.5 (22-60) | 47 (7-65) | 46 (7-65) | .58 | ||||
| Median weight, kg (range) | 78 (25-159) | 73 (64-96) | 76 (50-119) | 92 (48-124) | 82 (26-114) | 81 (26-124) | .74 | ||||
| Disease, no. (%) | |||||||||||
| AII | 1 (3) | 0 | 1 (10) | 3 (21) | 4 (11) | 8 (12) | .08 | ||||
| AML | 12 (39) | 4 (50) | 3 (30) | 6 (42) | 11 (30) | 24 (35) | |||||
| CML | 8 (26) | 2 (25) | 2 (20) | 1 (7) | 2 (5) | 7 (10) | |||||
| MDS | 6 (19) | 0 | 0 | 1 (7) | 5 (14) | 6 (9) | |||||
| NHL | 1 (3) | 1 (13) | 0 | 3 (21) | 9 (24) | 13 (19) | |||||
| Hodgkin | 0 | 0 | 1 (10) | 0 | 0 | 1 (1) | |||||
| Other malignancies | 3 (10) | 1 (13) | 3 (30) | 0 | 6 (17) | 10 (14) | |||||
AML indicates acute myelogenous leukemia; CML, chronic myelogenous leukemia; MDS, myelodysplastic syndrome; NHL, non-Hodgkin lymphoma.
P values for significance test represent all palifermin versus placebo.