Baseline characteristics of patients
| Trial . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| . | APML3 (N = 101) . | APML4 (N = 124) . | C9710 (N = 481) . | E2491 (N = 198) . | S0521 (N = 105) . | . | |||||
| . | N . | . | N . | . | N . | . | N . | . | N . | . | P value . |
| Age, y | |||||||||||
| Median (range) | 101 | 41 (19-73) | 124 | 45 (3-79) | 481 | 42 (15-81) | 198 | 39 (1-81) | 105 | 49 (20-82) | <.001 |
| Sex, N (%) | |||||||||||
| Male | 53 (52.5) | 62 (50) | 247 (51.4) | 97 (49) | 61 (58.1) | .65 | |||||
| Female | 48 (47.5) | 62 (50) | 234 (48.6) | 101 (51) | 44 (41.9) | ||||||
| WBC count, 1000 cells/μL | |||||||||||
| Median (range) | 101 | 2.4 (0.4-109) | 124 | 2.4 (0.1-85.8) | 473 | 2.3 (0.2-139) | 196 | 2.2 (0.3-550) | 105 | 1.4 (0.3-12.4) | <.001 |
| WBC count, 1000 cells/μL (grouped) | |||||||||||
| Low risk (<20) | 86 (85.1) | 110 (88.7) | 400 (84.6) | 169 (86.2) | 105 (100) | <.001 | |||||
| High risk (≥20) | 15 (14.9) | 14 (11.3) | 73 (15.4) | 27 (13.8) | 0 (0) | ||||||
| PT, s | |||||||||||
| Median (range) | 82 | 15.5 (11.1-306) | 102 | 16.0 (10.0-25.0) | 465 | 14.7 (0.9-82.4) | 188 | 13.8 (10.3-71.0) | 0 | <.001 | |
| Peripheral blast count, 1000 cells/μL | |||||||||||
| Median (range) | 90 | 0.3 (0.0-79.9) | 101 | 0.6 (0.0-81.0) | 420 | 0.1 (0.0-134) | 170 | 0.2 (0.0-303) | 89 | 0.0 (0.0-11.6) | <.001 |
| PTT, s | |||||||||||
| Median (range) | 101 | 29.0 (21.0-50.0) | 124 | 28.5 (20.0-56.0) | 469 | 28.0 (17.0-363) | 188 | 27.2 (17.7-81.0) | 0 | .005 | |
| Fibrinogen | |||||||||||
| Median (range) | 97 | 180 (40.0-570) | 120 | 170 (50.0-630) | 456 | 35.0 (14.0-370) | 188 | 187 (51.0-660) | 0 | <.001 | |
| Platelet count, 1000 cells/μL | |||||||||||
| Median (range) | 101 | 24.0 (4.0-180) | 123 | 22.0 (2.0-173) | 474 | 30.0 (1.0-232) | 196 | 36.0 (5.0-587) | 105 | 35.0 (5.0-237) | <.001 |
| Platelet count, 1000 cells/μL (grouped) | |||||||||||
| Low risk (≥30) | 45 (44.6) | 49 (39.8) | 238 (50.2) | 124 (63.3) | 59 (56.2) | <.001 | |||||
| High risk (<30) | 56 (55.4) | 74 (60.2) | 236 (49.8) | 72 (36.7) | 46 (43.8) | ||||||
| Hemoglobin, g/dL | |||||||||||
| Median (range) | 101 | 9.5 (4.1-15.2) | 124 | 9.4 (5.0-14.6) | 470 | 9.3 (4.3-92.0) | 196 | 9.4 (2.1-16.4) | 105 | 8.9 (5.9-25.9) | .36 |
| Creatinine clearance, mL/min | |||||||||||
| Median (range) | 101 | 91.6 (56.8-155) | 124 | 91.8 (36.2-217) | 461 | 97.8 (7.0-864) | 183 | 90.6 (8.0-219) | 0 | 0.017 | |
| Performance status | |||||||||||
| Good (0-2) | 97 (96) | 118 (95.2) | 446 (94.7) | 178 (90.8) | 102 (97.1) | .19 | |||||
| Poor (3-4) | 4 (4) | 6 (4.8) | 25 (5.3) | 18 (9.2) | 3 (2.9) | ||||||
| FAB classification | |||||||||||
| M3 | 81 (80.2) | 99 (79.8) | 382 (85.1) | 34 (72.3) | 0 (0) | .09 | |||||
| M3v | 20 (19.8) | 25 (20.2) | 67 (14.9) | 13 (27.7) | 0 (0) | ||||||
| Trial . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| . | APML3 (N = 101) . | APML4 (N = 124) . | C9710 (N = 481) . | E2491 (N = 198) . | S0521 (N = 105) . | . | |||||
| . | N . | . | N . | . | N . | . | N . | . | N . | . | P value . |
| Age, y | |||||||||||
| Median (range) | 101 | 41 (19-73) | 124 | 45 (3-79) | 481 | 42 (15-81) | 198 | 39 (1-81) | 105 | 49 (20-82) | <.001 |
| Sex, N (%) | |||||||||||
| Male | 53 (52.5) | 62 (50) | 247 (51.4) | 97 (49) | 61 (58.1) | .65 | |||||
| Female | 48 (47.5) | 62 (50) | 234 (48.6) | 101 (51) | 44 (41.9) | ||||||
| WBC count, 1000 cells/μL | |||||||||||
| Median (range) | 101 | 2.4 (0.4-109) | 124 | 2.4 (0.1-85.8) | 473 | 2.3 (0.2-139) | 196 | 2.2 (0.3-550) | 105 | 1.4 (0.3-12.4) | <.001 |
| WBC count, 1000 cells/μL (grouped) | |||||||||||
| Low risk (<20) | 86 (85.1) | 110 (88.7) | 400 (84.6) | 169 (86.2) | 105 (100) | <.001 | |||||
| High risk (≥20) | 15 (14.9) | 14 (11.3) | 73 (15.4) | 27 (13.8) | 0 (0) | ||||||
| PT, s | |||||||||||
| Median (range) | 82 | 15.5 (11.1-306) | 102 | 16.0 (10.0-25.0) | 465 | 14.7 (0.9-82.4) | 188 | 13.8 (10.3-71.0) | 0 | <.001 | |
| Peripheral blast count, 1000 cells/μL | |||||||||||
| Median (range) | 90 | 0.3 (0.0-79.9) | 101 | 0.6 (0.0-81.0) | 420 | 0.1 (0.0-134) | 170 | 0.2 (0.0-303) | 89 | 0.0 (0.0-11.6) | <.001 |
| PTT, s | |||||||||||
| Median (range) | 101 | 29.0 (21.0-50.0) | 124 | 28.5 (20.0-56.0) | 469 | 28.0 (17.0-363) | 188 | 27.2 (17.7-81.0) | 0 | .005 | |
| Fibrinogen | |||||||||||
| Median (range) | 97 | 180 (40.0-570) | 120 | 170 (50.0-630) | 456 | 35.0 (14.0-370) | 188 | 187 (51.0-660) | 0 | <.001 | |
| Platelet count, 1000 cells/μL | |||||||||||
| Median (range) | 101 | 24.0 (4.0-180) | 123 | 22.0 (2.0-173) | 474 | 30.0 (1.0-232) | 196 | 36.0 (5.0-587) | 105 | 35.0 (5.0-237) | <.001 |
| Platelet count, 1000 cells/μL (grouped) | |||||||||||
| Low risk (≥30) | 45 (44.6) | 49 (39.8) | 238 (50.2) | 124 (63.3) | 59 (56.2) | <.001 | |||||
| High risk (<30) | 56 (55.4) | 74 (60.2) | 236 (49.8) | 72 (36.7) | 46 (43.8) | ||||||
| Hemoglobin, g/dL | |||||||||||
| Median (range) | 101 | 9.5 (4.1-15.2) | 124 | 9.4 (5.0-14.6) | 470 | 9.3 (4.3-92.0) | 196 | 9.4 (2.1-16.4) | 105 | 8.9 (5.9-25.9) | .36 |
| Creatinine clearance, mL/min | |||||||||||
| Median (range) | 101 | 91.6 (56.8-155) | 124 | 91.8 (36.2-217) | 461 | 97.8 (7.0-864) | 183 | 90.6 (8.0-219) | 0 | 0.017 | |
| Performance status | |||||||||||
| Good (0-2) | 97 (96) | 118 (95.2) | 446 (94.7) | 178 (90.8) | 102 (97.1) | .19 | |||||
| Poor (3-4) | 4 (4) | 6 (4.8) | 25 (5.3) | 18 (9.2) | 3 (2.9) | ||||||
| FAB classification | |||||||||||
| M3 | 81 (80.2) | 99 (79.8) | 382 (85.1) | 34 (72.3) | 0 (0) | .09 | |||||
| M3v | 20 (19.8) | 25 (20.2) | 67 (14.9) | 13 (27.7) | 0 (0) | ||||||
For categorical variables, numbers represent the frequency and percentage within each group, and for continuous variables, the numbers represent the median, range, and the number of patients (N) with data available that were used to make the calculation. The P values represent the results of testing differences between the trials using Fisher’s exact test for categorical variables and the Kruskal-Wallis test for continuous variables. Boldface indicates statistically significant results.