Laboratory abnormalities in patients with bleeding and ICANS
| Laboratory findings . | Total . | Bleeding . | P . | ICANS Max Grade . | P . | ||
|---|---|---|---|---|---|---|---|
| Evaluable . | Yes (n = 12) . | No (n = 115) . | 0-2 (n = 104) . | 3-4 (n = 23) . | |||
| Coagulation parameters | |||||||
| Prothrombin time (PT), n (%) | 96 (75.6) | — | — | .02 | — | — | .01 |
| 0-3-s prolongation | — | 7 (63.6) | 78 (91.8) | 70 (93.3) | 15 (71.4) | — | |
| >3-s prolongation | — | 4 (36.4) | 7 (8.2) | 5 (6.7) | 6 (28.6) | — | |
| PTT prolongation, n (%) | 74 (58.3) | — | — | >.99 | — | — | .36 |
| 0-5 s prolongation | — | 8 (80) | 47 (73.4) | — | 39 (70.9) | 16 (84.2) | — |
| >5 s prolongation | — | 2 (20) | 17 (26.6) | — | 16 (29.1) | 3 (15.8) | — |
| TT prolongation, n (%) | 58 (45.7) | 7 (70) | 19 (39.6) | .10 | 14 (31.8) | 12 (85.7) | <.01 |
| D-dimer elevation, n (%) | 61 (48) | — | — | >.99 | — | — | .19 |
| 0-3 x ULN | — | 3 (30) | 14 (27.5) | — | 15 (33.3) | 2 (12.5) | — |
| >3 x ULN | — | 7 (70) | 37 (72.5) | — | 30 (66.7) | 14 (87.5) | — |
| D-dimer peak, μg/mL, median (range) | 2.56 (0.77-20) | 3.76 (0.82-20) | 2.32 (0.77-20) | .48 | 2.22 (0.77-20) | 4.28 (0.87-20) | .02 |
| Platelet nadir, ×103/μL, median (range) | 40 (5-158) | 17.5 (6-52) | 48 (5-158) | <.01 | 53.5 (5-158) | 17 (9-75) | <.01 |
| Fibrinogen nadir, mg/dL, median (range) | 307.5 (66-1057) | 122 (66-589) | 340 (78-1057) | <.01 | 346 (78-1057) | 114.5 (66-939) | <.01 |
| ISTH DIC score ≥5, n (%) | 61 (48) | 5 (50) | 18 (35.3) | .48 | 14 (31.1) | 9 (56.3) | .13 |
| Inflammatory markers | |||||||
| Ferritin peak, ng/mL, median (range) | 1393 (84-65 881) | 2523 (652-65 881) | 1307 (84-62 092) | .01 | 1314 (84-62 092) | 1667 (560-65 881) | .07 |
| CRP peak, mg/dL, median (range) | 7.6 (0.4-60) | 12.7 (4-38) | 7.6 (0.4-60) | .15 | 7.4 (0.4-60) | 13.3 (2.4-60) | .01 |
| Laboratory findings . | Total . | Bleeding . | P . | ICANS Max Grade . | P . | ||
|---|---|---|---|---|---|---|---|
| Evaluable . | Yes (n = 12) . | No (n = 115) . | 0-2 (n = 104) . | 3-4 (n = 23) . | |||
| Coagulation parameters | |||||||
| Prothrombin time (PT), n (%) | 96 (75.6) | — | — | .02 | — | — | .01 |
| 0-3-s prolongation | — | 7 (63.6) | 78 (91.8) | 70 (93.3) | 15 (71.4) | — | |
| >3-s prolongation | — | 4 (36.4) | 7 (8.2) | 5 (6.7) | 6 (28.6) | — | |
| PTT prolongation, n (%) | 74 (58.3) | — | — | >.99 | — | — | .36 |
| 0-5 s prolongation | — | 8 (80) | 47 (73.4) | — | 39 (70.9) | 16 (84.2) | — |
| >5 s prolongation | — | 2 (20) | 17 (26.6) | — | 16 (29.1) | 3 (15.8) | — |
| TT prolongation, n (%) | 58 (45.7) | 7 (70) | 19 (39.6) | .10 | 14 (31.8) | 12 (85.7) | <.01 |
| D-dimer elevation, n (%) | 61 (48) | — | — | >.99 | — | — | .19 |
| 0-3 x ULN | — | 3 (30) | 14 (27.5) | — | 15 (33.3) | 2 (12.5) | — |
| >3 x ULN | — | 7 (70) | 37 (72.5) | — | 30 (66.7) | 14 (87.5) | — |
| D-dimer peak, μg/mL, median (range) | 2.56 (0.77-20) | 3.76 (0.82-20) | 2.32 (0.77-20) | .48 | 2.22 (0.77-20) | 4.28 (0.87-20) | .02 |
| Platelet nadir, ×103/μL, median (range) | 40 (5-158) | 17.5 (6-52) | 48 (5-158) | <.01 | 53.5 (5-158) | 17 (9-75) | <.01 |
| Fibrinogen nadir, mg/dL, median (range) | 307.5 (66-1057) | 122 (66-589) | 340 (78-1057) | <.01 | 346 (78-1057) | 114.5 (66-939) | <.01 |
| ISTH DIC score ≥5, n (%) | 61 (48) | 5 (50) | 18 (35.3) | .48 | 14 (31.1) | 9 (56.3) | .13 |
| Inflammatory markers | |||||||
| Ferritin peak, ng/mL, median (range) | 1393 (84-65 881) | 2523 (652-65 881) | 1307 (84-62 092) | .01 | 1314 (84-62 092) | 1667 (560-65 881) | .07 |
| CRP peak, mg/dL, median (range) | 7.6 (0.4-60) | 12.7 (4-38) | 7.6 (0.4-60) | .15 | 7.4 (0.4-60) | 13.3 (2.4-60) | .01 |
Frequency of treatment-emergent abnormal laboratory values and median nadir or peak values in patients with bleeding, and ICANS grades 0-2 vs grades 3-4. Total evaluable represents the total number (for categorical variables) or median value (for continuous variables) from patients with available data for analysis. Patients without data available were excluded from the analysis. Normal range for D-dimer was <0.50 μg/mL fibrinogen-equivalent units. ISTH DIC score includes platelets (>100 = 0, 50-100 = 1, and <50 = 2), PT prolongation (< 3 s = 0< 3 s to <6 s = 1, ≥6 s = 2), D-dimer (0, no increase, <5 times ULN = 2, ≥5 times ULN = 3), and fibrinogen (>100 μg/mL = 0, ≤100 μg/mL=1) and a score ≥5 is suggestive of overt DIC. P for categorical variables was calculated by Fisher’s exact test and for continuous variables by the Mann-Whitney U test. P values in bold are .05 or less.