Table 4.
Change in hematology parameters relative to normal range from screening to week 24 — safety analysis set
| Parameter, n (%) | Placebo (n = 10) | IMCY-0098 dose A (n = 6) | IMCY-0098 dose B (n = 9) | IMCY-0098 dose C (n = 16) | Total (N = 41) | |
|---|---|---|---|---|---|---|
| Erythrocytes (10^12/L) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 0 | 0 | 4 (44.4) | 3 (18.8) | 7 (17.1) | |
| Change to normal or no change | 10 (100) | 6 (100) | 5 (55.6) | 13 (81.3) | 34 (82.9) | |
| Increase to high | 0 | 0 | 0 | 0 | 0 | |
| Monocytes (10^9/L) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 0 | 0 | 2 (22.2) | 0 | 2 (4.9) | |
| Change to normal or no change | 9 (90.0) | 6 (100) | 6 (66.7) | 14 (87.5) | 35 (85.4) | |
| Increase to high | 1 (10.0) | 0 | 1 (11.1) | 2 (12.5) | 4 (9.8) | |
| Lymphocytes/leukocytes (%) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 2 (20.0) | 0 | 1 (11.1) | 2 (12.5) | 5 (12.2) | |
| Change to normal or no change | 6 (60.0) | 4 (66.7) | 7 (77.8) | 12 (75.0) | 29 (70.7) | |
| Increase to high | 2 (20.0) | 2 (33.3) | 1 (11.1) | 2 (12.5) | 7 (17.1) | |
| Monocytes/leukocytes (%) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 1 (10.0) | 1 (16.7) | 0 | 0 | 2 (4.9) | |
| Change to normal or no change | 8 (80.0) | 3 (50.0) | 9 (100) | 15 (93.8) | 35 (85.4) | |
| Increase to high | 1 (10.0) | 2 (33.3) | 0 | 1 (6.3) | 4 (9.8) | |
| Granulocytes/leukocytes (%) | n [1] | 0 | 0 | 0 | 1 | 1 |
| Decrease to low | 0 | 0 | 0 | 0 | 0 | |
| Change to normal or no change | 0 | 0 | 0 | 1 (100) | 1 (100) | |
| Increase to high | 0 | 0 | 0 | 0 | 0 | |
| Neutrophile granulocytes (10^9/L) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 1 (10.0) | 1 (16.7) | 1 (11.1) | 1 (6.3) | 4 (9.8) | |
| Change to normal or no change | 7 (70.0) | 5 (83.3) | 7 (77.8) | 12 (75.0) | 31 (75.6) | |
| Increase to high | 2 (20.0) | 0 | 1 (11.1) | 3 (18.8) | 6 (14.6) | |
| Eosinophile granulocytes (10^9/L) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 1 (10.0) | 0 | 0 | 1 (6.3) | 2 (4.9) | |
| Change to normal or no change | 8 (80.0) | 6 (100) | 8 (88.9) | 14 (87.5) | 36 (87.8) | |
| Increase to high | 1 (10.0) | 0 | 1 (11.1) | 1 (6.3) | 3 (7.3) | |
| Bas. granulocytes (10^9/L) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 0 | 0 | 0 | 0 | 0 | |
| Change to normal or no change | 9 (90.0) | 4 (66.7) | 8 (88.9) | 14 (87.5) | 35 (85.4) | |
| Increase to high | 1 (10.0) | 2 (33.3) | 1 (11.1) | 2 (12.5) | 6 (14.6) | |
| Neutrophile granulocytes/leukocytes (%) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 0 | 0 | 1 (11.1) | 1 (6.3) | 2 (4.9) | |
| Change to normal or no change | 9 (90.0) | 6 (100) | 8 (88.9) | 13 (81.3) | 36 (87.8) | |
| Increase to high | 1 (10.0) | 0 | 0 | 2 (12.5) | 3 (7.3) | |
| Neutr. granulocytes/leukocytes (%) | n [1] | 0 | 2 | 0 | 1 | 3 |
| Decrease to low | 0 | 1 (50.0) | 0 | 0 | 1 (33.3) | |
| Change to normal or no change | 0 | 1 (50.0) | 0 | 1 (100) | 2 (66.7) | |
| Increase to high | 0 | 0 | 0 | 0 | 0 | |
| Eosinophile granulocytes/leukocytes (%) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 1 (10.0) | 0 | 0 | 1 (6.3) | 2 (4.9) | |
| Change to normal or no change | 7 (70.0) | 5 (83.3) | 9 (100) | 14 (87.5) | 35 (85.4) | |
| Increase to high | 2 (20.0) | 1 (16.7) | 0 | 1 (6.3) | 4 (9.8) | |
| Eosin. granulocytes/leukocytes (%) | n [1] | 0 | 2 | 0 | 1 | 3 |
| Decrease to low | 0 | 0 | 0 | 0 | 0 | |
| Change to normal or no change | 0 | 2 (100) | 0 | 1 (100) | 3 (100) | |
| Increase to high | 0 | 0 | 0 | 0 | 0 | |
| Basophile granulocytes/leukocytes (%) | n [1] | 0 | 2 | 0 | 0 | 2 |
| Decrease to low | 0 | 0 | 0 | 0 | 0 | |
| Change to normal or no change | 0 | 0 | 0 | 0 | 0 | |
| Increase to high | 0 | 2 (100) | 0 | 0 | 2 (100) | |
| Bas. granulocytes/leukocytes (%) | n [1] | 10 | 6 | 9 | 16 | 41 |
| Decrease to low | 0 | 0 | 0 | 0 | 0 | |
| Change to normal or no change | 10 (100) | 5 (83.3) | 8 (88.9) | 16 (100) | 39 (95.1) | |
| Increase to high | 0 | 1 (16.7) | 1 (11.1) | 0 | 2 (4.9) | |
| Lymphocytes atypical/leukocytes (%) | n [1] | 0 | 2 | 0 | 1 | 3 |
| Decrease to low | 0 | 0 | 0 | 0 | 0 | |
| Change to normal or no change | 0 | 0 | 0 | 0 | 0 | |
| Increase to high | 0 | 2 (100) | 0 | 1 (100) | 3 (100) | |
| Smudge cells/leukocytes (%) | n [1] | 0 | 2 | 0 | 0 | 2 |
| Decrease to low | 0 | 0 | 0 | 0 | 0 | |
| Change to normal or no change | 0 | 2 (100) | 0 | 0 | 2 (100) | |
| Increase to high | 0 | 0 | 0 | 0 | 0 |
n [1], subjects with at least one report