Table 4.
Toxicities of 144 CML-CP patients who received assigned therapy, by treatment arm
| IM400 (N=72) | IM800 (N=72) | P* | |||
|---|---|---|---|---|---|
| All grades | Grade 3–4 | All grades | Grade 3–4 | ||
| Haematologic toxicities | |||||
| Hemoglobin | 47 (65%) | 5 ( 7%) | 59 (82%) | 8 (11%) | 0.0067 |
| Neutrophils | 23 (32%) | 8 (11%) | 33 (46%) | 12 (17%) | 0.043 |
| Febrile neutropenia | 1 ( 1%) | 1 ( 1%) | 1 ( 1%) | 1 ( 1%) | 0.75 |
| Platelets | 24 (33%) | 6 ( 8%) | 46 (64%) | 14 (19%) | <0.0001 |
|
| |||||
| Fluid retention | |||||
| Edema (any) | 42 (58%) | 3 ( 4%) | 50 (69%) | 2 ( 3%) | 0.15 |
| Pleural effusion | 0 ( 0%) | 0 ( 0%) | 2 ( 3%) | 0 ( 0%) | 0.25 |
|
| |||||
| Gastrointestinal toxicities | |||||
| Diarrhea | 28 (39%) | 1 ( 1%) | 40 (56%) | 6 ( 8%) | 0.0088 |
| Nausea | 36 (50%) | 2 ( 3%) | 42 (58%) | 2 ( 3%) | 0.043 |
| Vomiting | 11 (15%) | 1 ( 1%) | 20 (28%) | 0 ( 0%) | 0.036 |
| Anorexia | 11 (15%) | 0 ( 0%) | 16 (22%) | 0 ( 0%) | 0.16 |
|
| |||||
| Other non-haematologic toxicities | |||||
| Fatigue | 47 (65%) | 0 ( 0%) | 57 (79%) | 11 (15%) | 0.0006 |
| Musculoskeletal pain (any) | 33 (46%) | 2 ( 3%) | 42 (58%) | 8 (11%) | 0.011 |
| Rash | 19 (26%) | 1 ( 1%) | 36 (50%) | 4 ( 6%) | 0.0012 |
| Headache | 9 (13%) | 1 ( 1%) | 9 (13%) | 1 ( 1%) | 0.49 |
| Prolonged QTc interval | 3 ( 4%) | 0 ( 0%) | 7 (10%) | 0 ( 0%) | 0.14 |
*
One sided p-value for higher AE grades in the IM800 arm, based on Wilcoxon test.