| SOC (n = 21) | Im + SOC (n = 20) | |||||
|---|---|---|---|---|---|---|
| Adverse event | Patients numbers with severity ≥1 | Average severity score | Imatinib related | Patients numbers with severity ≥1 | Average severity score | Imatinib related |
| Itching/skin reaction/rash | 0 (0%) | 0 (0; 0–0) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| Edema | 0 (0%) | 0 (0; 0–0) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| Fever | 21 (100%) | 2.4 (0.74; 1–3) | NA | 20 (100%) | 2.2 (0.67; 1–3) | 0 (0; 0–0) |
| Headache | 4 (19.0%) | 0.2 (0.40; 0–1) | NA | 3 (15.0%) | 0.2 (0.37; 0–1) | 0 (0; 0–0) |
| Body aches/pain | 0 (0%) | 0 (0; 0–0) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| Nausea | 0 (0%) | 0 (0; 0–0) | NA | 1 (5.0%) | 0.05 (0.22; 0–1) | 0 (0; 0–0) |
| Vomiting | 0 (0%) | 0 (0; 0–0) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| Diarrhea | 2 (9.5%) | 0.10 (0.30; 0–1) | NA | 2 (10.0%) | 0.10 (0.31; 0–1) | 0 (0; 0–0) |
| Anemia | 2 (9.5%) | 0.10 (0.30; 0–1) | NA | 1 (10.0%) | 0.05 (0.22; 0–1) | 0 (0; 0–0) |
| Jaundice | 1 (4.8%) | 0.05 (0.22; 0–1) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| SOC ( | Im + SOC ( | |||||
|---|---|---|---|---|---|---|
| Adverse event | Patients numbers with severity ≥1 | Average severity score | Imatinib related | Patients numbers with severity ≥1 | Average severity score | Imatinib related |
| Itching/skin reaction/rash | 0 (0%) | 0 (0; 0–0) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| Edema | 0 (0%) | 0 (0; 0–0) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| Fever | 21 (100%) | 2.4 (0.74; 1–3) | NA | 20 (100%) | 2.2 (0.67; 1–3) | 0 (0; 0–0) |
| Headache | 4 (19.0%) | 0.2 (0.40; 0–1) | NA | 3 (15.0%) | 0.2 (0.37; 0–1) | 0 (0; 0–0) |
| Body aches/pain | 0 (0%) | 0 (0; 0–0) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| Nausea | 0 (0%) | 0 (0; 0–0) | NA | 1 (5.0%) | 0.05 (0.22; 0–1) | 0 (0; 0–0) |
| Vomiting | 0 (0%) | 0 (0; 0–0) | NA | 0 (0%) | 0 (0; 0–0) | NA |
| Diarrhea | 2 (9.5%) | 0.10 (0.30; 0–1) | NA | 2 (10.0%) | 0.10 (0.31; 0–1) | 0 (0; 0–0) |
| Anemia | 2 (9.5%) | 0.10 (0.30; 0–1) | NA | 1 (10.0%) | 0.05 (0.22; 0–1) | 0 (0; 0–0) |
| Jaundice | 1 (4.8%) | 0.05 (0.22; 0–1) | NA | 0 (0%) | 0 (0; 0–0) | NA |
Data are presented as n (%) or mean (SD; range). Severity score of 0, 1, 2, and 3 represent normal, mild, moderate, and severe, respectively (see Table S3 for additional information). NA, not applicable.
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