Table 2.
The number of AESIs by arfolitixorin dose and AE grade according to CTCAE Version 4.0
| Arfolitixorin dose mg/m2 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|
| 30 |
60 |
120 |
240 |
Total | |||||
| AESI | Grade 1/2 | Grade ≥3 | Grade 1/2 | Grade ≥3 | Grade 1/2 | Grade ≥3 | Grade 1/2 | Grade ≥3 | |
| Neutropenia | — | 5 | 5 | 6 | 7 | 7 | — | — | 30 |
| Leukopenia | — | — | — | 1 | 5 | — | — | — | 6 |
| Increased creatinine | — | — | — | — | 4 | 2 | — | — | 6 |
| Nausea | — | — | — | — | 3 | 2 | — | — | 5 |
| Vomiting | — | — | — | — | 3 | 2 | — | — | 5 |
| Fatigue | 1 | — | — | 1 | 1 | 1 | — | 1 | 5 |
| Thrombocytopenia | — | — | — | — | 3 | 1 | — | — | 4 |
| Anemia | — | — | 1 | — | 2 | — | — | — | 3 |
| Diarrhea | — | — | 1 | — | 1 | 1 | — | — | 3 |
| Febrile neutropenia | — | — | — | 1 | — | 1 | — | — | 2 |
| Dehydration | — | — | — | — | — | 2 | — | — | 2 |
| Hyponatremia | — | — | — | — | — | 2 | — | — | 2 |
| Ileitis | — | — | — | — | — | 1 | — | — | 1 |
| Infection | — | — | — | — | — | — | — | 1 | 1 |
| Mesenteric vein thrombosis | — | 1 | — | — | — | — | — | — | 1 |
| Acute renal failure | — | — | — | — | — | 1 | — | — | 1 |
| Low platelet count | — | — | — | — | 1 | — | — | — | 1 |
| Abdominal pain | — | — | — | — | — | 1 | — | — | 1 |
| Pancolitis | — | — | — | — | — | 1 | — | — | 1 |
| Syncope | — | — | — | — | — | 1 | — | — | 1 |
| Progression of pre-existing cancer | — | — | — | — | — | 1 | — | — | 1 |
| 82 | |||||||||
AE, adverse event; AESI, adverse event of special interest; CTCAE, Common Terminology Criteria for Adverse Events.