Table 3.
AE Category | 0 | 1 | 2 | 3 | 4 | Total |
---|---|---|---|---|---|---|
Leukopenia | 28 | 6 | 1 | 0 | 0 | 35 |
Thrombocytopenia | 33 | 2 | 0 | 0 | 0 | 35 |
Neutropenia | 33 | 1 | 1 | 0 | 0 | 35 |
Anemia | 13 | 9 | 11 | 2 | 0 | 35 |
Other Hematologic | 31 | 2 | 2 | 0 | 0 | 35 |
Allergy/Immunology | 34 | 1 | 0 | 0 | 0 | 35 |
Constitutional | 15 | 12 | 5 | 3 | 0 | 35 |
Dermatologic | 8 | 9 | 13 | 5 | 0 | 35 |
Nausea | 25 | 8 | 2 | 0 | 0 | 35 |
Vomiting | 26 | 7 | 1 | 1 | 0 | 35 |
Gastrointestinal | 19 | 9 | 3 | 4 | 0 | 35 |
Hemorrhage | 34 | 1 | 0 | 0 | 0 | 35 |
Infection | 31 | 0 | 2 | 2 | 0 | 35 |
Metabolic | 22 | 8 | 4 | 1 | 0 | 35 |
Musculoskeletal | 33 | 1 | 1 | 0 | 0 | 35 |
Neurological | 33 | 1 | 0 | 1 | 0 | 35 |
Ocular/Visual | 33 | 1 | 1 | 0 | 0 | 35 |
Pain | 25 | 4 | 4 | 2 | 0 | 35 |
Pulmonary | 30 | 4 | 0 | 1 | 0 | 35 |
Vascular | 33 | 0 | 0 | 2 | 0 | 35 |
One patient death reported by an institution was listed as due to disease. The DSMB listed her death as due to disease and possibly treatment. She had grade 4 pain with hematuria.