Table A1.
Grade III or IV Toxicities by Treatment Arm
| Toxicity Site and Type | Arm A (3 mg/m2) |
Arm B (3 mg/m2) |
Arm B (2 mg/m2) |
||||||
|---|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | ||||
| Allergy | |||||||||
| Allergic reaction/hypersensitivity | 1 | 5 | 0 | 0 | 1 | 5 | |||
| Cardiovascular (general) | |||||||||
| Hypertension | 1 | 5 | 0 | 0 | 2 | 9 | |||
| Hypotension | 2 | 10 | 0 | 0 | 1 | 5 | |||
| Coagulation | |||||||||
| Partial thromboplastin time | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Prothrombin time | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Constitutional symptoms | |||||||||
| Fever (in the absence of neutropenia) | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Dermatology/skin | |||||||||
| Rash/desquamation | 1 | 5 | 0 | 0 | 1 | 5 | |||
| Gastrointestinal | |||||||||
| Anorexia | 3 | 15 | 0 | 0 | 4 | 18 | |||
| Diarrhea (without colostomy) | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Ileus | 0 | 0 | 0 | 0 | 2 | 9 | |||
| Mucositis due to radiation | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Nausea | 2 | 10 | 0 | 0 | 2 | 9 | |||
| Pancreatitis | 0 | 0 | 1 | 33 | 1 | 5 | |||
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | 0 | 0 | 1 | 33 | 1 | 5 | |||
| Vomiting | 2 | 10 | 0 | 0 | 2 | 9 | |||
| Hemorrhage | |||||||||
| Epistaxis | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Hematemesis | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Hematuria (in the absence of vaginal bleeding) | 2 | 10 | 0 | 0 | 0 | 0 | |||
| Hemorrhage/bleeding associated with surgery | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Melena/gastrointestinal bleeding | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Vaginal bleeding | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Hepatic | |||||||||
| Alkaline phosphatase | 0 | 0 | 1 | 33 | 0 | 0 | |||
| Bilirubin | 1 | 5 | 2 | 67 | 1 | 5 | |||
| GGT | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Hypoalbuminemia | 0 | 0 | 0 | 0 | 2 | 9 | |||
| AST | 0 | 0 | 1 | 33 | 2 | 9 | |||
| ALT | 0 | 0 | 2 | 67 | 3 | 14 | |||
| Infection/febrile neutropenia | |||||||||
| Catheter-related infection | 2 | 10 | 0 | 0 | 2 | 9 | |||
| Febrile neutropenia | 6 | 30 | 0 | 0 | 7 | 32 | |||
| Infection with grade 3 or 4 neutropenia | 8 | 40 | 2 | 67 | 11 | 50 | |||
| Infection with unknown ANC | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Infection without neutropenia | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Other | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Metabolic/laboratory | |||||||||
| Amylase | 0 | 0 | 1 | 33 | 1 | 5 | |||
| Hyperglycemia | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Hyperkalemia | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Hypokalemia | 3 | 15 | 1 | 33 | 5 | 23 | |||
| Hyponatremia | 1 | 5 | 0 | 0 | 1 | 5 | |||
| Hypophosphatemia | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Lipase | 0 | 0 | 1 | 33 | 2 | 9 | |||
| Neurology | |||||||||
| Mood alteration, depression | 1 | 5 | 0 | 0 | 1 | 5 | |||
| Seizure(s) | 0 | 0 | 0 | 0 | 1 | 5 | |||
| Ocular/visual | |||||||||
| Tearing (watery eyes) | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Vision, photophobia | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Other | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Pain | |||||||||
| Abdominal pain or cramping | 1 | 5 | 0 | 0 | 1 | 5 | |||
| Headache | 0 | 0 | 0 | 0 | 2 | 9 | |||
| Other | 0 | 0 | 0 | 0 | 2 | 9 | |||
| Pulmonary | |||||||||
| Dyspnea (shortness of breath) | 1 | 5 | 0 | 0 | 1 | 5 | |||
| Hypoxia | 2 | 10 | 0 | 0 | 4 | 18 | |||
| Pneumonitis/pulmonary infiltrates | 1 | 5 | 0 | 0 | 1 | 5 | |||
| Renal | |||||||||
| Serum creatinine | 1 | 5 | 0 | 0 | 0 | 0 | |||
| Total patients | 20 | 3 | 22 | ||||||
| Patients with toxicity | 15 | 75 | 3 | 100 | 17 | 77 | |||
| Patients without toxicity | 5 | 25 | 0 | 0 | 5 | 23 | |||
Abbreviations: GGT, gamma-glutamyltransferase; ANC, absolute neutrophil count.