Toxicities of grade 3 or 4 in 62 eligible patients receiving at least 1 dose of fenretinide
| Toxicity | ≤18 years age Dose of 2,475 mg/m2/d (n = 56) | > 18 years age Dose of 1,800 mg/m2/d (n = 6) | ||
|---|---|---|---|---|
| Number of patients | % patients | Number of patients | % patients | |
| Rash* | 1 | 1.8 | 0 | 0 |
| Diarrhea* | 1 | 1.8 | 0 | 0 |
| Nausea* | 2 | 3.6 | 0 | 0 |
| Vomiting* | 1 | 1.8 | 0 | 0 |
| Bilirubin* | 4 | 7.1 | 0 | 0 |
| AST (SGOT)* | 2 | 3.6 | 0 | 0 |
| ALT (SGPT)* | 2 | 3.6 | 0 | 0 |
| Nyctalopia* | 0 | 0 | 1 | 16.7 |
| Abdominal pain* | 3 | 5.4 | 0 | 0 |
| Catheter-related infection | 1 | 1.8 | 0 | 0 |
| Anorexia | 1 | 1.8 | 0 | 0 |
| Muscle weakness | 1 | 1.8 | 0 | 0 |
| Inner ear/hearing | 1 | 1.8 | 0 | 0 |
| Epistaxis | 1 | 1.8 | 0 | 0 |
| Bone pain | 8 | 14.3 | 0 | 0 |
| Hemoglobin | 11 | 19.6 | 1 | 16.7 |
| Dyspnea (shortness of breath) | 1 | 1.8 | 0 | 0 |
| Infection without neutropenia | 2 | 3.6 | 0 | 0 |
| Hepatic enlargement | 1 | 1.8 | 0 | 0 |
| Liver dysfunction/failure (clinical) | 1 | 1.8 | 0 | 0 |
| Leukocytes (total WBC) | 5 | 8.9 | 0 | 0 |
| Hypoxia | 1 | 1.8 | 0 | 0 |
| Weight loss | 2 | 3.6 | 0 | 0 |
| Pleural effusion (nonmalignant) | 1 | 1.8 | 0 | 0 |
| Lymphopenia | 6 | 10.7 | 0 | 0 |
| Neutrophils/granulocytes (ANC/AGC) | 5 | 8.9 | 0 | 0 |
| Platelets | 9 | 16.1 | 2 | 33.3 |
| Hypokalemia | 2 | 3.6 | 0 | 0 |
| Tumor pain | 1 | 1.8 | 0 | 0 |
| Hyponatremia | 2 | 3.6 | 0 | 0 |
| Transfusion: platelets | 5 | 8.9 | 1 | 16.7 |
| Transfusion: PRBCs | 9 | 16.1 | 1 | 16.7 |
| Pain—Other | 1 | 1.8 | 0 | 0 |
NOTE: Only the worst toxicity grade per type per patient across all courses was counted. Also, targeted toxicities are indicated by asterisk.