TABLE 2.
Selected Adverse Events (Grade 2-4) on S0312
| Adverse Event | Grade 2 (Moderate)# | Grade 3 (Severe) | Grade 4 (Life threatening) |
|---|---|---|---|
| Number of patients (%) | Number of patients (%) | Number of patients (%) | |
| Blood/Bone Marrow | |||
| Hemoglobin | 12 | 3 | 0 |
| Leukocytes | 10 | 4 | 1 |
| Lymphopenia | 8 | 0 | 1 |
| Neutrophils | 8 | 12 | 1 |
| Platelets | 4 | 0 | 1 |
| Hemolysis | 0 | 0 | 1 |
| Cardiovascular | |||
| Cardiac Ischemia/infarction | 0 | 1 | 0 |
| Thrombosis/embolism(vascular accident) | 1 | 0 | 0 |
| Thrombosis/embolism | 1 | 1 | 0 |
| Phlebitis | 2 | 0 | 0 |
| Constitutional Symptoms | |||
| Fatigue | 16 | 5 | 1 |
| Weight Loss | 2 | 0 | 0 |
| Sweating | 2 | 0 | 0 |
| Fever | 3 | 0 | 0 |
| Insomnia | 2 | 0 | 0 |
| Dermatology/Skin | |||
| Rash: hand-foot skin reaction | 5 | 2 | 0 |
| Gastrointestinal | |||
| Diarrhea | 4 | 1 | 0 |
| Anorexia | 8 | 0 | 0 |
| Nausea | 4 | 2 | 0 |
| Vomiting | 4 | 2 | 0 |
| Mucositis (Oral) | 1 | 1 | 0 |
| Dehydration | 2 | 0 | 0 |
| Heartburn | 1 | 1 | 0 |
| Metabolic/Laboratory | |||
| AST | 2 | 0 | 0 |
| Hyperglycemia | 1 | 1 | 0 |
| Hypoalbuminemia | 5 | 0 | 0 |
| Hypokalemia | 0 | 2 | 0 |
| Neurology/Musculoskeletal | |||
| Neuro Pain: head/headache | 1 | 1 | 0 |
| Musculoskeletal-other | 0 | 1 | 0 |
| Pulmonary | |||
| Cough | 2 | 0 | 0 |
| Lung Pain: chest/thorax | 2 | 0 | 0 |
| Dyspnea | 0 | 1 | 0 |
| Renal | |||
| Renal failure | 0 | 0 | 1 |
| Maximum grade of any adverse event | |||
| Number | 9 | 26 | 4 |
#
Grade 2 toxicities with only one reported adverse event and no grade 3 or 4 events were excluded.