Table A1.
All Toxicities Attributed to Therapy
| Toxicity | Stratum I |
Stratum II |
||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade |
Total |
Grade |
Total |
|||||||||||||||
| 1 |
2 |
3 |
1 |
2 |
3 |
4 |
||||||||||||
| No. of Events | No. of Patients | No. of Events | No. of Patients | No. of Events | No. of Patients | No. of Events | No. of Patients | No. of Events | No. of Patients | No. of Events | No. of Patients | No. of Events | No. of Patients | No. of Events | No. of Patients | No. of Events | No. of Patients | |
| Diarrhea | 26 | 17 | 12 | 10 | 7 | 5 | 45 | 22 | 15 | 14 | 6 | 6 | 2 | 2 | 23 | 17 | ||
| Vomiting | 13 | 12 | 2 | 2 | 15 | 13 | 11 | 6 | 11 | 6 | ||||||||
| Nausea | 10 | 9 | 1 | 1 | 11 | 9 | 5 | 4 | 1 | 1 | 6 | 5 | ||||||
| Flatulence | 3 | 3 | 3 | 3 | ||||||||||||||
| Constipation | 1 | 1 | 1 | 1 | ||||||||||||||
| Anorexia | 3 | 3 | 1 | 1 | 4 | 4 | 2 | 2 | 1 | 1 | 3 | 3 | ||||||
| Heartburn/dyspepsia | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | ||||||||||
| Distension/bloating, abdominal | 1 | 1 | 1 | 1 | ||||||||||||||
| Mucositis/stomatitis | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | ||||||||||
| Fatigue (asthenia, lethargy, malaise) | 10 | 9 | 1 | 1 | 1 | 1 | 12 | 11 | 6 | 6 | 2 | 2 | 8 | 8 | ||||
| Weight loss | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||
| Neutrophils/granulocytes (ANC/AGC) | 2 | 1 | 1 | 1 | 3 | 2 | 2 | 1 | 2 | 2 | 1 | 1 | 5 | 4 | ||||
| Lymphopenia | 9 | 5 | 2 | 2 | 2 | 2 | 13 | 8 | 12 | 5 | 8 | 5 | 10 | 5 | 1 | 1 | 31 | 10 |
| Leukocytes (total WBC) | 7 | 5 | 7 | 5 | 10 | 5 | 3 | 3 | 2 | 2 | 15 | 7 | ||||||
| Platelets | 1 | 1 | 1 | 1 | 8 | 5 | 2 | 1 | 1 | 1 | 1 | 1 | 12 | 5 | ||||
| Hemoglobin | 9 | 8 | 2 | 2 | 11 | 10 | 9 | 7 | 5 | 2 | 2 | 1 | 16 | 7 | ||||
| Hypernatremia | 2 | 2 | 2 | 2 | ||||||||||||||
| Hyponatremia | 5 | 4 | 1 | 1 | 6 | 5 | ||||||||||||
| Hypocalcemia | 6 | 6 | 6 | 6 | ||||||||||||||
| Hypercalcemia | 1 | 1 | 1 | 1 | ||||||||||||||
| Hypokalemia | 9 | 7 | 1 | 1 | 10 | 7 | 7 | 6 | 1 | 1 | 2 | 1 | 10 | 8 | ||||
| Hyperkalemia | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | ||||||||||
| Hypophosphatemia | 3 | 3 | 3 | 3 | 8 | 6 | 2 | 2 | 10 | 8 | ||||||||
| ALT | 8 | 6 | 8 | 6 | 6 | 5 | 4 | 2 | 10 | 7 | ||||||||
| AST | 7 | 6 | 7 | 6 | 7 | 3 | 1 | 1 | 8 | 4 | ||||||||
| Hypermagnesemia | 2 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | ||||||||||
| Hypomagnesemia | 1 | 1 | 1 | 1 | ||||||||||||||
| Hyperglycemia | 2 | 2 | 2 | 2 | 5 | 5 | 5 | 5 | ||||||||||
| Hypoglycemia | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | ||||||||||
| Hypoalbuminemia | 2 | 2 | 2 | 2 | 6 | 5 | 3 | 2 | 9 | 7 | ||||||||
| Serum bicarbonate, low | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 | ||||||||||
| Hyperuricemia | 3 | 2 | 3 | 2 | ||||||||||||||
| Hyperbilirubinemia | 2 | 1 | 2 | 1 | 5 | 3 | 5 | 3 | ||||||||||
| High creatinine | 1 | 1 | 1 | 1 | ||||||||||||||
| Alkaline phosphatase | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||
| Proteinuria | 1 | 1 | 1 | 1 | ||||||||||||||
| PTT | 1 | 1 | 1 | 1 | ||||||||||||||
| Rash/desquamation | 7 | 7 | 2 | 2 | 9 | 9 | 7 | 6 | 1 | 1 | 8 | 7 | ||||||
| Rash, acne/acneiform | 2 | 2 | 3 | 3 | 1 | 1 | 6 | 5 | 3 | 2 | 3 | 2 | 1 | 1 | 7 | 3 | ||
| Pruritus/itching | 2 | 2 | 1 | 1 | 3 | 3 | ||||||||||||
| Flushing | 1 | 1 | 3 | 3 | 4 | 4 | 1 | 1 | 1 | 1 | ||||||||
| Dry skin | 2 | 2 | 2 | 2 | ||||||||||||||
| Ulceration | 1 | 1 | 1 | 1 | ||||||||||||||
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | 2 | 2 | 2 | 2 | ||||||||||||||
| Dermatology/skin, legs much cooler than rest of body | 1 | 1 | 1 | 1 | ||||||||||||||
| Dermatology/skin, local irritation | 1 | 1 | 1 | 1 | ||||||||||||||
| Hair loss/alopecia (scalp or body) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||
| Nail changes | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||
| Hematuria | 1 | 1 | 1 | 1 | ||||||||||||||
| Hemorrhage, CNS | 1 | 1 | 1 | 1 | 2 | 2 | ||||||||||||
| Hemorrhage, pulmonary/upper respiratory (nose) | 6 | 4 | 6 | 4 | 2 | 2 | 2 | 2 | ||||||||||
| Allergic reaction/hypersensitivity (including drug fever) | 1 | 1 | 1 | 1 | ||||||||||||||
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | 5 | 5 | 5 | 5 | ||||||||||||||
| Cough | 2 | 2 | 2 | 2 | 3 | 1 | 3 | 1 | ||||||||||
| Hypoxia | 1 | 1 | 1 | 1 | ||||||||||||||
| Pain (abdomen, head/headache, chest/thorax, throat/pharynx/larynx, stomach, other) | 13 | 11 | 1 | 1 | 14 | 12 | 7 | 5 | 1 | 1 | 8 | 6 | ||||||
| Edema: head and neck, limb | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | ||||||||
| Infection with normal ANC or grade 1 or 2 neutrophils | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 3 | 2 | ||||||||
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils (ANC < 1.0 × 109/L; urinary tract NOS) | 1 | 1 | 1 | 1 | ||||||||||||||
| Dizziness | 2 | 2 | 2 | 2 | ||||||||||||||
| Neuropathy: motor | 2 | 2 | 2 | 2 | ||||||||||||||
| Taste alteration (dysgeusia) | 2 | 2 | 2 | 2 | ||||||||||||||
| Seizure | 1 | 1 | 1 | 1 | ||||||||||||||
| Urinary frequency/urgency | 1 | 1 | 1 | 1 | ||||||||||||||
| Dysuria | 1 | 1 | 1 | 1 | ||||||||||||||
| Incontinence, urinary | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||
| Obstruction, genitourinary (ureter) | 1 | 1 | 1 | 1 | ||||||||||||||
| Left ventricular hypertrophy with normal function | 1 | 1 | 1 | 1 | ||||||||||||||
| Watery eye (epiphora, tearing) | 1 | 1 | 1 | 1 | ||||||||||||||
| Ocular surface disease | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||
| Vision-blurred vision | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | ||||||||||
Abbreviations: ANC, absolute neutrophil count; AGC, absolute granulocyte count; PTT, partial thromboplastin time; NOS, not otherwise stated.