Table 2 |.
Frequency of AEs: all grades, grade 3 or higher and treatment-related grade 3 or higher
| Most common AEs with any-grade toxicity | n (%)=36 |
|---|---|
|
| |
| Fatigue | 16 (44.4) |
| Diarrhea | 12 (33.3) |
| Hypothyroidism | 12 (33.3) |
| Constipation | 11 (30.6) |
| Dry mouth | 10 (27.8) |
| Anorexia | 9 (25.0) |
| Headache | 9 (25.0) |
| Hypertension | 9 (25.0) |
| Hyponatremia | 9 (25.0) |
| Oral mucositis | 9 (25.0) |
| Hypomagnesemia | 8 (22.2) |
| Pain | 8 (22.2) |
| Dysphagia | 7 (19.4) |
| Hyperglycemia | 7 (19.4) |
| Palmar-plantar (hand-foot) erythrodysesthesia syndrome | 7 (19.4) |
| Sore throat | 7 (19.4) |
| Abdominal pain | 6 (16.7) |
| Back pain | 6 (16.7) |
| Hypophosphatemia | 6 (16.7) |
| Nausea | 6 (16.7) |
| Oral pain | 6 (16.7) |
| Maculopapular rash | 6 (16.7) |
| Decreased white blood celis | 6 (16.7) |
| Anemia | 5 (13.9) |
| Cough | 5 (13.9) |
| Dysgeusia | 5 (13.9) |
| Respiratory, thoracic and mediastinal disorders—Other, specify | 5 (13.9) |
| Increased alanine aminotransferase | 4 (11.1) |
| Increased AST | 4 (11.1) |
| Dizziness | 4 (11.1) |
| Dyspnea | 4 (11.1) |
| Hypotension | 4 (11.1) |
| Investigations—Other, specify | 4 (11.1) |
| Decreased platelet count | 4 (11.1) |
| Vomiting | 4 (11.1) |
| Dehydration | 3 (8.3) |
| Increased gamma-glutamyl transferase | 3 (8.3) |
| General disorders and administration site conditions— Other, specify | 3 (8.3) |
| Hematuria | 3 (8.3) |
| Hepatobiliary disorders—Other, specify | 3 (8.3) |
| Hypoalbuminemia | 3 (8.3) |
| Hypocalcemia | 3 (8.3) |
| Hypokalemia | 3 (8.3) |
| Increased lipase | 3 (8.3) |
| Pain in extremity | 3 (8.3) |
| Paresthesia | 3 (8.3) |
| Acneiform rash | 3 (8.3) |
| Increased serum amylase | 3 (8.3) |
| Skin and subcutaneous tissue disorders—Other, specify | 3 (8.3) |
| Weight loss | 3 (8.3) |
| Increased alkaline phosphatase | 2 (5.6) |
| Anxiety | 2 (5.6) |
| Arthralgia | 2 (5.6) |
| Aspiration | 2 (5.6) |
| Increased blood bilirubin | 2 (5.6) |
| Dry skin | 2 (5.6) |
| Dyspepsia | 2 (5.6) |
| Ear pain | 2 (5.6) |
| Epistaxis | 2 (5.6) |
| Infections and infestations—Other, specify | 2 (5.6) |
| Leukocytosis | 2 (5.6) |
| Decreased lymphocyte count | 2 (5.6) |
| Oral dysesthesia | 2 (5.6) |
| Pancreatitis | 2 (5.6) |
| Sinusitis | 2 (5.6) |
| Stomach pain | 2 (5.6) |
| All AEs with grade 3 and 4 toxicity | n (%)=36 |
| Overall | 18 (50%) |
| Dysphagia | 3 (8.3) |
| Hypertension | 3 (8.3) |
| Increased AST | 2 (5.6) |
| Back pain | 2 (5.6) |
| Hypotension | 2 (5.6) |
| Oral mucositis | 2 (5.6) |
| Increased alanine aminotransferase | 1 (2.8) |
| Increased alkaline phosphatase | 1 (2.8) |
| Anemia | 1 (2.8) |
| Anorexia | 1 (2.8) |
| Aspiration | 1 (2.8) |
| Increased blood bilirubin | 1 (2.8) |
| Diarrhea | 1 (2.8) |
| Dyspnea | 1 (2.8) |
| Increased gamma-glutamyl transferase | 1 (2.8) |
| Headache | 1 (2.8) |
| Hepatobiliary disorders—Other, specify | 1 (2.8) |
| Hyperglycemia | 1 (2.8) |
| Hyponatremia | 1 (2.8) |
| Hypophosphatemia | 1 (2.8) |
| Hypoxia | 1 (2.8) |
| Increased lipase | 1 (2.8) |
| Myocardial infarction | 1 (2.8) |
| Nausea | 1 (2.8) |
| Gastric obstruction | 1 (2.8) |
| Oral pain | 1 (2.8) |
| Pain | 1 (2.8) |
| Pancreatitis | 1 (2.8) |
| Decreased platelet count | 1 (2.8) |
| Sore throat | 1 (2.8) |
| Vomiting | 1 (2.8) |
| All AEs with grade 3 and 4 toxicity attributed to treatment | n (%)=36 |
| Overall | 6 (17%) |
| Increased AST | 2 (5.6) |
| Increased alanine aminotransferase | 1 (2.8) |
| Increased alkaline phosphatase | 1 (2.8) |
| Increased blood bilirubin | 1 (2.8) |
| Increased gamma-glutamyl transferase | 1 (2.8) |
| Hypertension | 1 (2.8) |
| Hyponatremia | 1 (2.8) |
| Increased lipase | 1 (2.8) |
| Oral mucositis | 1 (2.8) |
Thirty-six patients were accounted for in the AE count. Patients may have more than one AE reported.