Table 3.
Adverse events during AFHX (n = 28).
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | |
| Blood and lymphatic system | ||||||||||
| Anaemia | 10 | 36% | 7 | 25% | 7 | 25% | 0 | 0% | 0 | 0% |
| Blood and lymphatic system disorders (other) | 6 | 21% | 3 | 11% | 3 | 11% | 0 | 0% | 0 | 0% |
| Febrile neutropenia | 0 | 0% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Leukocytosis | 0 | 0% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Neutrophil count decreased | 1 | 4% | 1 | 4% | 2 | 7% | 0 | 0% | 0 | 0% |
| Platelet count decreased | 3 | 11% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| CD4 lymphocytes decreased | 5 | 18% | 4 | 14% | 1 | 4% | 0 | 0% | 0 | 0% |
| White blood cell decreased | 4 | 14% | 3 | 11% | 1 | 4% | 1 | 4% | 0 | 0% |
| Cardiac | ||||||||||
| Atrial fibrillation | 1 | 4% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Chest pain—cardiac | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Sinus tachycardia | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Ear and labyrinth | ||||||||||
| Ear and labyrinth disorders (other) | 3 | 11% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Ear pain | 4 | 14% | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% |
| Hearing impaired | 2 | 7% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Tinnitus | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Endocrine | ||||||||||
| Hypothyroidism | 5 | 18% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Eye | ||||||||||
| Blurred vision | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Eye disorders (other) | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Watering eyes | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Gastrointestinal | ||||||||||
| Abdominal pain | 3 | 11% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Constipation | 22 | 79% | 1 | 4% | 1 | 4% | 0 | 0% | 0 | 0% |
| Diarrhoea | 10 | 36% | 3 | 11% | 0 | 0% | 0 | 0% | 0 | 0% |
| Dry mouth | 13 | 46% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Dysphagia | 20 | 71% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Gastroesophageal reflux disease | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Gastrointestinal disorders (other) | 5 | 18% | 3 | 11% | 1 | 4% | 0 | 0% | 0 | 0% |
| Haemorrhoids | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Mucositis oral | 18 | 64% | 18 | 64% | 9 | 32% | 4 | 14% | 0 | 0% |
| Nausea | 27 | 96% | 3 | 11% | 1 | 4% | 0 | 0% | 0 | 0% |
| Oral dysesthesia | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Oral pain | 10 | 36% | 5 | 18% | 1 | 4% | 0 | 0% | 0 | 0% |
| Salivary duct inflammation | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Upper gastrointestinal haemorrhage | 0 | 0% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Vomiting | 9 | 32% | 1 | 4% | 1 | 4% | 0 | 0% | 0 | 0% |
| General | ||||||||||
| Chills | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Oedema face | 4 | 14% | 1 | 4% | 2 | 7% | 0 | 0% | 0 | 0% |
| Oedema limbs | 6 | 21% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Facial pain | 4 | 14% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Fatigue | 26 | 93% | 4 | 14% | 0 | 0% | 0 | 0% | 0 | 0% |
| Fever | 5 | 18% | 1 | 4% | 1 | 4% | 0 | 0% | 0 | 0% |
| Localised oedema | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Neck oedema | 4 | 14% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Pain | 8 | 29% | 1 | 4% | 1 | 4% | 0 | 0% | 0 | 0% |
| Infections and infestations | ||||||||||
| Infections and infestations (other) | 1 | 4% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Laryngitis | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Pelvic infection | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Skin infection | 1 | 4% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Wound infection | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Injury, poising and procedural complications | ||||||||||
| Dermatitis radiation | 9 | 32% | 14 | 50% | 6 | 21% | 0 | 0% | 0 | 0% |
| Fall | 1 | 4% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Fracture | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Hepatic | ||||||||||
| Alanine aminotransferase increased | 3 | 11% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Aspartate aminotransferase increased | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Metabolism and nutrition | ||||||||||
| Weight loss | 4 | 14% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Alkalosis | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Anorexia | 20 | 71% | 2 | 7% | 1 | 4% | 0 | 0% | 0 | 0% |
| Dehydration | 4 | 14% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Hypercalcemia | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Hyperglycaemia | 7 | 25% | 3 | 11% | 1 | 4% | 0 | 0% | 0 | 0% |
| Hyperkalemia | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Hypoalbuminemia | 3 | 11% | 3 | 11% | 0 | 0% | 0 | 0% | 0 | 0% |
| Hypocalcemia | 1 | 4% | 2 | 7% | 1 | 4% | 0 | 0% | 0 | 0% |
| Hypokalemia | 2 | 7% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Hypomagnesemia | 3 | 11% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Hyponatremia | 2 | 7% | 0 | 0% | 2 | 7% | 0 | 0% | 0 | 0% |
| Hypophosphatemia | 1 | 4% | 6 | 21% | 1 | 4% | 0 | 0% | 0 | 0% |
| Metabolism and nutrition disorders (other) | 0 | 0% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Musculoskeletal | ||||||||||
| Back pain | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Muscle weakness upper limb | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Musculoskeletal and connective tissue disorder (other) | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Neck pain | 6 | 21% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Pain in extremity | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Trismus | 5 | 18% | 2 | 7% | 1 | 4% | 0 | 0% | 0 | 0% |
| Nervous system | ||||||||||
| Dizziness | 4 | 14% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Dysarthria | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Dysgeusia | 5 | 18% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Headache | 4 | 14% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Paraesthesia | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Peripheral sensory neuropathy | 5 | 18% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Tremor | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Psychiatric | ||||||||||
| Anxiety | 5 | 18% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Confusion | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Depression | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Insomnia | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Renal and urinary | ||||||||||
| Creatinine increased | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Renal and urinary disorders (other) | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Urine discolouration | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Respiratory | ||||||||||
| Aspiration | 2 | 7% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Cough | 7 | 25% | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% |
| Dyspnoea | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Nasal congestion | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Productive cough | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Pulmonary hypertension | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Respiratory, thoracic and mediastinal disorders (other) | 4 | 14% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Sleep apnoea | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Sore throat | 3 | 11% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Wheezing | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Skin and subcutaneous tissue | ||||||||||
| Alopecia | 6 | 21% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Erythema multiforme | 3 | 11% | 2 | 7% | 2 | 7% | 0 | 0% | 0 | 0% |
| Hyperhidrosis | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Palmar–plantar erythrodysesthesia syndrome | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Pruritus | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Rash acneiform | 1 | 4% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Rash maculopapular | 2 | 7% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Scalp pain | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
| Skin and subcutaneous tissue disorders (other) | 5 | 18% | 1 | 4% | 1 | 4% | 0 | 0% | 0 | 0% |
| Skin ulceration | 1 | 4% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |
| Vascular | ||||||||||
| Hypotension | 2 | 7% | 0 | 0% | 1 | 4% | 0 | 0% | 0 | 0% |
| Thromboembolic event | 2 | 7% | 1 | 4% | 0 | 0% | 0 | 0% | 0 | 0% |