Table 2.
Adverse events and chemotherapy-related toxicity
|
Grade 1–2 |
Grade 3 |
Grade 4 |
Grade 5 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All events (regardless of causality) |
Chemotherapy-related events (ASC plus FOLFOX; n=81) | All events (regardless of causality) |
Chemotherapy-related events (ASC plus FOLFOX; n=81) | All events (regardless of causality) |
Chemotherapy-related events (ASC plus FOLFOX; n=81) | All events (regardless of causality) |
Chemotherapy-related events (ASC plus FOLFOX; n=81) | |||||
| ASC alone (n=81) | ASC plus FOLFOX (n=81) | ASC alone (n=81) | ASC plus FOLFOX (n=81) | ASC alone (n=81) | ASC plus FOLFOX (n=81) | ASC alone (n=81) | ASC plus FOLFOX (n=81) | |||||
| Any* | 35 (43%) | 24 (30%) | 37 (46%) | 35 (43%) | 39 (48%) | 23 (28%) | 3 (4%) | 10 (12%) | 5 (6%) | 4 (5%) | 7 (9%) | 3 (4%) |
| Neuropathy | 8 (10%) | 55 (68%) | 52 (64%) | 0 | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Fatigue or lethargy | 47 (58%) | 58 (72%) | 47 (58%) | 6 (7%) | 15 (19%) | 9 (11%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea | 32 (40%) | 40 (49%) | 30 (37%) | 1 (1%) | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Oral mucositis | 4 (5%) | 29 (36%) | 28 (35%) | 0 | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Anorexia | 31 (38%) | 47 (58%) | 25 (31%) | 6 (7%) | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Diarrhoea | 12 (15%) | 27 (33%) | 22 (27%) | 2 (2%) | 2 (2%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Thrombocytopenia | 1 (1%) | 18 (22%) | 18 (22%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dysgeusia | 11 (14%) | 23 (28%) | 16 (20%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 16 (20%) | 20 (25%) | 14 (17%) | 4 (5%) | 3 (4%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Constipation | 28 (35%) | 35 (43%) | 13 (16%) | 1 (1%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 0 | 13 (16%) | 12 (15%) | 1 (1%) | 8 (10%) | 8 (10%) | 0 | 2 (2%) | 2 (2%) | 0 | 0 | 0 |
| Infection† | 17 (21%) | 19 (23%) | 10 (12%) | 3 (4%) | 12 (15%) | 6 (7%) | 0 | 2 (2%) | 1 (1%) | 2 (2%) | 1 (1%) | 1 (1%) |
| Anaemia | 5 (6%) | 10 (12%) | 9 (11%) | 1 (1%) | 2 (2%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Dry mouth | 11 (14%) | 20 (25%) | 9 (11%) | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pain | 50 (62%) | 42 (52%) | 6 (7%) | 5 (6%) | 8 (10%) | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 |
| Tinnitus | 2 (2%) | 8 (10%) | 5 (6%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia | 5 (6%) | 10 (12%) | 4 (5%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Oedema | 9 (11%) | 17 (21%) | 4 (5%) | 1 (1%) | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Dyspnoea | 6 (7%) | 13 (16%) | 3 (4%) | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Muscle weakness | 9 (11%) | 6 (7%) | 3 (4%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Thromboembolic event | 2 (2%) | 3 (4%) | 3 (4%) | 4 (5%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cough | 4 (5%) | 11 (14%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dyspepsia | 10 (12%) | 8 (10%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Weight loss | 9 (11%) | 8 (10%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Abdominal distension | 7 (9%) | 3 (4%) | 1 (1%) | 0 | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Biliary event‡ | 2 (2%) | 2 (2%) | 1 (1%) | 13 (16%) | 13 (16%) | 2 (2%) | 2 (2%) | 2 (2%) | 0 | 2 (2%) | 1 (1%) | 0 |
| Catheter-related infection | 0 | 2 (2%) | 1 (1%) | 0 | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema | 1 (1%) | 2 (2%) | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypertension | 4 (5%) | 10 (12%) | 1 (1%) | 1 (1%) | 4 (5%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypophosphatemia | 0 | 2 (2%) | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Hypotension | 1 (1%) | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Acute kidney injury | 2 (2%) | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 2 (2%) | 1 (1%) |
| Allergic reaction | 0 | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Ascites | 2 (2%) | 10 (12%) | 0 | 2 (2%) | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cerebrovascular ischaemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Dehydration | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Diabetic ketoacidosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
| Fall | 0 | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 1 (1%) |
| Fracture (non-pathological) | 0 | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gastric outlet obstruction | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal bleeding | 3 (4%) | 1 (1%) | 0 | 2 (2%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Generalised muscle weakness | 1 (1%) | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hallucinations | 1 (1%) | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hip fracture | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypercalcemia | 1 (1%) | 1 (1%) | 0 | 1 (1%) | 1 (1%) | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 |
| Hyperglycaemia | 2 (2%) | 2 (2%) | 0 | 0 | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypoalbuminemia | 1 (1%) | 2 (2%) | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypokalaemia | 0 | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Hyponatremia | 2 (2%) | 2 (2%) | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypoxia | 0 | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Insomnia | 6 (7%) | 4 (5%) | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Leg oedema | 3 (4%) | 3 (4%) | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Liver failure | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myocardial infarction | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 0 | 0 | 0 |
| Pleural effusion | 0 | 0 | 0 | 0 | 2 (2%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rhabdomyolisis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
Adverse events are listed in order of frequency, with the most frequent chemotherapy-related pooled grade 1/2 adverse events listed first. All grade 1–2 adverse events occurring in at least 10% of patients and all grade 3, 4, and 5 events are reported. Full details are available in the appendix (p 10). All percentages are calculated by intention to treat. ASC=active symptom control. FOLFOX=folinic acid, fluorouracil, and oxaliplatin.
*
Refers to highest grade overall within-subject adverse events.
†
Lung, urinary, fever, or not specified, excluding liver or biliary.
‡
Includes liver infection, increased bilirubin or alkaline phosphatase, and hepatitis.