Table 3:
Summary of adverse events by NCI Common Toxicity Criteria version 4.0 and treatment
| Sunitinib (n=51) | Everolimus (n=57) | ||||||
|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | ||
| Nausea | 33 (65%) | 3 (6%) | 0 | 25 (44%) | 1 (2%) | 0 | |
| Decreased appetite | 29 (57%) | 1 (2%) | 0 | 15 (26%) | 0 | 0 | |
| Diarrhoea | 29 (57%) | 5 (10%) | 0 | 16 (28%) | 1 (2%) | 0 | |
| Fatigue | 29 (57%) | 2 (4%) | 0 | 29 (51%) | 4 (7%) | 0 | |
| Dysgeusia | 25 (49%) | 0 | 0 | 18 (32%) | 0 | 0 | |
| Infection | 25 (49%) | 6 (12%) | 0 | 24 (42%) | 4 (7%) | 0 | |
| Hand-foot syndrome | 17 (33%) | 2 (4%) | 2 (4%) | 8 (14%) | 0 | 0 | |
| Constipation | 15 (29%) | 0 | 0 | 10 (18%) | 0 | 0 | |
| Stomatitis | 14 (27%) | 0 | 0 | 22 (39%) | 5 (9%) | 0 | |
| Vomiting | 14 (27%) | 3 (6%) | 0 | 13 (23%) | 0 | 0 | |
| Anaemia | 13 (25%) | 1 (2%) | 0 | 10 (18%) | 6 (11%) | 0 | |
| Back pain | 12 (24%) | 2 (4%) | 0 | 6 (11%) | 0 | 0 | |
| Mucosal inflammation | 12 (24%) | 0 | 0 | 13 (23%) | 1 (2%) | 0 | |
| Arthralgia | 11 (22%) | 1 (2%) | 0 | 7 (12%) | 0 | 0 | |
| Dyspepsia | 11 (22%) | 0 | 0 | 0 | 0 | 0 | |
| Hypertension | 11 (22%) | 11 (22%) | 1 (2%) | 0 | 1 (2%) | 0 | |
| Aspartate aminotransferase concentration increased | 10 (20%) | 0 | 0 | 6 (11%) | 1 (2%) | 0 | |
| Rash | 10 (20%) | 1 (2%) | 0 | 17 (30%) | 1 (2%) | 0 | |
| Blood creatinine concentration increased | 9 (18%) | 0 | 0 | 6 (11%) | 0 | 0 | |
| Anxiety | 8 (16%) | 0 | 0 | 0 | 0 | 0 | |
| Cough | 8 (16%) | 0 | 0 | 24 (42%) | 1 (2%) | 0 | |
| Dyspnoea | 8 (16%) | 1 (2%) | 0 | 20 (35%) | 1 (2%) | 1 (2%) | |
| Lethargy | 8 (16%) | 2 (4%) | 0 | 8 (14%) | 1 (2%) | 0 | |
| Thrombocytopenia | 8 (16%) | 4 (8%) | 0 | 6 (11%) | 1 (2%) | 0 | |
| Abdominal pain | 7 (14%) | 1 (2%) | 0 | 8 (14%) | 1 (2%) | 0 | |
| Dry skin | 7 (14%) | 0 | 0 | 11 (19%) | 0 | 0 | |
| Gastro-oesophageal reflux disease | 7 (14%) | 0 | 0 | 0 | 0 | 0 | |
| Peripheral oedema | 7 (14%) | 1 (2%) | 0 | 14 (25%) | 1 (2%) | 0 | |
| Pruritus | 7 (14%) | 0 | 0 | 7 (12%) | 1 (2%) | 0 | |
| Weight loss | 7 (14%) | 0 | 0 | 10 (18%) | 0 | 0 | |
| White blood cell count decreased | 7 (14%) | 1 (2%) | 0 | 0 | 0 | 0 | |
| Dizziness | 6 (12%) | 0 | 0 | 0 | 0 | 0 | |
| Epistaxis | 6 (12%) | 2 (4%) | 0 | 11 (19%) | 0 | 0 | |
| Flatulence | 6 (12%) | 0 | 0 | 0 | 0 | 0 | |
| Pain in extremity | 6 (12%) | 1 (2%) | 0 | 0 | 1 (2%) | 0 | |
| Platelet count decreased | 6 (12%) | 2 (4%) | 0 | 0 | 0 | 0 | |
| Alanine aminotransferase concentration increased | 5 (10%) | 0 | 0 | 0 | 0 | 0 | |
| Dry mouth | 5 (10%) | 0 | 0 | 0 | 0 | 0 | |
| Headache | 5 (10%) | 0 | 0 | 0 | 2 (4%) | 0 | |
| Hypomagnesaemia | 5 (10%) | 0 | 0 | 0 | 0 | 0 | |
| Neutrophil count decreased | 5 (10%) | 3 (6%) | 0 | 0 | 0 | 0 | |
| Pain | 5 (10%) | 0 | 0 | 0 | 1 (2%) | 0 | |
| Hyperglycaemia | 4 (8%) | 0 | 0 | 7 (12%) | 0 | 0 | |
| Pyrexia | 4 (8%) | 0 | 0 | 8 (14%) | 0 | 0 | |
| Insomnia | 3 (6%) | 0 | 0 | 6 (11%) | 0 | 0 | |
| Musculoskeletal chest pain | 2 (4%) | 0 | 0 | 6 (11%) | 0 | 0 | |
| Maculo-papular rash | 2 (4%) | 0 | 0 | 6 (11%) | 0 | 0 | |
| Blood cholesterol concentration increased | 1 (2%) | 0 | 0 | 7 (12%) | 0 | 0 | |
| Hypertriglyceridaemia | 0 | 0 | 0 | 5 (9%) | 3 (5%) | 0 | |
| Pneumonitis | 0 | 0 | 0 | 3 (5%) | 4 (7%) | 1 (2%) | |
Adverse events with a frequency of 10% or more in eithertreatment group are presented. Patients are counted only once by the worst grade adverse event experienced. No treatment-related deaths were reported.