Table 5 Number of adverse events (AEs) and Grade 3 or 4 AEs reported during the study and assignment of causality to the treatment received. The number of Grade 3 and 4 AEs is shown in parenthesis
Everolimus | Lanreotide and everolimus | Sunitinib | Lanreotide and sunitinib | Lanreotide | |
|---|---|---|---|---|---|
All AEs (Grade 3–4) | All AEs (Grade 3–4) | All AEs (Grade 3–4) | All AEs (Grade 3–4) | All AEs (Grade 3–4) | |
AE | 129 (21) | 9 (2) | 70 (17) | 15 (5) | 6 (1) |
Asthenia | 15 (5) | 0 | 22 (8) | 2 (0) | 0 |
Mucositis | 25 (6) | 0 | 6 (0) | 0 | 0 |
Diarrhoea | 17 (2) | 1 (0) | 5 (1) | 5 (1) | 1 (0) |
Hand-foot skin reaction | 8 (0) | 0 | 8 (1) | 0 | 0 |
Anorexia | 9 (1) | 0 | 4 (1) | 0 | 0 |
Hyperglycaemia | 7 (0) | 4 (1) | 0 | 1 (0) | 1 (0) |
Rash | 10 (2) | 1 (1) | 0 | 0 | 0 |
Hypertension | 2 (0) | 0 | 6 (1) | 0 | 0 |
Peripheral oedema | 6 (2) | 0 | 1 (0) | 0 | 0 |
Thrombocytopenia | 0 | 0 | 4 (0) | 3 (3) | 0 |
Anaemia | 5 (0) | 0 | 0 | 2 (1) | 0 |
Pneumonitis | 3 (1) | 0 | 1 (0) | 0 | 0 |
Cardiac toxicity | 0 | 0 | 3 (2) | 0 | 0 |
Hypercholesterolemia | 4 (0) | 0 | 0 | 0 | 0 |
Hypertriglyceridemia | 4 (0) | 0 | 0 | 0 | 0 |
Leucopoenia | 1 (0) | 0 | 2 (1) | 1 (0) | 0 |
Hepatic alterations | 0 | 2 (0) | 0 | 0 | 0 |
Hypothyroidism | 0 | 0 | 3 (0) | 0 | 0 |
Nausea | 1 (0) | 0 | 0 | 0 | 0 |
Vomiting | 1 (0) | 0 | 1 (0) | 0 | 0 |
Abdominal pain | 1 (0) | 0 | 0 | 0 | 2 (0) |
Weight loss | 1 (0) | 0 | 0 | 1 (0) | 0 |
Headache | 0 | 0 | 0 | 0 | 0 |
Epistaxis | 0 | 0 | 1 (0) | 0 | 0 |
Other | 9 (2) | 1 (0) | 3 (2) | 0 | 2 (1) |