Most common adverse events (reported in ≥10% of patients), serious adverse events, and events leading to medication withdrawal over 62 weeks, grouped by system organ class
| Everolimus | |
| Patients n | 24 |
| Patients with ≥1 adverse event | 24 (100) |
| Most common adverse events (≥10%) | |
| Gastrointestinal disorders | 22 (92) |
| Stomatitis# | 18 (75) |
| Diarrhoea | 7 (29) |
| Nausea | 7 (29) |
| Vomiting | 4 (17) |
| Haemorrhoids | 3 (13) |
| Respiratory, thoracic or mediastinal disorders | 18 (75) |
| Cough | 7 (29) |
| Oropharyngeal pain | 7 (29) |
| Nasal congestion | 4 (17) |
| Dyspnoea | 3 (13) |
| General disorders | 17 (71) |
| Peripheral oedema | 8 (33) |
| Fatigue | 7 (29) |
| Noncardiac chest pain | 6 (25) |
| Pyrexia | 3 (13) |
| Skin and subcutaneous tissue disorders | 17 (71) |
| Acne | 5 (21) |
| Pruritus | 3 (13) |
| Rash | 3 (13) |
| Infections and infestations | 15 (63) |
| Nasopharyngitis | 4 (17) |
| Upper respiratory tract infection | 3 (13) |
| Nervous system disorders | 12 (50) |
| Headache | 9 (38) |
| Musculoskeletal and connective tissue disorders | 10 (42) |
| Arthralgia | 4 (17) |
| Muscle spasms | 3 (13) |
| Metabolism and nutrition disorders | 7 (29) |
| Decreased appetite | 3 (13) |
| Psychiatric disorders | 4 (17) |
| Insomnia | 3 (13) |
| Serious adverse events | |
| General disorders | 4 (17) |
| Peripheral oedema | 2 (8) |
| Noncardiac chest pain | 1 (4) |
| Pyrexia | 1 (4) |
| Infections and infestations | 3 (13) |
| Bronchitis | 1 (4) |
| Pneumocystis jirovecii infection | 1 (4) |
| Pneumonia | 1 (4) |
| Cardiac disorders | 2 (8) |
| Cardiac failure | 1 (4) |
| Pericarditis | 1 (4) |
| Tachycardia | 1 (4) |
| Renal and urinary disorders | 1 (4) |
| Nephrolithiasis | 1 (4) |
| Respiratory, thoracic and mediastinal disorders | 1 (4) |
| Dyspnoea | 1 (4) |
| Adverse events leading to study discontinuation | |
| Investigations | |
| γ-Glutamyl transpeptidase increased | 1 (4) |
| Low phosphorus | 1 (4) |
| Oxygen consumption increased | 1 (4) |
| General disorders | |
| Noncardiac chest pain | 1 (4) |
| Peripheral oedema | 1 (4) |
| Reproductive system disorders | |
| Menometrorrhagia | 1 (4) |
| Respiratory, thoracic, and mediastinal disorders | |
| Lung disorder | 1 (4) |
Data are presented as n (%). #: combines reports of aphthous stomatitis, stomatitis, and mouth ulcerations.