Table 2 Safety and adverse events (safety population)
12 Weeks24 Weeks
Everolimus + MethotrexatePlacebo + MethotrexateEverolimus + MethotrexatePlacebo + Methotrexate
(n = 61)(n = 60)(n = 61)(n = 60)
Serious adverse events:
    Death0010
    Non-fatal serious adverse event4241
    Serious infections2000
Treatment discontinuation due to adverse events106NANA
Drug-related adverse events381410
    Gastrointestinal disorders19600
    Skin/subcutaneous disorders10100
    Infections/infestations6100
Any adverse event54421721
Adverse events differing in incidence by >5% between groups:
    Gastrointestinal disorders321932
        Aphtous stomatitis4000
        Diarrhoea6201
        Mouth ulceration5000
Infections/infestations201124
    Gastroenteritis4010
Metabolism and nutrition disorders6202
    Hypercholesterolemia4101
Musculoskeletal/connective tissue disorders48310
Nervous system disorders13650
    Headache10510
Renal and urinary disorders4000
Respiratory, thoracic and mediastinal disorders11230
    Pharyngolaryngeal pain4110
Skin and subcutaneous tissue disorders18514