n/NAR | IR | |
---|---|---|
Treatment emergent AE | 3391/3770 | 25.8 |
Serious AE (including death) | 940/3770 | 7.2 |
Temporary d/c due to AE | 1241/3647 | 9.5 |
Permanent d/c due to AE | 644/3770 | 4.8 |
Death | 69/3770 | 0.52 |
Serious infection | 344/3770 | 2.7 |
Opportunistic infection (excluding tuberculosis, including multidermatomal herpes zoster) | 59/3770 | 0.44 |
Herpes zoster | 384/3770 | 3.0 |
Tuberculosis | 20/3770 | 0.15 |
Major adverse cardiovascular events* | 63/3251 | 0.50 |
DVT | 41/3770 | 0.31 |
PE | 32/3770 | 0.24 |
DVT and/or PE | 60/3770 | 0.45 |
Malignancies excluding NMSC | 120/3770 | 0.90 |
NMSC | 44/3770 | 0.33 |
Lymphoma | 8/3770 | 0.06 |
Gastrointestinal perforation | 6/3770 | 0.04 |
*studies with positive adjudication. AE=adverse event; D/C= discontinuation; DVT=deep vein thrombosis; IR=incidence rate; NAR=number of patients at risk; NMSC=non-melanoma skin cancer; PE=pulmonary embolism