Outcome | |||||
Hospitalised infection | Tuberculosis | Hospitalised Herpes zoster | All Herpes zoster | ||
Incidence rate of hospitalised infection per 100 PY (95% CI)*† | Fostamatinib trials | 2.92* (2.44 to 3.46)† | NC | NC | 1.14 (0.85 to 1.49) |
CORRONA | 1.30 (1.18 to 1.42) | 0.04 (0.03 to 0.06) | 0.02 (0.01 to 0.04) | 0.66 (0.59 to 0.73) | |
SRR | 1.62 (1.52 to 1.72) | 0.02 (0.01 to 0.03) | 0.01 (0.01 to 0.02) | NA | |
NOAR | 1.56 (1.30 to 1.88) | NC | NC | NA | |
CORRONA International | 1.50 (1.09 to 2.05) | 0.35 (0.17 to 0.67) | NC | 0.26 (0.11 to 0.54) | |
IORRA | 1.14 (1.05 to 1.25) | 0.17 (0.13 to 0.22) | 0.15 (0.12 to 0.19) | 1.94 (1.82 to 2.07) |
*Rate: incidence rates per 100 PY. Incidence rates for the registry data were standardised according to the age and sex distribution in the RA clinical trial programme overall analysis; for the RA clinical trial programme crude incidence is presented
†95% CI: approximate CIs based on the gamma distribution for registry data and exact Poisson CIs for the RA clinical trial programme.
CORRONA, Consortium of Rheumatology Researchers of North America; IORRA, Institute of Rheumatology Rheumatoid Arthritis; NA, not available; NC, not calculated due to too few events (rates were only produced if at least five events were observed); NOAR, Norfolk Arthritis Register; PY, person-years; SRR, Swedish Rheumatology Quality of Care Register.