Hazard Ratios for Key Events by Study Phase.
Table gives number of patients experiencing an event during the indicated study period and rate per 100 patient months follow-up. HR = hazard ratio (IL-2 versus control) from a proportional hazards model stratified by region. Main study refers to the period from randomization to 28 February 2009, the original planned end of the study (patients at risk: 176 IL-2, 91 control). Extension refers to the extended follow-up phase, from 1 March 2009 through 28 February 2011 (patients at risk: 142 IL-2, 80 control). Interaction p-values shown are for treatment group by study phase interaction.*
This reflects one additional OD event, in the control group, that was reported after the analysis and publication of the original study data.