•Summary Data: Data tables provided by sponsors that include only numbers of patients with events as numerators and either total patients exposed or total accumulated person-time as denominators
•Patient Level Data: Data sets provided by sponsors in response to detailed requests made by FDA for electronic data sets structured to include one row per patient participating in each study, with multiple
variables for each patient.
–Patient level data sets permit adjustments for potentially important covariates, while summary data do not.
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