End Date Variable to Use for Censoring

Note: This option is used, with modifications for Mortality Time to Event , Progression Free Survival, and . Drug-induced Liver Injury. Refer to the report specific descriptions below.

For Mortality Time to Event

Select which variable date reference from the demography domain to use for calculation of censored death values.

Available options are listed in the following table:

Option:	Select when you want to:
Subject Reference End Data	• Use the reference end date (RFENDTC) as the end date. This option is selected by default.
Date of Last Study Treatment	• Use the date of the last study treatment (RFXENDTC) as the end date.
Date of End of Participation	• Use the date on which the subject left the study (RFPENDTC) as the end date.
Last Disposition Record Date	• Use the last disposition record date as the cutoff date for each of the subjects.

For Progression Free Survival

Select which variable date reference to use for calculation of censored subject duration values.

Available options are listed in the following table:

Option:	Select when you want to:
Subject Reference End Data	• Use the reference end date (RFENDTC) as the end date.
Date of Last Study Treatment	• Use the date of the last study treatment (RFXENDTC) as the end date.
Date of End of Participation	• Use the date on which the subject left the study (RFPENDTC) as the end date.
Last Response Assessment Date	• Use the last date on which the subject showed a response to the treatment (RSDTC or RSDY) as the end date.This option is selected by default.

Note: Date information is typically taken from RS. If, however, there is no date information in RS, these reports merge RS and SV by USUBJID and VISIT/VISITNUM and the SV dates are used.

For Drug Induced Liver Injury

Select which variable date reference to use for censored subject duration values.

Available options are listed in the following table:

Option:	Select when you want to:
Last Disposition Record Date	• Use the last disposition record date as the cutoff date for each of the subjects.
Subject Reference End Data	• Use the reference end date (RFENDTC) as the end date. This option is selected by default.

For All Reports

To Specify an End Date Variable:

8

Make a selection using the drop-down menu.