VARIABLE_NAME	VARIABLE_LABEL	TYPE	GENERAL_COMMENT
STUDYID	Study Identifier	_	EC.STUDYID
USUBJID	Unique Subject Identifier	_	EC.USUBJID
PARAM	Parameter	_	Populate as "Treatment Duration in days" when PARAMCD="TRTDURD". Populate as "Nr of Actual Study Drug Administrations" when PARAMCD="NADMIN". Populate as "Total Planned Dose (mg)" when PARAMCD="TOTPLDOS". Populate as "Total Actual Dose (mg)" when PARAMCD="TOTACDOS". Populate as "Number of missed doses" when PARAMCD="NMISSDOS". Populate as "Relative Dose Intensity (%)" when PARAMCD="RDOSINT"
PARAMCD	Parameter Code	_	Create the following parameters using SDTM.EC data . 1) TRTDURD 2) NADMIN 3) TOTPLDOS 4) TOTACDOS 5) NMISSDOS 6) RDOSINT
PARAMN	Parameter (N)	_	Populate as 1 when PARAMCD="TRTDURD". Populate as 2 when PARAMCD="NADMIN". Populate as 3 when PARAMCD="TOTPLDOS". Populate as 4 when PARAMCD="TOTACDOS". Populate as 5 when PARAMCD="NMISSDOS". Populate as 6 when PARAMCD="RDOSINT"
AVAL	Analysis Value	_	Populate using below rules: 1) TRTDURD: Step 1: Get the earliest and latest dates across ECSTDTC and ECENDTC for each subject into two separate variables from the records where ECOCCUR="Y". Step 2: Calcualte the duration as latest date - earliest date+1. 2) NADMIN: Step 1: Get the duration on each record where ECOCCUR="Y" as ECENDTC-ECSTDTC+1. Step 2: Calculate the sum of durations on individual records from step 1 per each subject. 3) TOTPLDOS: Create record for each subject in SDTM.EC and assign a value of 1500. 4) TOTACDOS: Populate using the result from NADMIN parameter, as NADMIN*100. 5) NMISSDOS: Step 1: Get the duration on each record where ECOCCUR="N" as ECENDTC-ECSTDTC+1. Step 2: Calculate the sum of durations on individual records from step 1 per each subject. Populate as 0 when there exists no record for a subject with ECOCCUR="N". 6) RDOSINT: Populate using the result from TOTACDOS and TOTPLDOS, as TOTACDOS/TOTPLDOS*100. Round the result to two decimal places.

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