Creation of OCCDS-ADCM Dataset - Day:03 of Onco-ADaM Project

Introduction

This is a statistical analysis data structure that describes the general data structure and content typically found in occurrence analysis.

For example like adverse events, concomitant medications, and medical history data structure.

Some required variables for OCCDS are:

• Identifier Variables: STUDYID, USUBJID, — SEQ
• MedDRA Dictionary Coding Variables: — TERM
• Adverse Event Descriptive Variables: AESER(Serious Event)
• WHO Drug Dictionary Coding Variables: CMTRT

ADCM stands for Concomitant Medications Analysis Dataset. The base datasets for this OCCDS is ADaM.ADSL and SDTM.CM.

Variables

I am not including the general variables like USUBJID, SITEID, AGE, SEX, etc., and also not from ADSL. Note that the variables i mention is not limited to this.

1. Concomitant Med Related Variable
   • CMTRT
   • CMDECOD
   • CMCAT
   • CMSCAT
   • CMINDC
   • CMDOSE
   • CMDOSU
   • CMDOSFEQ
   • CMROUTE
   • CMSTDTC
   • CMENDTC
2. Analytical Therapeutical Chemical (ATC) code
   • ATC1C
   • ATC1T
3. Date, Time & Imputation
   • ASTDT
   • ASTDTF
   • AENDT
   • AENDTF
4. Study Day Variable
   • ASTDY
   • AEENDY
5. Flag Variables
   • PRIORFL
   • CONCOMFL
   • FUPFL

Basic Process

First identify the dataset required, usually ADaM.ADSL and SDTM.CM. If there any SUPPCM dataset then transpose it and merge with CM and start creating variables that is just carry forwarded from the raw with just other name and just follow the steps mentioned below.

Finally keep all the required variables and save it to the destination location.

Steps:

1. Identify the SDTM datasets required for programming ADCM.
2. Mark the variables that is carry forwarded from the ADSL dataset.
3. Identify the variables that is as same as in SDTM datasets

From here the programming starts

1. ATC (Analytical Therapeutical Chemical) code variables & WHO-DD version variable usually present in the SUPPCM datasets.
   1. Create a rename the IDVAR value to, which is also, CMSEQ (Also act as a common variable).
   2. Sort by USUBJID & CMSEQ.
   3. Transpose the SUPPCM dataset.
   4. merge them with the CM dataset with common variables.
   5. Assign the ATC level code variables and WHODDVR variable.
2. Merge the CM with the ADSL and create the necessary variables (I call them renaming variables).
3. Date & Time and Imputation variable
   1. Creation of start date with imputation of partial date
   2. Creation of end date with imputation of partial date
4. Creation of Study day variable
   1. Study start day variable
   2. Study end day variable
5. Creation of Medication flag
   1. Prior medication flag
   2. Concomitant medication flag
   3. Follow-up Medication flag
6. Final keeping required variable and saving the file to the destination.

Key-notes

• We create both start & End date imputation in OCCDS.ADCM.
• Flags created in ADCM are, but not limited to: Prior Medication Flag (PRIORFL), Concomitant Medication Flag (CONCOMFL) & Follow-up Medication Flags (FUPFL).

Important

If this the first post you read, then i highly recommend to read my last blogs on this series, link is below down:

1. What is ADaM- Day:01 of Onco-ADaM Project
2. Creation of ADSL- Day: 02 of Onco-ADaM Project

Thank You for Visiting :)