myCSG © |Area: ADaM| Concept: ADCM : Full ADCM - Concomitant Medication Analysis Dataset | Lesson: L1101 : ADCM dataset for a parallel arm study - statschoice-001 |

Concomitant Medications
  • Concomitant medications refer to any other prescription drugs, over-the-counter medications, or supplements that participants are using during the trial.
  • In clinical trials, concomitant medication information is collected to understand the effects and interactions of other medications that participants may be taking alongside the investigational drug being studied.
  • By collecting this information, researchers can evaluate how these concomitant medications may influence the safety and effectiveness of the study drug.
  • This helps to ensure that any observed effects are attributable to the investigational drug and not influenced by other medications.
  • Additionally, studying concomitant medications can provide valuable insights into potential drug interactions, side effects, and overall treatment strategies.
  • Ultimately, collecting information about concomitant medications helps to paint a comprehensive picture of how the investigational drug behaves in real-world scenarios, improving the overall understanding of its benefits and risks.

ATC classification of drugs
  • The Anatomical Therapeutic Chemical (ATC) classification system is a widely used system for categorizing drugs based on their therapeutic properties and anatomical target.
  • It was developed by the World Health Organization (WHO) in collaboration with various drug regulatory agencies.
  • The ATC system provides a standardized and internationally recognized framework that allows for the systematic classification and comparison of drugs.
  • It assigns a unique code to each drug, organizing them into different levels of classification, including
    • anatomical main groups,
    • therapeutic subgroups, and
    • pharmacological subgroups.
  • This classification system helps healthcare professionals, researchers, and regulatory agencies in identifying, tracking, and analyzing drugs based on their intended use and therapeutic effects.

Examples of ATC classification

  1. Paracetamol (acetaminophen):

    • ATC code: N02BE01
    • Anatomical main group: Nervous system
    • Therapeutic subgroup: Analgesics
    • Pharmacological subgroup: Anilides

  2. Omeprazole:

    • ATC code: A02BC01
    • Anatomical main group: Alimentary tract and metabolism
    • Therapeutic subgroup: Drugs for acid-related disorders
    • Pharmacological subgroup: Proton pump inhibitors

  3. Metformin:

    • ATC code: A10BA02
    • Anatomical main group: Alimentary tract and metabolism
    • Therapeutic subgroup: Drugs used in diabetes
    • Pharmacological subgroup: Biguanides

  4. Insulin:

    • ATC code: A10AB
    • Anatomical main group: Alimentary tract and metabolism
    • Therapeutic subgroup: Drugs used in diabetes
    • Pharmacological subgroup: Insulins and analogues

These examples demonstrate how the ATC system assigns specific codes to drugs based on their therapeutic properties, anatomical target, and pharmacological classification. The ATC codes provide a standardized way of identifying and categorizing drugs, allowing for easy comparison and analysis across different medications.

Concomitant Medications Analysis Dataset complete programming covering:
Start date imputation
End date imputation
Date imputation flags
On treatment medications flag
Prior Medications flag
Study day creation etc.

VARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENT
STUDYID Study Identifier _ CM.STUDYID
USUBJID Unique Subject Identifier _ CM.USUBJID
CMSEQ Sequence Number _ CM.CMSEQ
CMTRT Reported Name of Drug, Med or Therapy _ CM.CMTRT
CMMODIFY Modified Reported Name _ CM.CMMODIFY
CMDECOD Standardized Medication Name _ CM.CMDECOD
ATC1CD ATC Level 1 Code _ CM.ATC1CD
ATC2CD ATC Level 2 Code _ CM.ATC2CD
ATC3CD ATC Level 3 Code _ CM.ATC3CD
ATC1 ATC Level 1 Text _ CM.ATC1
ATC2 ATC Level 2 Text _ CM.ATC2
ATC3 ATC Level 3 Text _ CM.ATC3
CMINDC Indication _ CM.CMINDC
CMDOSFRM Dose Form _ CM.CMDOSFRM
CMDOSE Dose per Administration _ CM.CMDOSE
CMDOSU Dose Units _ CM.CMDOSU
CMDOSFRQ Dosing Frequency Per Interval _ CM.CMDOSFRQ
CMROUTE Route of Administration _ CM.CMROUTE
CMSTDTC Start Date/Time of Medication _ CM.CMSTDTC
ASTDT Analysis Start Date _ Populate using CM.CMSTDTC.
When CMSTDTC is full, convert it to numeric format.
When only day component is missing use first day of the month
When month component is missing use "January"
When full date is missing, use treatment start date (ADSL.TRTSDT)
ASTDTF Analysis Start Date Imputation Flag _ If start date is completely missing or missing the year then ASTDTF="Y" Else if start date has month missing then ASTDTF="M" Else if start date has day missing then ASTDTF="D"
ASTDY Analysis Start Relative Day _ If ASTDT>=TRTSDT, populate as ASTDT-TRTSDT+1. Else if ASTDT < TRTSDT, populate as ASTDT-TRTSDT.
CMENDTC End Date/Time of Medication _ CM.CMENDTC
AENDT Analysis End Date _ Populate using CM.CMENDTC.
When CMENDTC is full, convert it to numeric format.
When only day component is missing use last day of the month
When month component is missing and if the year is same as treatment end date, then use the treatment end date (ADSL.TRTEDT). Else if it is a different year, use 31st December of that year.
When full date is missing, use treatment end date (ADSL.TRTEDT).
AENDTF Analysis End Date Imputation Flag _ If end date is completely missing or missing the year then AENDTF="Y" Else if end date has month missing then AENDTF="M" Else if end date has day missing then AENDTF="D"
CMENRF End Relative to Reference Period _ CM.CMENRF
AENDY Analysis End Relative Day _ If AENDT>=TRTSDT, populate as AENDT-TRTSDT+1. Else if AENDT < TRTSDT, populate as AENDT-TRTSDT.
ONTRTFL On-Treatment Flag _ Populate as "Y" if subject took at least one dose of medication in between treatment start (ADSL.TRTSDT) and treament end (ADSL.TRTEDT).
PREFL Pre-treatment Flag _ Populate as "Y" if the medication started and stopped before treatment start (ADSL.TRTSDT).
SAFFL Safety Population Flag _ ADSL.SAFFL
TRTA Actual Treatment _ ADSL.TRT01A
TRTAN Actual Treatment (N) _ ADSL.TRT01AN Drug A = 1 Drug B = 2
TRTSDT Date of First Exposure to Treatment _ ADSL.TRTSDT
TRTEDT Date of Last Exposure to Treatment _ ADSL.TRTEDT
AGE Age _ ADSL.AGE
AGEGR1 Pooled Age Group 1 _ ADSL. AGEGR1
SEX Sex _ ADSL.SEX
RACE Race _ ADSL.RACE
Complete SAS code to generate the output is available for registered users!

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