myCSG © |Area: ADaM| Concept: ADCM : Full ADCM - Concomitant Medication Analysis Dataset | Lesson: LCMSUM01 : ADCM summary dataset in a diabetes study |

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.
  • Complete programming of Rescue Medication Summary in a diabetes study
  • Involves creation of parameters to check if a subject reached a specific visit interval
  • Involves creation of parameters to check if a subject took rescue medication in the same intervals defined for visits above
  • Programming involves:
    • Creation of full template of visits using output statements
    • Creation of cartesian product to populate all parameters for all subjects
    • Usage of cartesian product to check if records fall in a specific interval
VARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENT
STUDYID Study Identifier _ ADSL.STUDYID
USUBJID Unique Subject Identifier _ ADSL.USUBJID
PARAM Parameter _ Populate as 'Baseline to Week 4 Visit' when PARAMCD='W4VIS'.
Populate as 'Week 4 to Week 12 Visit' when PARAMCD='W12VIS'.
Populate as 'Week 12 to Week 18 Visit' when PARAMCD='W18VIS'.
Populate as 'Week 18 to Week 26 Visit' when PARAMCD='W26VIS'.
Populate as 'Week 26 to Week 32 Visit' when PARAMCD='W32VIS'.
Populate as 'Week 32 to Week 39 Visit' when PARAMCD='W39VIS'.
Populate as 'Week 39 to Week 45 Visit' when PARAMCD='W45VIS'.
Populate as 'Week 45 to Week 52 Visit' when PARAMCD='W52VIS'.
Populate as 'Baseline to Week 4 Rescue Therapy' when PARAMCD='W4RESC'.
Populate as 'Week 4 to Week 12 Rescue Therapy' when PARAMCD='W12RESC'.
Populate as 'Week 12 to Week 18 Rescue Therapy' when PARAMCD='W18RESC'.
Populate as 'Week 18 to Week 26 Rescue Therapy' when PARAMCD='W26RESC'.
Populate as 'Week 26 to Week 32 Rescue Therapy' when PARAMCD='W32RESC'.
Populate as 'Week 32 to Week 39 Rescue Therapy' when PARAMCD='W39RESC'.
Populate as 'Week 39 to Week 45 Rescue Therapy' when PARAMCD='W45RESC'.
Populate as 'Week 45 to Week 52 Rescue Therapy' when PARAMCD='W52RESC'.
PARAMCD Parameter Code _ Create the following derived parameters for each subject in ADSL where TRTSDT is not null with PARAMCD values as listed below:
W4VIS
W12VIS
W18VIS
W26VIS
W32VIS
W39VIS
W45VIS
W52VIS
W54VIS
W4RESC
W12RESC
W18RESC
W26RESC
W32RESC
W39RESC
W45RESC
W52RESC
PARAMN Parameter (N) _ Populate as 101 when PARAMCD='W4VIS'.
Populate as 102 when PARAMCD='W12VIS'.
Populate as 103 when PARAMCD='W18VIS'.
Populate as 104 when PARAMCD='W26VIS'.
Populate as 105 when PARAMCD='W32VIS'.
Populate as 106 when PARAMCD='W39VIS'.
Populate as 107 when PARAMCD='W45VIS'.
Populate as 108 when PARAMCD='W52VIS'.
Populate as 201 when PARAMCD='W4RESC'.
Populate as 202 when PARAMCD='W12RESC'.
Populate as 203 when PARAMCD='W18RESC'.
Populate as 204 when PARAMCD='W26RESC'.
Populate as 205 when PARAMCD='W32RESC'.
Populate as 206 when PARAMCD='W39RESC'.
Populate as 207 when PARAMCD='W45RESC'.
Populate as 208 when PARAMCD='W52RESC'.
AVALC (PARAMCD=W4VIS) Analysis Value (C) _ Populate as "Y" if there exists a record in SV where 1<=SVSTDY<=57. Populate as "N" otherwise.
AVALC (PARAMCD=W12VIS) Analysis Value (C) _ Populate as "Y" if there exists a record in SV where 58<=SVSTDY<=106. Populate as "N" otherwise.
AVALC (PARAMCD=W18VIS) Analysis Value (C) _ Populate as "Y" if there exists a record in SV where 107<=SVSTDY<=155. Populate as "N" otherwise.
AVALC (PARAMCD=W26VIS) Analysis Value (C) _ Populate as "Y" if there exists a record in SV where 156<=SVSTDY<=204. Populate as "N" otherwise.
AVALC (PARAMCD=W32VIS) Analysis Value (C) _ Populate as "Y" if there exists a record in SV where 205<=SVSTDY<=250. Populate as "N" otherwise.
AVALC (PARAMCD=W39VIS) Analysis Value (C) _ Populate as "Y" if there exists a record in SV where 251<=SVSTDY<=295. Populate as "N" otherwise.
AVALC (PARAMCD=W45VIS) Analysis Value (C) _ Populate as "Y" if there exists a record in SV where 296<=SVSTDY<=341. Populate as "N" otherwise.
AVALC (PARAMCD=W52VIS) Analysis Value (C) _ Populate as "Y" if there exists a record in SV where 342<=SVSTDY<=372. Populate as "N" otherwise.
AVALC (PARAMCD=W4RESC) Analysis Value (C) _ Populate as "Y" if there exists a record in CM where RESCMED="Y" and 1<=CMSTDY<=57. Populate as "N" otherwise.
AVALC (PARAMCD=W12RESC) Analysis Value (C) _ Populate as "Y" if there exists a record in CM where RESCMED="Y" and 58<=CMSTDY<=106. Populate as "N" otherwise.
AVALC (PARAMCD=W18RESC) Analysis Value (C) _ Populate as "Y" if there exists a record in CM where RESCMED="Y" and 107<=CMSTDY<=155. Populate as "N" otherwise.
AVALC (PARAMCD=W26RESC) Analysis Value (C) _ Populate as "Y" if there exists a record in CM where RESCMED="Y" and 156<=CMSTDY<=204. Populate as "N" otherwise.
AVALC (PARAMCD=W32RESC) Analysis Value (C) _ Populate as "Y" if there exists a record in CM where RESCMED="Y" and 205<=CMSTDY<=250. Populate as "N" otherwise.
AVALC (PARAMCD=W39RESC) Analysis Value (C) _ Populate as "Y" if there exists a record in CM where RESCMED="Y" and 251<=CMSTDY<=295. Populate as "N" otherwise.
AVALC (PARAMCD=W45RESC) Analysis Value (C) _ Populate as "Y" if there exists a record in CM where RESCMED="Y" and 296<=CMSTDY<=341. Populate as "N" otherwise.
AVALC (PARAMCD=W52RESC) Analysis Value (C) _ Populate as "Y" if there exists a record in CM where RESCMED="Y" and 342<=CMSTDY<=372. Populate as "N" otherwise.
TRTSDT Date of First Exposure to Treatment _ ADSL.TRTSDT
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