Count Breakdown in Tabulations based on IMP, Comparator, Placebo, and Blinded

All DSUR tabulations provide serious events counts broken down by SOC and PT. To tabulate based on medicinal product, active comparators and placebo, the Oracle Argus Safety Console Study Configuration identifies a product type as placebo, comparator, or an investigational medicinal product.

Note:

You must configure all studies with the Product Type attribute to get the correct data.

The Oracle Argus Safety Console study configuration classifies the different product type counts.

The system evaluates the list of cases applicable for the DSUR based on the main inclusion criteria present on the CTPR configuration screen to generate a main case series and all cases corresponding to configured licenses or studies for generating the cumulative case series. If multiple licenses or studies are configured on the CTPR configuration screen, the system retrieves the cases of all configured licenses or studies.

Serious study cases are identified from the main and cumulative case series generated using the CTPR configuration.

For each case in the main cumulative case series, the system prints a summary tabulation count broken down by SOC in the internationally agreed order, followed by PTs in rows.

After classifying counts into Medicinal Product, Blinded, Comparator and Placebo, the system breaks the counts down by the actual treatment received by the patient.

For each case, the system counts only serious events under the following categories.

For each Company or Configured Study case, the system counts:

• No Study Drug Given: This column lets you retrieve Serious Adverse Events that occurred from the moment the patient signed the informed consent form to the first administration of study medication where no actual study medication was given to the patient.

• Additional Study Drug: Also known as background therapy drugs, these are given with IMPs or comparators of a study and do not impact the categorization logic of a case into different categories. All drugs marked as Additional Study Drugs in Oracle Argus Safety Console do not impact the case categorization. The system displays these drugs in the reports as part of the treatment field without affecting categorization logic.

Using the configuration of the study to which each case belongs, the system classifies the cases into the following categories based on the product type attribute of the study configuration and print counts for each category:

• Blinded:

  • If the study and the case are both blinded, the system prints the count under Blinded.
  • If the case is blinded (even if study is unblinded), it appears under Blinded.
  • If the case is unblinded (but the study is blinded) and you do not have access to unblinded data, the count appears under Blinded.
  • If you do not have access to unblinded data, the count appears under Blinded.
  • For a blinded case having blinded and open label therapy drugs, the case is counted under Blinded category.

• Investigational Medicinal Product or Study Drug: A case falls into the Investigational Product category if the case and study are not blinded and the product type in the study configuration is identified as Investigational Product.

  If the case is unblinded (but the study is blinded) and you have access to unblinded data, and the product is identified as an Investigational Product, then the system prints the count under the medicinal product. The medicinal product count is broken down into the actual treatments given to patients for the corresponding case.

  A suspect product that is also an Investigational Product as identified by the study configuration appears under the Investigational Product Name column, and the count of all serious events cases where the same product is used as a treatment is added under this column.

  When there are multiple suspect drugs in a case and they are classified as IMP in the study configuration, the system prints the count under the combined product treatment. All such cases are counted under the combined products that are part of the study.

  The product combination for counts is unique in a report. Based on the number of licenses and studies selected, there may be many combinations. There could be the following scenario for investigational products:

  Investigational Product (Including Combinational Therapy):

  Only study drugs are part of the DSUR treatment list. The following combinations of treatments can appear:

  Drug A + Drug B: Both Drug A and Drug B are identified as suspect study products in the case and are identified as Investigational Product in the corresponding study configuration.

  Drug A or Drug B: Only one of the drugs from the case is identified as a suspect study and this drug is identified as an Investigational Product in the study configuration.

  Drug A + Placebo: When multiple drugs are identified as suspect product in the case, and these are part of the study, and some drugs are identified as Investigational Products in the study configuration and others as Placebo, the system prints the count of such scenarios under Drug A or Drug A + Drug B only, without adding the placebo drug name.

  Drug A + Drug B: Drug A is identified as a suspect study product in the case and as an Investigational Product, and Drug B is identified as a suspect study product in the case and as an Additional Study Drug in the corresponding study configuration.

  Investigational Drug + Comparator: When multiple drugs are identified as suspect products in the case, and these are part of the study, and some drugs are identified as Investigational Products in the study configuration and others as Comparators, the system prints the count of such scenarios under the Investigational Product count only.

• Active Comparator: There may be cases where multiple suspect drugs are part of the case and two or more of those drugs are classified as comparators in the study configuration. Serious events of all such cases are counted under the combined products that are part of the study.

  A case falls into the Active Comparator category if the study configuration identifies the suspect product as type Comparator in the study configuration.

  If the case is unblinded (but the study is blinded) and you have access to unblinded data, the system prints the count under Comparator. This column has sub columns based on the actual treatments that were given to patients and were identified as Comparators in the corresponding study.

  Comparator (Combinational Therapy):

  The following combinations can appear under the Comparator counts:

  Drug X + Drug Y: Both Drug X and Drug Y are identified as suspect study products in the case and are identified as Comparator Products in the corresponding study configuration.

  Drug X or Drug Y: Only one of the drugs from the case is identified as a suspect study drug, and this drug is identified as a Comparator Product in the study configuration.

  Drug X + Placebo: When some drugs that are part of the study are identified as Suspect Products in the case, some as Comparator Products and others as Placebos in the study configuration, the system prints the count of such scenarios under Drug X OR Drug X + Drug Y only, without adding the placebo drug name.

  Drug X + Drug Y: Drug X is identified as a suspect study product in this case and is identified as a Comparator Product, and Drug Y is identified as a suspect study product and as an Additional Study Drug in the corresponding study configuration.

• Placebo: For a drug identified as the Placebo type, the system prints the count under Placebo. If multiple placebos are part of the case, they are shown under the heading of Placebo only without showing multiple Placebos in the summary tabulation.
• No Study Drug Given: For a drug identified as the No Study Drug Given type, the report prints the count under this category without printing the name of configured drug. This column lets you retrieve Serious Adverse Events that occurred from the moment the patient signed the informed consent to first administration of study medication, where no actual study medication was given to the patient.