Company or Configured Study Cases

If the case is being evaluated in a configured study, the system displays all the Section 6.2 case series that are part of study configuration for the product and study being evaluated. Counts are broken down into the following categories:

• Blinded:

  • If the study and case are both blinded, the system prints the count under Blinded.

  • If the case is blinded (even if study was unblinded), the system prints the count under Blinded.

  • If the case is unblinded (but the study is blinded) and you do not have the privilege to see unblinded data, the system prints the count under Blinded.

  • If you have access to the unblinded data and case is unblinded (but the study is blinded), or case and study both are unblinded, the system shows the counts under their respective categories if you choose to view the unblinded data; otherwise the system prints it under Blinded.

• Investigational Medicinal Product (IMP): If the target product is of one of the suspect products in the study case, the system counts these cases under Investigational Medicinal Product.

• Active Comparator: If the target product is NOT one of the suspect products in the case, and the product type attribute for the suspect product available in the study is either an IMP or Comparator, the system prints it under the Comparator column.

• Placebo: If the target product is part of the study but is not one of the suspect products in the case, and the product type attribute for the suspect product available in the case is identified as Placebo in the study configuration, the system counts the case as a Placebo. You can use User Exits to classify different drugs under the Placebo category.

• No Study Drug Given: This column allows for retrieval of 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. The system prints any study drug available in the case having product type defined as No Study Drug Given under No Study Drug Given column.

• Additional Study Drug OR No product Type Configured:

  • If the study configuration does not include the product type for that product, or is marked as Additional Study Drug, the system considers the product type as Investigational Medicinal Product if it is one of the target products and is also a suspect product in the case.

  • If the suspect product in the case is not part of the target product list, the system counts it as a Comparator. You can also use the user exits feature for categorizing products under the Investigational Medicinal Product, Comparator, Blinded, or Placebo columns in the temporary tables.

This tabulation also uses the parameter Print Serious Adverse Events or Reactions.

• Print All Events: The summary tabulation displays all events present in the cases lying within the reporting period. The in period flag is not used. This is the default value.

• Print only In Period Events: This summary tabulation displays only events added within the reporting period. Events in the cases with Follow-up data that does not fall into the reporting period are not considered.