Selection Tab for Increased Frequency Report

Field

Description

Select product by one of the following

Indicates the mode of selection of the product. Select the required Radio button. The Options are:

DRL Code

Product description

Approval number

DRL Code

Indicates the DRL code for the product by selecting the lookup page

Product description

Indicates the description of the product in the text field.

Approval

No.

Indicates the approval number for the product in the text field

Type

Indicates the approval type of the product with the associated list box. Choose from the Drop down menu.

Country

Indicates the country that approved the product with the associated list box. Choose from the Drop down menu.

Reporting

Indicates the period where the number of cases is compared with the past period as a date range (from date - to date).  If there is an increase in number of cases in this period, the increase in frequency is reported. Enter the dates in the text field.

Comparison

Indicates the period for which the number of reactions provides the basis for comparison as a date range (from date - to date). Enter the dates in the text field.

Market drug volume Reporting period

Indicates the volume of the drug that has been marketed in the reporting period. Enter the volume in the text field.

Comparison period

Indicates the volume of the product that has been marketed in the comparison period. Enter the volume in the text field.

Unit of volume

Indicates the unit of volume of the product in the text field.  The unit of volume should be the same in both the periods.

Count for authority Section - Include the following data on the report.

AEs term

Indicates the radio button 'Yes’ or 'No’. 'Yes’ will include the AE term in the report. 'No’ will omit the AE term.

Overdose cases

Indicates the radio button 'Yes’ or 'No’. Yes will include the overdose cases in the report.  'No’ will omit the overdose cases.

Death cases

Indicates the radio button 'Yes’ or 'No’. 'Yes’ will include the death cases in the report.  'No’ will omit the death cases.

Lack of effect cases

Indicates the radio button 'Yes’ or 'No’. 'Yes’ will include the lack of efficacy cases in the report.  'No’ will omit the lack of efficacy cases.

Field

Description

Group by

Indicate the manner in which the AEs are grouped by selecting the required Radio from the option:

• Drug name

• Approval number

• DRL code or

• First 8 characters of the DRL code.

Generate form

For each AER number that is printed in the reporting period, an FDA3500A or VAERS form can be generated.  Select the type of form to be printed, or indicate No Form. Radio buttons are provided to select the option.

Geographical grouping

Select the appropriate Radio button to indicate the Geographical grouping used to generate the report. The options are:

Domestic- will generate the report based on the cases that have occurred in USA.

Foreign- will generate the Increased Frequency Report based on the cases that have occurred outside USA.

Both- will generate the Increased Frequency Report based on the domestic and foreign cases.

Event grouping option

Select the appropriate Radio button to indicate the Event grouping option used to generate the report.  The options are:

Serious labeled- will generate the report based on only the serious labeled cases

Non-serious labeled- will generate the report based on the cases that are Non-serious labeled

All-   Generation of the report is based on the all the cases.

Formula used

Select the formula to be used to determine an increase in frequency. The options are:

• FDA formula- will determine the increase in frequency using the FDA formula.

• Poisson formula- will determine the increase in frequency using the Poisson formula.

• Arithmetic formula- will determine the increase in frequency using the arithmetic formula.

Select the required Radio button.

Print AER/summary description

For each AER number that is printed in the comparison period, the AER description or Summary description can be printed on the report.  Summary description will print the Summary description on the Increased Frequency Report.  AER description will print the AER description on the Increased Frequency Report. No indicates that no description is required. Radio buttons are provided to select the required option.