What Cases are Included in PBRER Section 6.2 and PBRER Section 6.3 of the ICH PSUR Report? (Doc ID 2149457.1)

Last updated on DECEMBER 08, 2023

Applies to:

Goal

The ICH PSUR report contains two Periodic Benefit Risk Evaluation Report (PBRER) sections:

• PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical trials
• PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources

1. Does the absence of a study drug cause events not to be counted in section 6.2?

2. What types of cases are programmatically excluded from section 6.2?

3. What types of cases are programmatically excluded from section 6.3?

4. Do sections 6.2 and 6.3 look at case assessments or event assessments?

5. In compiling the counts for sections 6.2 and 6.3, is the information in the Inclusion Criteria taken into account?  Dates are used from the Inclusion Criteria tab if they are blank for 6.2/6.3, but what about the other Inclusion criteria such as age range, etc?

6. Are there any other exclusions in 6.2 or 6.3 that are data driven? For example, if a study drug is not selected the events will not be in the listing for section 6.2; is there anything like that in the programming for 6.3?

Solution

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