Aggregate Reporting

Date that defines the data cut-off for a periodic report (e.g., PBRER).

All safety data from trials and/or post-marketing up to a point in time; presented in PBRER and signal assessments.

Estimate of patient exposure (e.g., patient-years) for a product; used to contextualize AE counts.

Table of cases (key fields) for review or submission; used in aggregate reports and authority requests.

Summary tables (e.g., by SOC, seriousness) in periodic reports.

Summary of safety across all trials for a drug; part of submission dossier.

Statistical combination of safety data from multiple studies; used in signal assessment and PBRER.

Total number of cases over time; used in signal detection and PBRER.

Rate of reports (e.g., per 1000 patient-years); contextualizes counts.

Document summarizing safety data (e.g., for internal review or authority); not to be confused with SDS (chemical).

A supplementary document submitted after a periodic report to provide additional information, updated analyses, or responses to regulatory questions.

A yearly safety report required by some regulatory authorities, summarizing safety data and any relevant safety issues.

A structured evaluation in periodic reports weighing the therapeutic benefits against known and emerging risks to conclude on overall product value.

Regular safety reports during clinical development providing aggregate analysis of trial safety data to regulators and ethics committees.

The total of all safety data from first approval through the current data lock point, providing historical context.

The cutoff date for including data in a periodic safety report, after which no new data is added to that report.

An annual safety report for investigational drugs submitted during clinical development to regulatory authorities and ethics committees.

The date in the EU that determines the harmonized submission schedule for PSURs, as listed in the EURD list maintained by EMA.

Estimates of the number of patients or patient-time exposed to a medicinal product, providing context for interpreting adverse event data.

The date of first marketing authorization for a medicinal product anywhere in the world, used to calculate PSUR submission intervals.

Safety data from the period between the previous and current data lock points, representing new information since the last report.

A tabular presentation of individual case data, with each row representing one case and columns containing key data elements.

The FDA-specific periodic safety report format required for approved drugs, similar to PSUR but with US-specific requirements.

The ICH E2C(R2) format for periodic safety reports that emphasizes benefit-risk evaluation, replacing the previous PSUR format internationally.

Recommendations in a periodic report for updating product labeling or risk management measures based on safety findings.

A comprehensive assessment of the risk-benefit balance of a medicinal product submitted at defined intervals throughout its marketed life.

The EU electronic system for submission and storage of PSURs, enabling centralized access and assessment.

A summary of the identified risks, potential risks, and missing information for a medicinal product, forming the basis for pharmacovigilance planning.

The EU procedure where one member state assesses a PSUR on behalf of all member states where the product is authorized.

Aggregate tables presenting case counts by various parameters such as adverse event, seriousness, outcome, or system organ class.