Report Objective

The main objectives of a Development Safety Update Report (DSUR) are to present a comprehensive annual review, and evaluate pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed, by:

• Examining whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the investigational drug's safety.

• Describing new safety issues that could have an impact on the protection of clinical trial subjects.

• Summarizing current understanding and managing identified and potential risks.

• Providing an update on the status of the clinical investigation or development program and study results.

The main focus of the DSUR is data and findings from international clinical trials of drugs under investigation, irrespective of whether they have marketing approval. Because clinical development of a drug frequently continues after the marketing approval, relevant information from post-marketing studies is also included. The report concentrates on the investigational drug, providing information on comparators only where relevant to the safety of trial subjects.

The DSUR provides safety information from all ongoing clinical trials and studies that the sponsor is conducting or has completed during the review period, including:

• Clinical trials using an investigational drug.

• Clinical trials conducted using marketed drugs in approved indications.

• Therapeutic use of an investigational drug (such as expanded access programs, compassionate use programs, or particular patient use).

• Clinical trials conducted to support changes in the manufacturing process of medicinal products.

The DSUR presents important clinical safety information through:

• Interval line listings of the SARs that were reported to the sponsor during the period covered by the DSUR.

• Cumulative summary tabulations of serious adverse events that have been reported to the sponsor since the DIBD.

For information on report parameters, refer to Report Parameters and their Definitions.