A summary of the results of a clinical trial entered into the Roche results database will typically include the following fields:

Title of study: Study title as captured in the synopsis of the clinical study report.

Protocol number: A unique identification number assigned to a Roche sponsored trial. Each study has a unique number. Even if multiple studies are conducted using the same drug or diagnostic product, they will each have a unique number. A trial published in both the trial registry and the results database will have the same protocol number.

Sponsor: Name of the sponsoring organization(s) that initiated the clinical investigation and which takes responsibility for the clinical trial.

Product name: Common name for the product being tested in a clinical trial.

Generic name: Precise generic name of the product being tested in a clinical trial.

Therapeutic area or approved indication: Targeted disease area for the clinical trial and/or indication(s) for which the drug has been approved for use.

Clinical study summary: Scientific summary of the study.

Study center(s): Summary of study centers taking part in the clinical trial.

Publications: List of key publications associated with the results of the clinical trial.

Phase of development: See "Phase Definitions" section of this web site.

Objectives: A summary of the primary and secondary objectives of the clinical study.

Methodology: A scientific summary of the methodology used to conduct the clinical trial.

Number of patients (planned/analyzed): Number of planned and analyzed patients in the clinical study.

Diagnosis and main criteria for inclusion: Description of the diagnosis and other main criteria for the inclusion of participants in the clinical study.

Test product, dose and mode of administration or test procedure: Description of product tested, dose level and mode of administering the product, or a description of the test procedure.

Duration of treatment: Length of time associated with treatment in the clinical trial.

Reference therapy, does and mode of administration or reference procedure:  Description of the reference therapy, dose and mode of administering that therapy if applicable, or a description of the reference procedure.

Criteria for evaluation: Scientific criteria used to evaluate the outcomes of the clinical trial. Can include efficacy and safety criteria.

Statistical methods: Summary of the statistical methodology used to evaluate data from the clinical trial.

Summary: Scientific summary of the results from the clinical trial. Can include efficacy, safety, pharmacokinetic and other results.

Conclusions: Conclusions supported by the results of the clinical trial.

Date of report: Date the clinical study report was completed.