Sponsor Specific Details: Takeda

Clinical trials will be listed for Takeda-sponsored Phase 1-4 interventional trials supporting approved products as described below.

Commercially available new medicines or vaccines products that have received initial marketing approval since 01 January 2005 as follows:

• US and EU approval.
• US or EU approval (when regulatory submissions in both regions are not planned).
• Japan approval (when US or EU regulatory submissions are not planned).

Clinical trials will also be listed for Takeda-sponsored Phase 1-4 interventional trials relating to terminated compoundsi.e., terminated for all indications, all formulations, and all regions. Terminated compounds are unapproved medicines or vaccines for which clinical development is completely terminated on or after 01 January 2014.

Takeda will only share clinical datai.e., patient level data and/or supporting clinical documents when it is feasible to anonymize the data without compromising the privacy of trial participants. This may affect small clinical trials of rare diseases or trials conducted in a very small, easily identifiable patient population, which will be reviewed on a case-by-case basis. Prematurely discontinued trials that have insufficient enrollment/exposure to warrant analysis may not be listed. Interim data from completed or ongoing clinical trials will generally not be shared.

In rare cases, information may be restricted by Takeda in order to protect commercially confidential information (CCI) and intellectual property (IP) rights.

Takeda Consumer Healthcare products will not be subject to data sharing.

Clinical trials will be eligible for listing once the above criteria are met and the primary manuscript has been accepted for publicationIn cases where publication is not achieved or sought, trials will be listed within 2 years of trial completion.

Clinical trials supporting subsequent local approvals (including registration trials that specifically support approval in Japan), new indications, combination products, or major formulation changes for products that received initial approval since 01 January 2005 will be eligible for listing after the corresponding regulatory approvals have been achieved.

Takeda will regularly update this list to add trials meeting the criteria. For in-scope trials that are not yet listed, Takeda will assess the feasibility of data provision as part of the review of enquiries.

Data sharing is constrained by the requirements of the informed consent obtained at the time each clinical trial was conducted. In general, new research conducted on shared data must assess the specific medicine, disease or objective that was assessed in the original trial. For Takeda clinical trials initiated after this policy is enacted, patients will be asked to give permission for broader research beyond the original trial, so that other research may be possible with these data.

Where data is subject to legal, contractual, or consent provisions that restrict transfer to third parties, data access may be precluded.

Other practical constraints to providing access to the data may also preclude sharing.

Where available, the following anonymized patient level data and/or supporting documents are provided for each clinical trial. Information/documents will not be translated and in rare instances practical issues relating to redaction and availability of non-English documents may limit sharing.

Raw dataset. This is the data collected for each patient in the clinical trial.

Analysis-ready dataset. This is the dataset used for Takeda's analysis.

Protocols. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical trial and information about all amendments.

Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.

Reporting and analysis plan. This describes statistical analysis plans that include methods of analysis, procedures for data handling and data displays (figures and tables) that Takeda used for the trial.

Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.

Clinical study report. This is the report of efficacy and safety data from the trial. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data are generally not included as these data are provided in the datasets Takeda provides.

Documents will be redacted to protect personal data of trial participants, trial personnel, and Takeda employees (consistent with applicable privacy laws/regulations), and to protect Takeda's CCI and IP rights when required. Takeda will not share case narratives, documentation for event adjudication, imaging data (e.g., x-rays, MRI scans, etc.), genetic data, or other information that Takeda considers may compromise trial participant privacy.

Takeda accepts enquiries regarding the availability of patient-level data from clinical trials that are not yet listed on this site but are within the scope of Takeda's data sharing policies via the Enquiry Facility.

Takeda also accepts enquiries for clinical study report document-only access (consistent with the above data sharing policies) via the Enquiry Facility.

Enquiries for patient-level data and clinical study reports (documents-only) will be reviewed to assess if they relate to clinical trials that are within the scope of Takeda's data sharing policies (as outlined above).

www.TakedaClinicalTrials.com