• Standard model: SDTM.
• Format: CDISC’s Dataset-JSON. Where SAS is used for analysis, SAS transport files (created with PROC CPORT) will be provided. Our de-dentification programs may create variable names/labels that are not compatible with v5 XPTs and will need to be abbreviated (and corresponding documentation will need to be updated).
• Patient identifiers (subject number): Scrambled consistently across all datasets to keep the patient-record relationship.
• Site identifier: Scrambled (consistently) or redacted.
• Further unique identifiers: Scrambled (consistently) or redacted.
• Risk of re-identification will be calculated using the following quasi-identifiers. Variables will be retained only if the risk of re-identification risk is acceptable:
  • Date of birth: Replaced with categorical age at screening.
  • Age: Categorized variable created with banding calculated following re-identification scoring.
  • Sex: Retained or redacted.
  • Race: Retained or redacted. In some cases, race can be partially redacted by combining race categories with low #s with the “Other” category in a new category called “DIOTHER”.
  • Ethnicity: Retained or redacted.
  • Country: Aggregated to continental level or redacted.
• Height/weight/body mass index/body surface area/weight circumference: Categorized variable created.
• Dates/Times related to study subject: Replaced with relative days or offset. Time remains unchanged.
• Comments, free text, and variables containing personally identifiable information (PII), e.g. names, initials: Redacted.
• Verbatim term of adverse events and medical history: Redacted.
• Verbatim term of concomitant medications: Removed. No replacement by coded dictionary terms due to license restrictions.

Clinical studies will also be listed for Astellas sponsored Phase 1 to 4 interventional clinical studies with a medicinal product in patients relating to terminated products. Terminated products are unapproved medicines for which clinical development is completely terminated on or after 01 January 2014.

• Clinical studies where data labels and/or supporting documents are not in English.
• Small studies, single-center studies, clinical studies of rare diseases or other studies where anonymization of these data is difficult to achieve.
• Studies where clinical data have been collected subject to legal, contractual or consent provisions that prohibit transfer to third parties, or in case of substantial conflicts of interest or actual or potential competitive risk, data access under this policy may be precluded.
• For products where Astellas has a co-research, co-development or co-marketing/co-promotion agreement, it is recognized that the responsibility for disclosure is dependent on the agreement between parties. Astellas will endeavor to gain agreement to list studies in these circumstances.

• It is Astellas policy to provide access to patient level data only after authorization or termination of the medicine and acceptance of the study for publication in the scientific literature.
• Whether Astellas has the legal authority to provide the data. For example, Astellas may not have the legal authority because the medicine has been out-licensed to another company.
• Whether Astellas considers it feasible to anonymize the data without compromising the privacy and confidentiality of research participants. For example, anonymization of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
• Whether Astellas considers that there are any practical constraints to providing access to the data.
• The resources (costs) for Astellas to retrieve data and documents from repositories and archives, anonymize data, and redact PII from relevant documents is signifigant.
• To comply with the United States (U.S.) Department of Justice (DOJ) 28 CFR Part 202, Astellas will review requests from Countries of Concern or Covered Persons on a case-by-case basis.

In rare cases, the limitations of the informed consent of study participants might not allow data sharing.

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

Protocol incorporating most recent amendment. This describes the objectives, design, methodology, statistical considerations, and organization of a clinical study.

Statistical analysis plan. This describes methods of analysis and procedures for data handling that Astellas used for the study report.

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

Clinical study report synopsis. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA).

Documents will be redacted to protect personal data of study participants, study personnel, Astellas employees, and to protect Astellas’ commercially confidential information, including intellectual property rights.