Sponsor Specific Details: Shionogi & Co., LTD

Shionogi will list clinical studies that were,

• Shionogi sponsored Phase 1 to 4 interventional clinical studies in patients.
• used as part of a regulatory approval of new medicine or new indication in Japan (JP), the United States (US), and European Union (EU) except for regions where the regulatory submissions are not planed.

Clinical studies in following conditions will be excluded from the list:

• When there is a reasonable likelihood that individuals could be re-identified (for example, studies of very rare diseases, single centre studies, or studies with a very small number of patients.)
• Studies in which clinical data were collected subject to legal, contractual or consent provisions that prohibit or limit transfer to third parties.
• Where agreement to disclosure clinical data is not gained with a co-development/research/marketing/promotion partner for a product/medicine.

The access to clinical trial data may be limited or precluded in following cases:

• Where the research purpose does not include the public health improvement
• Where there is a potential conflict of interest or an actual/potential competitive risk.
• When the research proposal competes with the Shionogi publication plan
• Where there are any practical constraints to providing access to the data. (ex. issues related to size of databases)
• When the costs to retrieve data and documents from archives or to redact personally identifiable information from relevant documents or datasets are considerable.
• Where supporting documents are not in English.

When the medicine and the indication have received the regulatory approval in JP, US and EU on December 5th 2018 or later, and the primary manuscript describing the results has been accepted for publication.

Not applicable

Where available, the following anonymised patient level data and information is provided for each clinical study.

Raw dataset or SDTM datasets. These are the data collected for each patient in the clinical study. SDTM is the raw data mapped to CDISC standards.

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

Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.

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 methods of analysis, procedures for data handling and data displays (figures and tables) Shionogi used for the study.

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 study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA). Shionogi will not share case narratives. Appendices which contain individual patient level data are not included.

Redactions to this document will also be made to protect personal data of study participants, study personnel, Shionogi employees, and to protect Shionogi’s commercially confidential information, including intellectual property rights.

Researchers can enquire about the availability of data from Shionogi clinical studies that are not listed on the site before they submit a research proposal.

Researchers can enquire about access to clinical study documents only (without patient-level data, such as the Clinical Study Report) by completing the online enquiry form.

Shionogi will review the research proposal according to the criteria mentioned in sections "Studies listed", "Exceptions" and "Additional conditions for data access".

JAPIC (in Japan)
https://www.clinicaltrials.jp/cti-user/common/Top.jsp

ClinicalTrials.gov (in the United States)
http://ClinicalTrials.gov

EU Clinical Trial Register (in Europe)
https://www.clinicaltrialsregister.eu/ctr-search/search