When the stated criteria are satisfied.
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 ONO'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) ONO 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. Appendices which include patient level data are not included as these data are provided in the datasets ONO provide.
Researchers can enquire about the availability of data from ONO clinical studies that are not listed on the site before they submit a research proposal.