Supporting data for an adverse event case study, with the index case and controls identified and taken from the “Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D) trial”

The study was approved by the Health Research Authority, National Research Ethics Service, UK (13/EE/0020) and is registered at the International Standard Randomised Controlled Trial Number Register (ISRCTN27852285) and at ClinicalTrials.gov (NCT01827735). Data available is the anonymised individual-participant-level results aggregated to appear as: Figures (9); Supplementary Figures (3); Supplementary Tables (1) in "Capturing the systemic immune signature of a norovirus infection: an n-of-1 case study within a clinical trial". Additional datasets are available to show which participant(s), and which variable(s) from which dataset(s) were used to create each Figure. The paper describes the course of an adverse event observed in DILT1D, comparing the index case with other participants receiving similar (ultra-low) doses of IL-2, followed over the course of 2-3 months. While the index case is omitted from analyses reported in the main paper, the controls are not, and therefore there is some overlap with data available for the main study - see https://www.repository.cam.ac.uk/handle/1810/253110

While all obvious personal identifiers have been stripped from the individual-participant-level data, a case report cannot be anonymised sufficiently to be able to put it into the public domain without risk of participant identification. Therefore, it cannot be hosted by the University of Cambridge research repository, but is instead available on application to the DILT1D Data Access Committee, contacted via fw211@cam.ac.uk, and on completion of a Data Access Agreement. The Data Access Committee consists of: the Chief Investigator; the Senior Trial Statistician; and the independent Trial Chair; with additional independent advice from the University of Cambridge School of Clinical Medicine's Information Governance team. Applications will be judged on the following criteria: 1. Has the application been submitted by bona fide researchers? 2. Is the application's purpose in line with the original aims of the trial, and the consents given? 3. Does the application run the risk of producing information that may allow individual trial participants to be identified, or may prejudice the willingness of participants to join future trials? This record will be updated with publication details.