Data record for adverse event case study: Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D)
University of Cambridge
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Waldron-Lynch, F., & TBC. (2016). Data record for adverse event case study: Adaptive study of IL-2 dose on regulatory T cells in Type 1 Diabetes (DILT1D) [Dataset]. https://www.repository.cam.ac.uk/handle/1810/253193
Supporting data for an adverse event case study, with the index case and controls identified and taken from DILT1D - article in progress, title TBC.
The DILT1D protocol is published - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4054640/
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 data that appears as (with near-final counts): Figures (6); Tables (1); Supplementary Files (2); Supplementary Figures (11); Supplementary Tables (1).
Additional datasets are available to show which participant(s), and which variable(s) from which dataset(s) were used to create each Figure and Table.
The source mechanistic [and clinical TBC] flow cytometry files (in .fcs 3.0 format) are also available, [with metadata formatted to MIFlowCyt standards [and deposited with flowrepository.org TBC]].
The complete list of datasets will be available as one of the Supplementary Files.
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 an Open Data repository, but is instead available on completion of a data access agreement at the authors' website - https://www-gene.cimr.cam.ac.uk/data/.
While the website should be checked for a more recent version, a representative licence for previous data releases (current at 11th January 2016) is available here.
An updated version of this dataset is detailed at https://doi.org/10.17863/CAM.7926.
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This work was supported by the EC, NIHR, Wellcome Trust [grant number (091157, 100140)], JDRF [grant number (9-2011-253)], European Union's 7th Framework Programme [grant number (FP7/2007-2013) under grant agreement no. 241447 (AIMI)].
This record's URL: https://www.repository.cam.ac.uk/handle/1810/253193
JDRF/Wellcome Trust DIL Data Access Agreement - sample uploaded here.