Review by Joseph Ross – 01/09/2020 – 4:53pm

Data Request Number: 2019-4071 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

Interesting study to compare change in HbA1c, all-cause mortality, micro- and macro-vascular complications, patient-reported symptoms and quality of life and specific adverse outcomes reported for Canagliflozin / SGLT2s including renal impairment, diabetic ketoacidosis, volume depletion, fournier’s gangrene and lower limb amputation relevant to diabetes reported in published articles versus those in CSRs. The authors seem to only be requesting access to the CSRs for purposes of their meta-analyses, in order to compare effect estimates generated from published data and from CSRs. Is that accurate? The authors should clarify if they are requesting access only to the CSRs, or instead to the IPD and CSRs in order to compare: published reports to IPD; published reports to CSRs; and/or IPD to CSRs.
In addition, the authors should clarify how they will interpret their comparisons. For a comparison of published reports to CSRs, for all of the many outcomes they’ve specified, do the numbers need to be an exact match to be considered equivalent, or within a certain % of one another, etc.?

Recommendation for this data request: Approve