Post-authorisation safety study to assess the risk of urinary tract malignancies in relation to empagliflozin exposure in patients with type 2 diabetes: a multi-database European study (PASS DiabCancer)

First published 16/12/2016

Last updated 31/10/2025

EU PAS number:

EUPAS16424

Study

Finalised

Documents

Study protocol

Initial protocol

ER-9521_protocol_1245-0097_version3

English (969.84 KB - PDF) View document

Updated protocol

1245-0097 Final protocol v8.0_Redacted.pdf

First published: 15/01/2025

English (2.68 MB - PDF) View document

Study results

1245-0097_Synopsis.pdf

English (246.17 KB - PDF) View document

Study report

Other information

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