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Article History

Received: 30 November 2022

Accepted: 17 May 2023

First Online: 21 June 2023

Declarations

:

: We conducted a retrospective genetic study of peripheral neuropathy events using individual participant data from 14 previously completed randomized controlled trials. Detailed clinical trial protocols and results have been previously reported for IMmotion151 [], IMpassion130 [], IMpower110 []/130 []/131 []/132 []/150 []), IMpower133 [], IMvigor010 []/130 []/211 [], IMagyn050 [], IMspire170 [], and GO29779 [].All of the trials were sponsored by F. Hoffmann–La Roche/Genentech. The sponsor provided the study drugs and collaborated with the investigators across countries and study sites on the clinical trial and collection of the data. Each trial was conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines and with the principles of the Declaration of Helsinki. An independent data monitoring committee reviewed safety data from these studies.All patients provided informed consent for the main study. A subset of patients signed an optional Research Biosample Repository (RBR) Informed Consent Form (ICF) to provide whole blood samples for future research. By signing the optional RBR ICF, patients provided informed consent for study of inherited and non-inherited genetic variation from these whole blood samples. Whole genome sequencing data was collected from whole blood only from patients that signed the optional RBR ICF. Ethics Committees (EC) and Institutional Review Boards (IRB) at each study site for each clinical trial approved the clinical trial protocol, the main study ICF, and the RBR ICF.

: Not applicable.

: All authors are current employees of Genentech/F. Hoffmann–La Roche. ZK and TB are co-inventors on a patent application related to this work.