Updates are available Correction dated 2023-01-23

Article History

Accepted: 18 October 2022

First Online: 24 December 2022

Change Date: 23 January 2023

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s40264-023-01272-w

Declarations

:

: This work was supported by TransCelerate BioPharma Inc.

: All authors, including John van Stekelenborg, Vijay Kara, Roman Haack, Ulrich Vogel, Anju Garg, Markus Krupp, Kate Gofman, Brian Dreyfus, Manfred Hauben, and Andrew Bate, declare no conflicts of interest. However, all authors affiliated with pharmaceutical companies are employees and, in some cases, stockholders of the companies. The views expressed in this article represent the authors' thoughts and are independent of their employers.

: This declaration is not applicable as no human participants were involved and no protected/personal health information (PHI) was used. The data used for this study were metadata related to case transmissions, not safety case data itself.

: Not applicable.

: Not applicable.

: TransCelerate ensured collection, anonymization, and aggregation of member company safety data transmissions were performed and coordinated by a third-party project manager. The resulting datasets will remain confidential. Please see Electronic Supplementary Material for more information regarding data collection.

: Not applicable.

: All authors contributed to the article's conception and design. All authors read and approved the final manuscript. Collection, anonymization, and aggregation of safety data were performed and coordinated by a third party project manager.