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Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial

Published Online: 2020-09-17

Published Print: 2020-12

Authors

James, Elizabeth C. https://orcid.org/0000-0002-0490-7211
Dunn, David https://orcid.org/0000-0003-1836-4446
Cook, Adrian D. https://orcid.org/0000-0003-4417-2632
Clamp, Andrew R. https://orcid.org/0000-0002-4200-0186
Sydes, Matthew R. https://orcid.org/0000-0002-9323-1371
Funding

Funding for this research was provided by:

Cancer Research UK (C1489/A12127)

Medical Research Council
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Text and Data Mining valid from 2020-09-17

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Article History

Received: 23 April 2020

Accepted: 31 August 2020

First Online: 17 September 2020

Ethics approval and consent to participate

: The London-Chelsea research ethics committee granted ethical approval for the main ICON8 trial in the UK. The trial also received ethical approval from appropriate national or local institutional review boards in other jurisdictions. No additional ethics approval was required for this methodological study.

: Not applicable.

: The authors declare that they have no relevant competing interests.

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