Improve Research Reproducibility A Bio-protocol resource
Concise Method
tooltip

Safety reporting

AD Alexandra Dipper
AS Anand Sundaralingam
EH Emma Hedley
ET Emma Tucker
PW Paul White
RB Rahul Bhatnagar
AM Andrew Moore
MD Melissa Dobson
RL Ramon Luengo-Fernandez
JM Janet Mills
SS Sandra Sowden
JH John E Harvey
LD Lee Dobson
RM Robert F Miller
MM Mohammed Munavvar
NR Najib Rahman
NM Nick Maskell
ask Ask a question
Favorite

Both study arms entail procedures which are standard of care and have associated recognised risks. The population of patients involved in TACTIC is one in which a high number of AEs are expected. Many of these will not be causally related to the investigational intervention, but rather a direct consequence of the patient’s underlying malignancy (which is an entry criteria).

The trial intervention is the combination of an IPC with TTP, therefore only AEs related to this IPC require expedited reporting. For participants in the standard care arm, serious adverse events (SAEs) will be reportable if related to the trial intervention and not a recognised procedural risk. To support assessment of relatedness and causality, a clearly defined list of anticipated events is included in the protocol.

Copyright and License information:  ©2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Do you have any questions about this protocol?

Post your question to gather feedback from the community. We will also invite the authors of this article to respond.

post Post a Question
0 Q&A