Reporting of exploratory endpoints

[ABR]

Do results of exploratory endpoints need to be reported within the same clinical study report as the primary and secondary endpoint data?

[a123456]

Good idea to read the ICH E3 guidance on CSR. "11.4.7 Efficacy Conclusions
The important conclusions concerning efficacy should be concisely described, considering primary and secondary end points, pre-specified and alternative statistical approaches and results of exploratory analyses."


There is a also very good ICH E3 Q & A document (2012) that might be useful.
For instance a reply to this Q: Specifically, what are the options for submission of data for topics such as pharmacokinetics, pharmacodynamics, pharmacogenomics (genomic markers), gene therapy, stem cells, biomarkers, devices, Quality of Life, Assay Validation, Data Monitoring/Review Committees, Electrocardiogram, other Safety reports, images, pictures/scans, diagnostic tests for individualized therapy, and patient-reported outcomes?