How to design the demographic tables in oncology studies for submission ? What factors should be included ?

How to design a demographic table? What factors should be included?


1. Talk with the clinicians, let them make decisions based on some clinical meanings.

For example, whether these baseline factors will impact the efficacy endpoints?

2. check the inclusion/exclusion criteria, make sure the enrolled patients meet the protocol criteria/meet the target population. 

For example, age, disease stage, prior treatment. 

For example, for breast cancer, subjects more than 65 years old then can be enrolled. 

3. check with the CRF DM page, DM table from previous studies, Adam specifications 


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