- 12/28/17 - 1 form, 18 itemgroups, 126 items, 1 language
Itemgroups: SAE possible study endpoint, SAE to be adjudicated, SAE as non-adjudicated endpoint, Occurence of endpoints, Event adjudicated to be study endpoint, Report, Randomization, Serious Adverse Event, Intensity changes, Seriousness, Relevant concomitant/treatment medications, Relevant medical conditions / Risk factors, Relevant diagnostic results, Investigational product, Investigational product [hidden], Investigational product [hidden], General narrative comments, Non clinical