James A. Reiffel, MD - Novel Oral Anticoagulants - Figure 36
Pre-defined Populations in ROCKET AF
The previous Figure showed the results of the ITT analysis (ie, the results were analyzed on the basis of which drug each patient was prescribed). However there were 2 further pre-defined analyses (shown in this Figure):
- safety-on-treatment (all people in the ITT population who got at least one dose of the drug) and
- per-protocol (all patients in the safety population who did not have a major protocol violation, which was the overwhelming majority of the patients).[97]
Reiffel JA. Am J Med 2013; 126: 00-00.