Related Experiment Video
Updated: Jun 15, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Noninferiority trial design and analysis with an ordered three-level categorical endpoint
1Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 20892, USA. ebrittain@niaid.nih.gov
Abstract:
This paper extends standard methodology for noninferiority trial design from a binary endpoint to an ordered three-level endpoint, such as "success," "intermediate," and "failure." A metric that summarizes outcome on this endpoint is proposed, and the corresponding sample size requirements are presented. This ordered endpoint can be collapsed into two different binary endpoints, respectively lumping "intermediate" outcomes with "success" or with "failure." We describe how the ordered three-level endpoint compares with these two binary endpoints with respect to the noninferiority margin and sample size requirements.
Related Concept Videos
Comparing the Survival Analysis of Two or More Groups
Friedman Two-way Analysis of Variance by Ranks
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
The Mantel-Cox Log-Rank Test
Ordinal Level of Measurement
Data measured using an ordinal scale are similar to nominal scale data, but there is one major difference. The ordinal scale data can be ordered. An example of ordinal scale data is a list of the top five national parks in the...

