List of Abbreviations

Authors
Affiliation
Abbreviation Expansion
BICR Blinded Independent Central Review
CDISC Clinical Data Interchange Standards Consortium
CI Confidence Interval
CR Complete Response
DCR Disease Control Rate
DOR Duration of Response
EMA European Medicines Agency
FDA Food and Drug Administration
HR Hazard Ratio
HTD Historical Trial Data
IRR Inter-Rater Reliability
LME Linear Mixed Effects
NCT National Clinical Trial
NHST Null Hypothesis Significance Testing
ORR Objective Response Rate
OS Overall Survival
PD Progressive Disease
PFS Progression-Free Survival
PR Partial Response
PSOC Placebo and Standard of Care
RCT Randomized Controlled Trial
RECIST Response Evaluation Criteria in Solid Tumors
RS Disease Response Domain
SD Stable Disease
SDTM Study Data Tabulation Model
SLD Sum of Longest Diameters
TOST Two One-Sided Tests
TR Tumor Results Domain
TTP Time to Progression
TTR Time to Response
TU Tumor Domain
WHO World Health Organization
df degrees of freedom
Table 1: Table of Abbreviations