{"columns":["modifier_id","label","populations","unit_or_categories","kind","priority","rationale"],"rows":[["EM01","Baseline HbA1c","P01;P04;P05","percent","clinical","1","Glucose lowering effects grow with baseline HbA1c"],["EM02","Baseline BMI","P01;P02;P03;P04;P05;P07A;P07B;P08A;P08B;P09;P10;P11;P12;P15","kg/m2 (BMI standard deviation score in P03 and P04)","clinical","1","Weight effects and tolerability differ by adiposity"],["EM03","Background glucose lowering therapy","P01","stratum S0 to S4","clinical","1","Determines achievable HbA1c reduction and hypoglycemia risk"],["EM04","Diabetes duration","P01;P05","years","clinical","2","Beta cell reserve modifies glycemic response"],["EM05","Established cardiovascular disease","P01;P02","percent of participants","clinical","1","Modifies baseline risk and relative effects on cardiovascular outcomes"],["EM06","Baseline eGFR","P01;P08A;P08B","mL/min/1.73 m2","clinical","1","Modifies kidney outcomes and drug exposure"],["EM07","Age","All","years","clinical","2","General effect modifier and transportability"],["EM08","Sex","All","percent female","clinical","2","Weight loss differs by sex"],["EM09","Region or ancestry","All","percent Asian participants","clinical","2","Several programs ran in East Asian populations with different BMI thresholds"],["EM10","Trial duration","All","weeks","clinical","1","Weight effects accrue beyond 26 weeks"],["EM11","Lifestyle co-intervention intensity","P02;P03;P01","none; standard advice (counseling at visits); intensive behavioral therapy (structured program with frequent sessions or low calorie diet)","clinical","1","Intensive behavioral therapy shared by arms changes the response in the reference arm"],["EM12","Estimand","All","treatment policy; hypothetical or trial product; while on treatment","bias",null,"Not exchangeable; analyzed separately (see protocol)"],["EM13","Year of trial start","All","year","bias",null,"Proxy for changes in background care"],["EM14","Funding source","All","industry or other","bias",null,"Sponsorship bias"],["EM15","Blinding","All","open label or double blind","bias",null,"Subjective outcomes and adverse event ascertainment"],["EM16","Left ventricular ejection fraction","P07A;P07B","percent","clinical","1","Defines phenotype and prognosis"],["EM17","Albuminuria","P01;P08A;P08B","urine albumin to creatinine ratio (mg/g)","clinical","1","Modifies kidney risk and response"],["EM18","Baseline fibrosis stage","P09","NASH CRN stage F0 to F4","clinical","1","Modifies histological response and prognosis"],["EM19","Baseline AHI and positive airway pressure use","P10","events per hour; percent using PAP","clinical","1","PAP use changes measured AHI and the reference response"],["EM20","Amyloid status","P13A","percent amyloid positive","clinical","1","Defines Alzheimer pathology"],["EM21","Antipsychotic drug","P15","clozapine or olanzapine versus other","clinical","1","Weight gain liability differs by drug"],["EM22","Run in drug and dose","P02W","node of the run in regimen","clinical","1","Determines the starting weight trajectory at randomization"]]}