{"columns":["outcome_id","population_ids","label","definition","type","model_scale","direction","importance","nrs_synthesis","rare_outcome","threshold_scale","threshold","threshold_unit","absolute_horizon_weeks","mapping_rules"],"rows":[["O01","P01;P04;P05","HbA1c change","Change in glycated hemoglobin from baseline","continuous","MD","lower_better","critical","no","no","absolute","0.3","percentage points",null,"Values in mmol/mol are converted to percent (NGSP)."],["O02","P01","Body weight change in kilograms (diabetes)","Change in body weight from baseline in kilograms","continuous","MD","lower_better","critical","no","no","absolute","2","kg",null,null],["O03","P01","HbA1c below 7 percent","Proportion with HbA1c below 7.0 percent (53 mmol/mol)","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,null],["O04","P01;P04;P05","Level 2 or 3 hypoglycemia (participants)","Participants with at least one level 2 (glucose below 3.0 mmol/L) or level 3 (severe; needing assistance) event","binary","log_hazard_cloglog","lower_better","important","no","no","absolute","10","per 1000","52","Pre 2017 categories map as: confirmed below 3.1 mmol/L (56 mg/dL) to level 2; severe or major (third party assistance) to level 3; documented symptomatic above 3.0 mmol/L is not mapped."],["O04B","P01;P04;P05","Level 2 or 3 hypoglycemia (episode rate)","Episodes per participant year (reported rate ratios with their standard errors only)","count","log_rate","lower_better","important","no","no","relative","1.25","rate ratio",null,"Only reported log rate ratios with standard errors are synthesized; a count model with a dispersion prior would require an amendment."],["O05","P01;P02","Systolic blood pressure change","Change in systolic blood pressure","continuous","MD","lower_better","important","no","no","absolute","2","mmHg",null,null],["O06","P05","Total daily insulin dose change","Change in total daily insulin dose","continuous","MD","lower_better","important","no","no","absolute","0.1","units per kg per day",null,"Doses in units per day are converted using baseline weight when reported."],["O10","P01;P02;P03","Percent body weight change","Percent change in body weight from baseline","continuous","MD","lower_better","critical","no","no","absolute","2.5","percentage points",null,null],["O10B","P12;P15","Percent body weight change (short trials)","Percent change in body weight from baseline in populations whose trials are 12 to 52 weeks long","continuous","MD","lower_better","critical","no","no","absolute","2.5","percentage points",null,null],["O11A","P01;P02","Weight loss of 5 percent or more","Proportion losing at least 5 percent of baseline weight","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,null],["O11B","P01;P02","Weight loss of 10 percent or more","Proportion losing at least 10 percent of baseline weight","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,null],["O11C","P01;P02","Weight loss of 15 percent or more","Proportion losing at least 15 percent of baseline weight","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,null],["O11D","P01;P02","Weight loss of 20 percent or more","Proportion losing at least 20 percent of baseline weight","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,null],["O11E","P01;P02","Weight loss of 25 percent or more","Proportion losing at least 25 percent of baseline weight","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,null],["O12","P02W","Percent body weight change after randomization in maintenance trials","Percent change in body weight from randomization","continuous","MD","lower_better","critical","no","no","absolute","2.5","percentage points",null,null],["O13A","P03","BMI standard deviation score change","Change in BMI SDS (z score)","continuous","MD","lower_better","critical","no","no","absolute","0.2","SDS units",null,null],["O13B","P03","Percent BMI change","Percent change in BMI; used only when BMI SDS is not reported","continuous","MD","lower_better","important","no","no","absolute","3","percentage points",null,"Never pooled with O13A."],["O14","P02;P06","Progression to type 2 diabetes","Incident type 2 diabetes","time_to_event","log_hazard","lower_better","critical","no","no","absolute","10","per 1000","156",null],["O20","P01;P02;P07A;P07B;P08A;P08B","All cause mortality","Death from any cause","time_to_event","log_hazard","lower_better","critical","no","no","absolute","5","per 1000","156",null],["O21","P01;P02;P07A;P07B;P08A;P08B","Three point MACE","Cardiovascular death; nonfatal myocardial infarction; nonfatal stroke (adjudicated preferred)","time_to_event","log_hazard","lower_better","critical","no","no","absolute","10","per 1000","156","Three point MACE plus hospitalization for unstable angina maps to O21B. Other expanded composites are described and not pooled."],["O21B","P01;P02;P07A;P07B","Four point MACE including unstable angina","Three point MACE plus hospitalization for unstable angina (for example the ELIXA primary endpoint)","time_to_event","log_hazard","lower_better","important","no","no","absolute","10","per 1000","156","Other expanded composites (for example adding revascularization) are described and not pooled."],["O22","P01;P02","Kidney composite outcome","Kidney failure; sustained eGFR decline of at least 50 percent; or kidney death","time_to_event","log_hazard","lower_better","critical","no","no","absolute","10","per 1000","156","Pooled only across trials with the same component set and threshold; doubling of serum creatinine (about a 57 percent eGFR decline) is O22C, not O22. Never pooled with O22B to O22E."],["O22B","P01;P02;P08A;P08B","Kidney composite with 40 percent eGFR decline","Kidney failure; sustained eGFR decline of at least 40 percent; or kidney death","time_to_event","log_hazard","lower_better","important","no","no","absolute","10","per 1000","156","Pooled only across trials with the same component set. Never pooled with O22 or O22C to O22E."],["O22C","P01;P02;P08A;P08B","Kidney composite with doubling of serum creatinine","Kidney failure; doubling of serum creatinine (sustained); or kidney death","time_to_event","log_hazard","lower_better","important","no","no","absolute","10","per 1000","156","Pooled only across trials with the same component set. Never pooled with O22; O22B; O22D or O22E."],["O22D","P01;P02;P08A;P08B","Kidney composite including cardiovascular death","Any kidney composite that also includes cardiovascular death (for example the FLOW primary endpoint)","time_to_event","log_hazard","lower_better","important","no","no","absolute","10","per 1000","156","O22D is any kidney composite that includes cardiovascular death; including when it also includes albuminuria or a smaller eGFR decline. Trials are pooled only within a definition stratum that has the same component set and the same eGFR or creatinine threshold. A composite without cardiovascular death is O22; O22B; O22C; O50 or O22E."],["O22E","P01;P02;P08A;P08B","Kidney composite including albuminuria or smaller eGFR declines","Kidney composites that include new onset persistent macroalbuminuria or an eGFR decline threshold below 40 percent (for example LEADER; REWIND; SELECT)","time_to_event","log_hazard","lower_better","important","no","no","absolute","10","per 1000","156","O22E is a kidney composite that includes new onset persistent macroalbuminuria or an eGFR decline below 40 percent and does not include cardiovascular death. Trials are pooled only when the component set and thresholds are identical. When the same trial also reports a composite without albuminuria; that result is mapped by its components: O22; O22B; O22C or O50 when cardiovascular death is absent and O22D when it is present."],["O23","P01;P02;P07A;P07B;P08A;P08B","Hospitalization for heart failure","First hospitalization for heart failure","time_to_event","log_hazard","lower_better","critical","no","no","absolute","5","per 1000","156","Composites that add urgent heart failure visits are O23B."],["O23B","P01;P02;P07A;P07B;P08A;P08B","Heart failure events","Hospitalization or urgent visit for heart failure","time_to_event","log_hazard","lower_better","important","no","no","absolute","5","per 1000","156",null],["O24A","All","SF-36 physical component summary change","Change in the SF-36 (or SF-12) physical component summary score","continuous","MD","higher_better","important","no","no","absolute","3","points",null,null],["O24B","All","Physical functioning (any instrument)","Change in a physical functioning score (for example SF-36 physical functioning or IWQOL-Lite-CT physical function) when instruments differ across trials","continuous","SMD","higher_better","important","no","no","absolute","0.2","SMD",null,"Direction aligned per instrument; only physical functioning constructs are pooled; used only when O24A cannot be."],["O24C","All","Health related quality of life total score (any instrument)","Change in a generic or weight or disease specific HRQoL total score when instruments differ across trials","continuous","SMD","higher_better","important","no","no","absolute","0.2","SMD",null,"Direction aligned per instrument; only total HRQoL scores are pooled; never pooled with O24B."],["O25","All","Serious adverse events","Participants with at least one serious adverse event","binary","log_hazard_cloglog","lower_better","critical","no","no","absolute","10","per 1000","52",null],["O26","All","Discontinuation due to adverse events","Participants who discontinued study drug because of an adverse event","binary","log_hazard_cloglog","lower_better","critical","no","no","absolute","10","per 1000","52",null],["O27A","All","Nausea","Participants with at least one nausea event","binary","log_hazard_cloglog","lower_better","important","no","no","absolute","50","per 1000","52",null],["O27B","All","Vomiting","Participants with at least one vomiting event","binary","log_hazard_cloglog","lower_better","important","no","no","absolute","50","per 1000","52",null],["O27C","All","Diarrhea","Participants with at least one diarrhea event","binary","log_hazard_cloglog","lower_better","important","no","no","absolute","50","per 1000","52",null],["O27D","All","Constipation","Participants with at least one constipation event","binary","log_hazard_cloglog","lower_better","important","no","no","absolute","50","per 1000","52",null],["O27E","All","Discontinuation due to gastrointestinal adverse events","Participants who discontinued study drug because of a gastrointestinal adverse event","binary","log_hazard_cloglog","lower_better","important","no","no","absolute","10","per 1000","52",null],["O28","All","Gallbladder and biliary disease","Cholelithiasis; cholecystitis; or other gallbladder or biliary events","binary","log_hazard_cloglog","lower_better","important","yes","no","absolute","5","per 1000","52",null],["O29","All","Acute pancreatitis","Adjudicated acute pancreatitis (investigator reported in a sensitivity analysis)","binary","log_hazard_cloglog","lower_better","important","yes","yes","relative","1.25","hazard ratio","52",null],["O30","P05","Diabetic ketoacidosis","Participants with at least one episode of diabetic ketoacidosis","binary","log_hazard_cloglog","lower_better","critical","no","no","absolute","5","per 1000","52",null],["O31","P05","Severe hypoglycemia (type 1 diabetes)","Participants with at least one level 3 hypoglycemia event","binary","log_hazard_cloglog","lower_better","critical","no","no","absolute","10","per 1000","52",null],["O32A","All","Medullary thyroid carcinoma","Medullary thyroid carcinoma (C cell hyperplasia recorded separately)","binary","log_hazard_cloglog","lower_better","important","yes","yes","relative","1.25","hazard ratio","156",null],["O32B","All","Thyroid cancer (any)","Any thyroid cancer","binary","log_hazard_cloglog","lower_better","important","yes","yes","relative","1.25","hazard ratio","156",null],["O33","P01","Diabetic retinopathy complications","Retinopathy complications as defined by the trial (photocoagulation; vitreous hemorrhage; blindness; intravitreal therapy)","binary","log_hazard_cloglog","lower_better","important","yes","no","absolute","5","per 1000","104",null],["O34","All","Nonarteritic anterior ischemic optic neuropathy","NAION","binary","log_hazard_cloglog","lower_better","important","yes","yes","relative","1.25","hazard ratio","156",null],["O35A","All","Suicidal ideation or behavior","Suicidal ideation or behavior (C-SSRS or adverse event reports)","binary","log_hazard_cloglog","lower_better","important","yes","no","absolute","5","per 1000","52",null],["O35B","All","Death by suicide","Completed suicide","binary","log_hazard_cloglog","lower_better","critical","yes","yes","relative","1.25","hazard ratio","156",null],["O36A","All","Pulmonary aspiration","Pulmonary aspiration during anesthesia or sedation (risk per procedure)","binary","log_odds","lower_better","important","yes","yes","relative","1.25","odds ratio",null,"Risk per procedure; nonrandomized evidence mainly."],["O36B","All","Retained gastric content","Retained gastric content at endoscopy or anesthesia (risk per procedure)","binary","log_odds","lower_better","important","yes","no","absolute","50","per 1000 procedures",null,"Risk per procedure. Never pooled with O36A."],["O37A","All","Gastroparesis","Gastroparesis diagnosis","binary","log_hazard_cloglog","lower_better","important","yes","yes","relative","1.25","hazard ratio","52",null],["O37B","All","Intestinal obstruction or ileus","Bowel obstruction or ileus","binary","log_hazard_cloglog","lower_better","important","yes","yes","relative","1.25","hazard ratio","52",null],["O38","All","Pancreatic cancer","Pancreatic cancer","binary","log_hazard_cloglog","lower_better","important","yes","yes","relative","1.25","hazard ratio","156",null],["O39","All","Any cancer","Any incident malignancy excluding nonmelanoma skin cancer","binary","log_hazard_cloglog","lower_better","important","yes","no","absolute","5","per 1000","156",null],["O40","P07A;P07B","Cardiovascular death or heart failure events","Composite of cardiovascular death or heart failure events","time_to_event","log_hazard","lower_better","critical","no","no","absolute","10","per 1000","52",null],["O41","P07A;P07B","KCCQ clinical summary score change","Change in Kansas City Cardiomyopathy Questionnaire clinical summary score","continuous","MD","higher_better","critical","no","no","absolute","5","points",null,null],["O50","P08A;P08B","Kidney composite outcome (kidney disease populations)","Kidney failure; sustained eGFR decline of at least 50 percent; or kidney death","time_to_event","log_hazard","lower_better","critical","no","no","absolute","10","per 1000","156","Same components as O22. A composite that includes cardiovascular death is O22D. A doubling of serum creatinine composite without cardiovascular death is O22C."],["O51","P08A;P08B;P01","eGFR total slope","Annual change in eGFR from baseline (total slope; decline is negative)","continuous","MD","higher_better","important","no","no","absolute","0.75","mL/min/1.73 m2 per year",null,null],["O60","P09","Resolution of steatohepatitis without worsening of fibrosis","Histological resolution of MASH with no worsening of fibrosis","binary","log_odds","higher_better","critical","no","no","absolute","50","per 1000",null,null],["O61","P09","Fibrosis improvement without worsening of steatohepatitis","Improvement of at least one fibrosis stage with no worsening of MASH","binary","log_odds","higher_better","critical","no","no","absolute","50","per 1000",null,null],["O70","P10","Apnea hypopnea index change","Change in apnea hypopnea index (events per hour)","continuous","MD","lower_better","critical","no","no","absolute","5","events per hour",null,null],["O80","P11","WOMAC pain change","Change in WOMAC pain score rescaled to 0 to 100","continuous","MD","lower_better","critical","no","no","absolute","10","points (0 to 100)",null,"Scores on 0 to 20 or 0 to 50 scales are rescaled to 0 to 100 before pooling."],["O90A","P12","Ovulation","Ovulation as defined by the trial","binary","log_odds","higher_better","critical","no","no","absolute","50","per 1000",null,null],["O90B","P12","Regular menstrual cycles","Regular menses as defined by the trial","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,"Never pooled with O90A."],["O90C","P12","Live birth","Live birth per randomized participant","binary","log_odds","higher_better","critical","no","no","absolute","50","per 1000",null,null],["O100A","P13A","CDR-SB change","Change in Clinical Dementia Rating Sum of Boxes","continuous","MD","lower_better","critical","no","no","absolute","1","points",null,null],["O100B","P13A","ADAS-Cog change","Change in ADAS-Cog (13 item preferred)","continuous","MD","lower_better","important","no","no","absolute","3","points",null,"Never pooled with O100A."],["O101","P13B","Motor function (Parkinson disease)","Change in MDS-UPDRS part III in the off medication state","continuous","MD","lower_better","critical","no","no","absolute","3","points",null,null],["O110A","P14A","Heavy drinking days","Heavy drinking days per month","continuous","MD","lower_better","critical","no","no","absolute","2","days per month",null,null],["O110B","P14A","Alcohol abstinence","Complete self reported abstinence from alcohol during the final 4 weeks of treatment","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,"Other abstinence definitions are described and not pooled."],["O111","P14B","Tobacco abstinence","Biochemically verified continuous abstinence from the target quit date to the end of treatment","binary","log_odds","higher_better","critical","no","no","absolute","50","per 1000",null,"Point prevalence abstinence is O111B and never pooled with O111."],["O111B","P14B","Tobacco point prevalence abstinence","Biochemically verified 7 day point prevalence abstinence at the end of treatment","binary","log_odds","higher_better","important","no","no","absolute","50","per 1000",null,"Never pooled with O111."],["O112","P14C","Return to opioid use","Return to opioid use as defined by the trial","binary","log_odds","lower_better","critical","no","no","absolute","50","per 1000",null,null],["O113","P14D","Stimulant negative urine tests","Proportion with stimulant negative urine tests at the end of treatment","binary","log_odds","higher_better","critical","no","no","absolute","50","per 1000",null,null],["O114","P14E","Cannabis use days","Cannabis use days per month","continuous","MD","lower_better","critical","no","no","absolute","2","days per month",null,null],["O120","All","Major congenital malformations","Major congenital malformations after exposure in the periconception period or first trimester","binary","log_odds","lower_better","critical","yes","no","absolute","5","per 1000 pregnancies",null,"Nonrandomized evidence only; risk per pregnancy."],["O121","All","Acute kidney injury","Acute kidney injury","binary","log_hazard_cloglog","lower_better","important","yes","no","absolute","5","per 1000","52",null]]}