R Under development (unstable) (2025-11-11 r89006 ucrt) -- "Unsuffered Consequences" Copyright (C) 2025 The R Foundation for Statistical Computing Platform: x86_64-w64-mingw32/x64 R is free software and comes with ABSOLUTELY NO WARRANTY. You are welcome to redistribute it under certain conditions. Type 'license()' or 'licence()' for distribution details. R is a collaborative project with many contributors. Type 'contributors()' for more information and 'citation()' on how to cite R or R packages in publications. Type 'demo()' for some demos, 'help()' for on-line help, or 'help.start()' for an HTML browser interface to help. Type 'q()' to quit R. > # This file is part of the standard setup for testthat. > # It is recommended that you do not modify it. > # > # Where should you do additional test configuration? > # Learn more about the roles of various files in: > # * https://r-pkgs.org/testing-design.html#sec-tests-files-overview > # * https://testthat.r-lib.org/articles/special-files.html > > library(testthat) > library(rwevidence) > > test_check("rwevidence") [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.491 Mean PS (control): 0.48 [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:12] [INFO] [rwe_iptw] Starting IPTW analysis Calculating inverse probability weights... Using stabilized weights... Assessing weighted covariate balance... IPTW analysis complete! Mean weight (treated): 1 Mean weight (control): 1 Balance improvement: 98.5 % [2025-11-12 04:06:12] [INFO] [rwe_iptw] IPTW analysis complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: iptw [2025-11-12 04:06:12] [INFO] [rwe_iptw] Starting IPTW analysis Estimating propensity scores for IPTW... [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.545 Mean PS (control): 0.534 [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Calculating inverse probability weights... Using stabilized weights... Assessing weighted covariate balance... IPTW analysis complete! Mean weight (treated): 0.998 Mean weight (control): 1.002 Balance improvement: 96.1 % [2025-11-12 04:06:12] [INFO] [rwe_iptw] IPTW analysis complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: iptw [2025-11-12 04:06:12] [INFO] [rwe_iptw] Starting IPTW analysis [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 1 Mean PS (control): 0 [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:12] [INFO] [rwe_iptw] Starting IPTW analysis [2025-11-12 04:06:12] [INFO] [rwe_iptw] Starting IPTW analysis Estimating propensity scores for IPTW... [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.5 Mean PS (control): 0.5 [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Calculating inverse probability weights... Using stabilized weights... Assessing weighted covariate balance... IPTW analysis complete! Mean weight (treated): 1 Mean weight (control): 1 Balance improvement: 100 % [2025-11-12 04:06:12] [INFO] [rwe_iptw] IPTW analysis complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: iptw [2025-11-12 04:06:12] [INFO] [rwe_doubly_robust] Starting doubly robust estimation Doubly Robust Estimation ================================================== Step 1: Estimating propensity scores... [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.546 Mean PS (control): 0.544 [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Step 2: Fitting outcome regression models... Outcome models fitted successfully Step 3: Calculating doubly robust estimates... Doubly Robust Treatment Effect: ATE: 15.6187 SE: 1.3494 95% CI: ( 12.9738 , 18.2636 ) P-value: < 2.2e-16 [2025-11-12 04:06:12] [INFO] [rwe_doubly_robust] Doubly robust estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: doubly_robust_estimation [2025-11-12 04:06:12] [INFO] [rwe_doubly_robust] Starting doubly robust estimation Doubly Robust Estimation ================================================== Step 1: Estimating propensity scores... [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.451 Mean PS (control): 0.457 [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Step 2: Fitting outcome regression models... Outcome models fitted successfully Step 3: Calculating doubly robust estimates... Doubly Robust Treatment Effect: ATE: -3.0971 SE: 3.1625 95% CI: ( -9.2956 , 3.1014 ) P-value: 0.3274 [2025-11-12 04:06:12] [INFO] [rwe_doubly_robust] Doubly robust estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: doubly_robust_estimation [2025-11-12 04:06:12] [INFO] [rwe_doubly_robust] Starting doubly robust estimation Doubly Robust Estimation ================================================== Step 1: Estimating propensity scores... [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.485 Mean PS (control): 0.457 [2025-11-12 04:06:12] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Step 2: Fitting outcome regression models... Outcome models fitted successfully Step 3: Calculating doubly robust estimates... Doubly Robust Treatment Effect: ATE: -1.1094 SE: 3.7389 95% CI: ( -8.4376 , 6.2189 ) P-value: 0.7667 [2025-11-12 04:06:12] [INFO] [rwe_doubly_robust] Doubly robust estimation complete [2025-11-12 04:06:12] [INFO] [audit_trail] Audit trail created for operation: doubly_robust_estimation [2025-11-12 04:06:13] [INFO] [rwe_iptw] Starting IPTW analysis Estimating propensity scores for IPTW... [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.485 Mean PS (control): 0.457 [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Calculating inverse probability weights... Using stabilized weights... Assessing weighted covariate balance... IPTW analysis complete! Mean weight (treated): 1 Mean weight (control): 1 Balance improvement: 98.9 % [2025-11-12 04:06:13] [INFO] [rwe_iptw] IPTW analysis complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: iptw [2025-11-12 04:06:13] [INFO] [rwe_doubly_robust] Starting doubly robust estimation Doubly Robust Estimation ================================================== Step 1: Estimating propensity scores... [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.485 Mean PS (control): 0.457 [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Step 2: Fitting outcome regression models... Outcome models fitted successfully Step 3: Calculating doubly robust estimates... Doubly Robust Treatment Effect: ATE: -1.1094 SE: 3.7389 95% CI: ( -8.4376 , 6.2189 ) P-value: 0.7667 [2025-11-12 04:06:13] [INFO] [rwe_doubly_robust] Doubly robust estimation complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: doubly_robust_estimation [2025-11-12 04:06:13] [INFO] [rwe_iptw] Starting IPTW analysis Estimating propensity scores for IPTW... [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.5 Mean PS (control): 0.5 [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Calculating inverse probability weights... Using stabilized weights... Assessing weighted covariate balance... IPTW analysis complete! Mean weight (treated): 1 Mean weight (control): 1 Balance improvement: 100 % [2025-11-12 04:06:13] [INFO] [rwe_iptw] IPTW analysis complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: iptw [2025-11-12 04:06:13] [INFO] [rwe_doubly_robust] Starting doubly robust estimation Doubly Robust Estimation ================================================== Step 1: Estimating propensity scores... [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.5 Mean PS (control): 0.5 [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Step 2: Fitting outcome regression models... Outcome models fitted successfully Step 3: Calculating doubly robust estimates... Doubly Robust Treatment Effect: ATE: 6.2513 SE: 4.6271 95% CI: ( -2.8177 , 15.3204 ) P-value: 0.1767 [2025-11-12 04:06:13] [INFO] [rwe_doubly_robust] Doubly robust estimation complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: doubly_robust_estimation [2025-11-12 04:06:13] [INFO] [rwe_iptw] Starting IPTW analysis Estimating propensity scores for IPTW... [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.459 Mean PS (control): 0.492 [2025-11-12 04:06:13] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Calculating inverse probability weights... Using stabilized weights... Assessing weighted covariate balance... IPTW analysis complete! Mean weight (treated): 1.002 Mean weight (control): 0.997 Balance improvement: 96.3 % [2025-11-12 04:06:13] [INFO] [rwe_iptw] IPTW analysis complete [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: iptw [2025-11-12 04:06:13] [INFO] [rwe_relative_risk] Calculating relative risk [2025-11-12 04:06:13] [INFO] [rwe_relative_risk] Relative risk calculated [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: relative_risk_calculation [2025-11-12 04:06:13] [INFO] [rwe_odds_ratio] Calculating odds ratio [2025-11-12 04:06:13] [INFO] [rwe_odds_ratio] Odds ratio calculated [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: odds_ratio_calculation [2025-11-12 04:06:13] [INFO] [rwe_nnt] Calculating NNT/NNH [2025-11-12 04:06:13] [INFO] [rwe_nnt] NNT/NNH calculated [2025-11-12 04:06:13] [INFO] [audit_trail] Audit trail created for operation: nnt_calculation [2025-11-12 04:06:14] [INFO] [audit_trail] Audit trail created for operation: subgroup_effectiveness [2025-11-12 04:06:14] [INFO] [audit_trail] Audit trail created for operation: sensitivity_analysis [2025-11-12 04:06:14] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:14] [INFO] [rwe_read_ehr] EHR data loaded successfully. 10 records [2025-11-12 04:06:14] [INFO] [audit_trail] Audit trail created for operation: read_ehr [2025-11-12 04:06:14] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:14] [ERROR] [rwe_read_ehr] Failed to load data: File not found: non_existent_file.csv [2025-11-12 04:06:14] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:14] [INFO] [rwe_read_ehr] Applying date range filter [2025-11-12 04:06:14] [INFO] [filter_by_date] Filtered from 100 to 29 records [2025-11-12 04:06:14] [INFO] [rwe_read_ehr] EHR data loaded successfully. 29 records [2025-11-12 04:06:14] [INFO] [audit_trail] Audit trail created for operation: read_ehr [2025-11-12 04:06:14] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:14] [INFO] [rwe_read_ehr] EHR data loaded successfully. 5 records [2025-11-12 04:06:14] [INFO] [audit_trail] Audit trail created for operation: read_ehr [2025-11-12 04:06:15] [INFO] [filter_by_date] Filtered from 10 to 4 records [2025-11-12 04:06:15] [INFO] [rwe_read_claims] Reading claims data [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Validating EHR schema [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Schema validation passed [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] EHR data loaded successfully. 5 records [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: read_ehr [2025-11-12 04:06:15] [INFO] [rwe_read_registry] Reading registry data: SEER [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Validating EHR schema [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Schema validation passed [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] EHR data loaded successfully. 5 records [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: read_ehr [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] EHR data loaded successfully. 5 records [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: read_ehr [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] EHR data loaded successfully. 10 records [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: read_ehr [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] Starting EHR data load [2025-11-12 04:06:15] [INFO] [rwe_read_ehr] EHR data loaded successfully. 3 records [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: read_ehr [2025-11-12 04:06:15] [INFO] [rwe_map_terminology] Mapping terminology from icd10cm to snomed [2025-11-12 04:06:15] [INFO] [rwe_map_terminology] Mapped 2 of 3 codes [2025-11-12 04:06:15] [INFO] [rwe_map_terminology] Mapping terminology from NDC to RxNorm [2025-11-12 04:06:15] [INFO] [rwe_map_terminology] Mapped 2 of 2 codes [2025-11-12 04:06:15] [INFO] [rwe_map_terminology] Mapping terminology from ICD10CM to SNOMED [2025-11-12 04:06:15] [INFO] [rwe_map_terminology] Mapped 2 of 3 codes Join complete: 3 + 3 rows -> 3 rows (left join) [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 100 Auto-detected 2 variables with missing data Total missing values: 25 Using 2 predictor variables Imputing missing values... Imputation complete! Values imputed: 25 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: median Starting data imputation... Method: median Records: 100 Total missing values: 12 Using 2 predictor variables Imputing missing values... Imputation complete! Values imputed: 12 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mode Starting data imputation... Method: mode Records: 100 Total missing values: 15 Using 2 predictor variables Imputing missing values... Imputation complete! Values imputed: 15 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 50 Auto-detected 3 variables with missing data Total missing values: 16 Using 1 predictor variables Imputing missing values... Imputation complete! Values imputed: 16 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 50 Auto-detected 0 variables with missing data [2025-11-12 04:06:15] [INFO] [rwe_impute] No missing data found No missing data to impute! [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 100 Auto-detected 1 variables with missing data Total missing values: 20 Using 1 predictor variables Imputing missing values... Imputation complete! Values imputed: 20 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 100 Auto-detected 1 variables with missing data Total missing values: 20 Using 1 predictor variables Imputing missing values... Imputation complete! Values imputed: 20 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 100 Auto-detected 1 variables with missing data Total missing values: 20 Using 1 predictor variables Imputing missing values... Imputation complete! Values imputed: 20 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 100 Auto-detected 2 variables with missing data Total missing values: 25 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 25 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 6 Auto-detected 2 variables with missing data Total missing values: 4 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 4 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 4 Auto-detected 2 variables with missing data Total missing values: 2 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 2 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 5 Auto-detected 2 variables with missing data Total missing values: 3 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 3 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 4 Total missing values: 4 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 4 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:15] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 10 Total missing values: 6 Using 1 predictor variables Imputing missing values... Imputation complete! Values imputed: 6 [2025-11-12 04:06:15] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:15] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:16] [WARNING] [impute_mean] Skipping non-numeric variable: char_var [2025-11-12 04:06:16] [WARNING] [impute_median] Skipping non-numeric variable: char_var [2025-11-12 04:06:16] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 6 Auto-detected 2 variables with missing data Total missing values: 4 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 4 [2025-11-12 04:06:16] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:16] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:16] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 4 Auto-detected 1 variables with missing data Total missing values: 1 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 1 [2025-11-12 04:06:16] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:16] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:16] [INFO] [rwe_impute] Starting imputation with method: median Starting data imputation... Method: median Records: 4 Auto-detected 1 variables with missing data Total missing values: 1 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 1 [2025-11-12 04:06:16] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:16] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:16] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 4 Total missing values: 4 Using 1 predictor variables Imputing missing values... [2025-11-12 04:06:16] [WARNING] [impute_mean] Skipping non-numeric variable: age Imputation complete! Values imputed: 0 [2025-11-12 04:06:16] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:16] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:16] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 1 Auto-detected 1 variables with missing data Total missing values: 1 Using 1 predictor variables Imputing missing values... [2025-11-12 04:06:16] [WARNING] [impute_mean] Skipping non-numeric variable: age Imputation complete! Values imputed: 0 [2025-11-12 04:06:16] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:16] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:16] [INFO] [rwe_impute] Starting imputation with method: knn Starting data imputation... Method: knn Records: 150 Total missing values: 20 Using 2 predictor variables Imputing missing values... Imputation complete! Values imputed: 20 [2025-11-12 04:06:16] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:16] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:17] [INFO] [rwe_impute] Starting imputation with method: xgboost Starting data imputation... Method: xgboost Records: 120 Total missing values: 18 Using 2 predictor variables Imputing missing values... Imputation complete! Values imputed: 18 [2025-11-12 04:06:17] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:17] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:17] [INFO] [rwe_impute] Starting imputation with method: mean Starting data imputation... Method: mean Records: 4 Auto-detected 1 variables with missing data Total missing values: 1 Using 0 predictor variables Imputing missing values... Imputation complete! Values imputed: 1 [2025-11-12 04:06:17] [INFO] [rwe_impute] Imputation complete [2025-11-12 04:06:17] [INFO] [audit_trail] Audit trail created for operation: imputation [2025-11-12 04:06:17] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 4 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.488 Mean PS (control): 0.482 [2025-11-12 04:06:17] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:17] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:17] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: xgboost Treatment: treatment Covariates: 3 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.361 Mean PS (control): 0.665 [2025-11-12 04:06:17] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:17] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: super_learner Treatment: treatment Covariates: 3 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.46 Mean PS (control): 0.442 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.545 Mean PS (control): 0.534 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.416 Mean PS (control): 0.471 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.491 Mean PS (control): 0.48 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_match] Performing nearest matching Performing propensity score matching... Method: nearest Ratio: 1 :1 Caliper: 0.1 Matching cohorts... [2025-11-12 04:06:18] [INFO] [perform_simple_matching] Using MatchIt package for matching [2025-11-12 04:06:18] [INFO] [perform_simple_matching] Matched 194 observations Assessing post-matching balance... Matching complete! Matched pairs: 200 Balance improvement: 0 % [2025-11-12 04:06:18] [INFO] [rwe_match] Matching complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_matching [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.541 Mean PS (control): 0.538 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.425 Mean PS (control): 0.531 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_match] Performing nearest matching Performing propensity score matching... Method: nearest Ratio: 1 :1 Caliper: 0.1 Matching cohorts... [2025-11-12 04:06:18] [INFO] [perform_simple_matching] Using MatchIt package for matching [2025-11-12 04:06:18] [INFO] [perform_simple_matching] Matched 162 observations Assessing post-matching balance... Matching complete! Matched pairs: 200 Balance improvement: 0 % [2025-11-12 04:06:18] [INFO] [rwe_match] Matching complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_matching [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.485 Mean PS (control): 0.457 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.485 Mean PS (control): 0.457 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_match] Performing nearest matching Performing propensity score matching... Method: nearest Ratio: 1 :1 Caliper: 0.1 Matching cohorts... [2025-11-12 04:06:18] [INFO] [perform_simple_matching] Using MatchIt package for matching [2025-11-12 04:06:18] [INFO] [perform_simple_matching] Matched 94 observations Assessing post-matching balance... Matching complete! Matched pairs: 100 Balance improvement: 0 % [2025-11-12 04:06:18] [INFO] [rwe_match] Matching complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_matching [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Removing 6 observations with missing data... Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.483 Mean PS (control): 0.455 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [perform_simple_matching] Using MatchIt package for matching [2025-11-12 04:06:18] [INFO] [perform_simple_matching] Matched 62 observations [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 2 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.485 Mean PS (control): 0.456 [2025-11-12 04:06:18] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 4 Continuous: 2 Categorical: 2 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 4 Continuous: 2 Categorical: 2 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 2 Categorical: 0 Processing continuous variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 0 Categorical: 2 Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation Table 1 exported to: D:\temp\2025_11_12_04_05_16_32623\Rtmpaekkhl\fileb3e0796f12ab.html [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation Table 1 exported to: D:\temp\2025_11_12_04_05_16_32623\Rtmpaekkhl\fileb3e01f083b01.csv [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Excluded: 150 - Did not meet criteria : 100 - Declined : 50 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 FOLLOW-UP Treatment : Lost to follow-up: 5 Completed follow-up: 170 Control : Lost to follow-up: 10 Completed follow-up: 165 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 FOLLOW-UP Treatment : Discontinued: 5 - Adverse events : 3 - Withdrew : 2 Completed follow-up: 170 Control : Discontinued: 5 - Adverse events : 1 - Withdrew : 4 Completed follow-up: 170 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 400 ALLOCATION Treatment : 200 Control : 200 ANALYSIS Treatment analyzed: 180 Control analyzed: 190 Total analyzed: 370 RETENTION RATES Treatment : 90 % Control : 95 % Overall Attrition: 7.5 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 400 ALLOCATION Treatment : 200 Control : 200 ANALYSIS Treatment analyzed: 180 Control analyzed: 160 Total analyzed: 340 RETENTION RATES Treatment : 90 % Control : 80 % Overall Attrition: 15 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 3 SCREENING & ENROLLMENT Assessed for eligibility: 600 Enrolled: 450 ALLOCATION Treatment A : 150 Treatment B : 150 Control : 150 ANALYSIS Treatment A analyzed: 140 Treatment B analyzed: 135 Control analyzed: 145 Total analyzed: 420 RETENTION RATES Treatment A : 93.3 % Treatment B : 90 % Control : 96.7 % Overall Attrition: 6.7 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Excluded: 150 - Did not meet criteria : 150 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 FOLLOW-UP Treatment : Lost to follow-up: 5 Completed follow-up: 170 Control : Lost to follow-up: 10 Completed follow-up: 165 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: cohort Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: external_control Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:18] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: A, B, C Variables: 2 Continuous: 2 Categorical: 0 Processing continuous variables... Table 1 creation complete! [2025-11-12 04:06:18] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 Safety report created successfully! [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 SERIOUS ADVERSE EVENTS Treatment : 12 SAEs ( 10 %) Control : 22 SAEs ( 12.2 %) Safety report created successfully! [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 ADVERSE EVENTS BY SEVERITY Treatment : Mild : 75 Moderate : 32 Severe : 13 Control : Mild : 108 Moderate : 52 Severe : 20 Safety report created successfully! [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 OVERALL ADVERSE EVENT RATES Treatment : Patients: 50 Total AEs: 120 AEs per patient: 2.4 Control : Patients: 50 Total AEs: 180 AEs per patient: 3.6 Safety report created successfully! [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 Safety report created successfully! [2025-11-12 04:06:18] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:18] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 OVERALL ADVERSE EVENT RATES Treatment : Patients: 50 Total AEs: 120 AEs per patient: 2.4 Control : Patients: 50 Total AEs: 180 AEs per patient: 3.6 SERIOUS ADVERSE EVENTS Treatment : 12 SAEs ( 24 %) Control : 22 SAEs ( 44 %) ADVERSE EVENTS BY SEVERITY Treatment : Mild : 75 Moderate : 32 Severe : 13 Control : Mild : 108 Moderate : 52 Severe : 20 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: B, A, C Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES B : Patients: 100 Total AEs: 100 AEs per patient: 1 A : Patients: 97 Total AEs: 97 AEs per patient: 1 C : Patients: 103 Total AEs: 103 AEs per patient: 1 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:19] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:19] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 350 ALLOCATION Treatment : 175 Control : 175 ANALYSIS Treatment analyzed: 165 Control analyzed: 160 Total analyzed: 325 RETENTION RATES Treatment : 94.3 % Control : 91.4 % Overall Attrition: 7.1 % CONSORT diagram data created successfully! [2025-11-12 04:06:19] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Phase III Clinical Trial [x] Table 1 (Baseline Characteristics) included [x] CONSORT Diagram included [x] Safety Report included Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Test Study [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Test Study [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Test Study [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Test Study Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Test Study [x] Study Information included Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Test Study [x] Efficacy Results included Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Test Study Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Test Study Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:19] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Phase III Clinical Trial [x] Table 1 (Baseline Characteristics) included Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 2 Continuous: 1 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:19] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Export Test [x] Table 1 (Baseline Characteristics) included Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Treatment, Control Variables: 3 Continuous: 2 Categorical: 1 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:19] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:19] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Enrolled: 400 ALLOCATION Treatment : 200 Control : 200 ANALYSIS Treatment analyzed: 185 Control analyzed: 180 Total analyzed: 365 RETENTION RATES Treatment : 92.5 % Control : 90 % Overall Attrition: 8.8 % CONSORT diagram data created successfully! [2025-11-12 04:06:19] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Treatment, Control Total AE Records: 300 Note: Using observed counts as denominators OVERALL ADVERSE EVENT RATES Treatment : Patients: 120 Total AEs: 120 AEs per patient: 1 Control : Patients: 180 Total AEs: 180 AEs per patient: 1 SERIOUS ADVERSE EVENTS Treatment : 12 SAEs ( 10 %) Control : 22 SAEs ( 12.2 %) ADVERSE EVENTS BY SEVERITY Treatment : Mild : 75 Moderate : 32 Severe : 13 Control : Mild : 108 Moderate : 52 Severe : 20 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Creating comprehensive regulatory report Comprehensive Regulatory Report ================================================== Study: Efficacy and Safety Study [x] Table 1 (Baseline Characteristics) included [x] CONSORT Diagram included [x] Safety Report included [x] Efficacy Results included [x] Study Information included Report compiled successfully! [2025-11-12 04:06:19] [INFO] [rwe_regulatory_report] Regulatory report created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: regulatory_report_creation [2025-11-12 04:06:19] [INFO] [rwe_relative_risk] Calculating relative risk [2025-11-12 04:06:19] [INFO] [rwe_relative_risk] Relative risk calculated [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: relative_risk_calculation [2025-11-12 04:06:19] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ arm Estimating survival curves... Performing log-rank test... Chi-square: 0.207 P-value: 0.6495 Median Survival Times: median 0.95LCL 0.95UCL arm=Control 32.09935 22.95944 42.24115 arm=Drug 31.18992 15.77087 40.71114 [2025-11-12 04:06:19] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: subgroup_effectiveness [2025-11-12 04:06:19] [INFO] [rwe_analyze_safety] Starting comprehensive safety analysis [2025-11-12 04:06:19] [INFO] [rwe_incidence_rate] Calculating safety incidence rates [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: incidence_rate [2025-11-12 04:06:19] [INFO] [rwe_rate_ratio] Calculating incidence rate ratio [2025-11-12 04:06:19] [INFO] [rwe_incidence_rate] Calculating safety incidence rates [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: incidence_rate [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: rate_ratio [2025-11-12 04:06:19] [INFO] [rwe_safety_signal] Running safety signal surveillance [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_signal [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_analysis [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Control, Drug Total AE Records: 300 OVERALL ADVERSE EVENT RATES Control : Patients: 142 Total AEs: 142 AEs per patient: 1 Drug : Patients: 158 Total AEs: 158 AEs per patient: 1 SERIOUS ADVERSE EVENTS Control : 16 SAEs ( 11.3 %) Drug : 18 SAEs ( 11.4 %) ADVERSE EVENTS BY SEVERITY Control : Mild : 61 Moderate : 43 Severe : 38 Drug : Mild : 53 Moderate : 57 Severe : 48 Safety report created successfully! [2025-11-12 04:06:19] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:19] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 500 Excluded: 100 - Not eligible : 60 - Declined : 40 Enrolled: 400 ALLOCATION Drug : 200 Control : 200 FOLLOW-UP Drug : Lost to follow-up: 15 Discontinued: 8 - Adverse events : 8 Completed follow-up: 177 Control : Lost to follow-up: 12 Discontinued: 5 - Adverse events : 5 Completed follow-up: 183 ANALYSIS Drug analyzed: 177 Control analyzed: 183 Total analyzed: 360 RETENTION RATES Drug : 88.5 % Control : 91.5 % Overall Attrition: 10 % CONSORT diagram data created successfully! [2025-11-12 04:06:19] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:19] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: Drug, Control Variables: 4 Continuous: 2 Categorical: 2 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:19] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: results_table [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: results_table [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: results_table [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: results_table [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: automated_regulatory_report [2025-11-12 04:06:19] [INFO] [rwe_table_one] Creating Table 1 (baseline characteristics) Table 1: Baseline Characteristics ================================================== Groups: A, B Variables: 4 Continuous: 2 Categorical: 2 Processing continuous variables... Processing categorical variables... Table 1 creation complete! [2025-11-12 04:06:19] [INFO] [rwe_table_one] Table 1 created [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: table_one_creation [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: results_table [2025-11-12 04:06:19] [INFO] [rwe_relative_risk] Calculating relative risk [2025-11-12 04:06:19] [INFO] [rwe_relative_risk] Relative risk calculated [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: relative_risk_calculation [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: results_table [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: subgroup_effectiveness [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: results_table [2025-11-12 04:06:19] [INFO] [rwe_analyze_safety] Starting comprehensive safety analysis [2025-11-12 04:06:19] [INFO] [rwe_incidence_rate] Calculating safety incidence rates [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: incidence_rate [2025-11-12 04:06:19] [INFO] [rwe_rate_ratio] Calculating incidence rate ratio [2025-11-12 04:06:19] [INFO] [rwe_incidence_rate] Calculating safety incidence rates [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: incidence_rate [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: rate_ratio [2025-11-12 04:06:19] [INFO] [rwe_safety_signal] Running safety signal surveillance [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_signal [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: safety_analysis [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: results_table [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: subgroup_effectiveness [2025-11-12 04:06:19] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ treatment Estimating survival curves... Performing log-rank test... Chi-square: 0.098 P-value: 0.7544 Median Survival Times: median 0.95LCL 0.95UCL treatment=A 13.88848 11.59851 27.43457 treatment=B 13.88892 11.36440 20.00846 [2025-11-12 04:06:19] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:19] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [2025-11-12 04:06:20] [INFO] [rwe_safety_report] Creating safety report Safety Report: Adverse Events ================================================== Treatment Groups: Control, Drug Total AE Records: 160 OVERALL ADVERSE EVENT RATES Control : Patients: 73 Total AEs: 73 AEs per patient: 1 Drug : Patients: 87 Total AEs: 87 AEs per patient: 1 SERIOUS ADVERSE EVENTS Control : 11 SAEs ( 15.1 %) Drug : 6 SAEs ( 6.9 %) ADVERSE EVENTS BY SEVERITY Control : Mild : 24 Moderate : 24 Severe : 25 Drug : Mild : 33 Moderate : 34 Severe : 20 Safety report created successfully! [2025-11-12 04:06:20] [INFO] [rwe_safety_report] Safety report complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: safety_report_creation [2025-11-12 04:06:20] [INFO] [rwe_consort_diagram] Creating CONSORT flow diagram CONSORT Flow Diagram ================================================== Study Type: rct Number of Arms: 2 SCREENING & ENROLLMENT Assessed for eligibility: 1200 Excluded: 250 - Did not meet inclusion criteria : 200 - Declined to participate : 50 Enrolled: 900 ALLOCATION Treatment A : 450 Treatment B : 450 FOLLOW-UP Treatment A : Lost to follow-up: 30 Discontinued: 25 - Adverse events : 15 - Protocol deviation : 10 Completed follow-up: 395 Treatment B : Lost to follow-up: 25 Discontinued: 12 - Adverse events : 12 Completed follow-up: 413 ANALYSIS Treatment A analyzed: 395 Treatment B analyzed: 413 Total analyzed: 808 RETENTION RATES Treatment A : 87.8 % Treatment B : 91.8 % Overall Attrition: 10.2 % CONSORT diagram data created successfully! [2025-11-12 04:06:20] [INFO] [rwe_consort_diagram] CONSORT diagram created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: consort_diagram_creation [2025-11-12 04:06:20] [INFO] [rwe_incidence_rate] Calculating safety incidence rates [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: incidence_rate [2025-11-12 04:06:20] [INFO] [rwe_rate_ratio] Calculating incidence rate ratio [2025-11-12 04:06:20] [INFO] [rwe_incidence_rate] Calculating safety incidence rates [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: incidence_rate [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: rate_ratio [2025-11-12 04:06:20] [INFO] [rwe_safety_signal] Running safety signal surveillance [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: safety_signal [2025-11-12 04:06:20] [INFO] [rwe_analyze_safety] Starting comprehensive safety analysis [2025-11-12 04:06:20] [INFO] [rwe_incidence_rate] Calculating safety incidence rates [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: incidence_rate [2025-11-12 04:06:20] [INFO] [rwe_rate_ratio] Calculating incidence rate ratio [2025-11-12 04:06:20] [INFO] [rwe_incidence_rate] Calculating safety incidence rates [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: incidence_rate [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: rate_ratio [2025-11-12 04:06:20] [INFO] [rwe_safety_signal] Running safety signal surveillance [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: safety_signal [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: safety_analysis [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: exact Target ratio: 2 controls per treatment patient Performing matching... Matching complete! Matched controls: 100 Actual ratio: 2 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: nearest Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Applying inclusion criteria... age in [ 40 , 75 ]: 200 -> 184 disease_stage in I, II, III : 184 -> 150 Eligible controls after criteria: 150 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Applying exclusion criteria... Excluding prior_treatment : 200 -> 144 Eligible controls after criteria: 144 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Applying inclusion criteria... age in [ 40 , 75 ]: 200 -> 184 Applying exclusion criteria... Excluding prior_treatment : 184 -> 133 Eligible controls after criteria: 133 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: propensity Target ratio: 2 controls per treatment patient Performing matching... Matching complete! Matched controls: 100 Actual ratio: 2 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_external_control] Starting external control arm generation External Control Arm Generation ================================================== Initial Counts: External pool: 200 patients Treatment arm: 50 patients Eligible controls after criteria: 200 Matching method: propensity Target ratio: 1 controls per treatment patient Performing matching... Matching complete! Matched controls: 50 Actual ratio: 1 Assessing covariate balance... [2025-11-12 04:06:20] [INFO] [rwe_external_control] External control arm generation complete [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: external_control_generation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test RWE Study Study Type: external_control Protocol Version: 1.0 Population Definition: disease : Cancer age_range : 18 85 Primary Endpoint: Type: time_to_event Variable: overall_survival Timepoint: 365 days Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Type: cohort Protocol Version: 1.0 [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Type: cohort Protocol Version: 1.0 [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Inclusion Criteria: 2 criteria defined Primary Endpoint: Type: continuous Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Exclusion Criteria: 2 criteria defined Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: external_control Protocol Version: 1.0 Population Definition: disease : Cancer Treatment Definition: drug : Drug X route : oral min_exposure : 30 Primary Endpoint: Type: time_to_event Variable: survival Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: time_to_event Variable: survival Secondary Endpoints: 2 endpoints defined Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: external_control Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: time_to_event Variable: survival Propensity Score Variables: 4 variables age, sex, disease_stage, comorbidities Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: time_to_event Variable: survival Sensitivity Analyses: 3 analyses planned Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: time_to_event Variable: survival Subgroup Analyses: 3 subgroups planned Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 2.1 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: external_control Protocol Version: 1.0 Population Definition: disease : Cancer Inclusion Criteria: 1 criteria defined Exclusion Criteria: 1 criteria defined Treatment Definition: drug : Drug X Primary Endpoint: Type: time_to_event Variable: survival Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test cohort Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test case_control Study Study Type: case_control Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test external_control Study Study Type: external_control Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:20] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test registry Study Study Type: registry Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:20] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:20] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:21] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Inclusion Criteria: 1 criteria defined Exclusion Criteria: 1 criteria defined Primary Endpoint: Type: time_to_event Variable: survival Secondary Endpoints: 1 endpoints defined Propensity Score Variables: 2 variables age, sex Study design template created successfully! [2025-11-12 04:06:21] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:21] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:21] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:21] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:21] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:21] [INFO] [rwe_design_study] Creating study design template Real-World Evidence Study Design ================================================== Study Title: Test Study Study Type: cohort Protocol Version: 1.0 Population Definition: disease : Cancer Primary Endpoint: Type: binary Variable: response Study design template created successfully! [2025-11-12 04:06:21] [INFO] [rwe_design_study] Study design template created [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: study_design_creation [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Formula: ..surv.. ~ treatment + age Fitting Cox model... Treatment Effect: Hazard Ratio: 1.488 95% CI: ( 1.059 , 2.09 ) P-value: 0.02192 Model Statistics: N: 200 Events: 143 Concordance: 0.56 R-squared: 0.053 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event [2025-11-12 04:06:21] [INFO] [rwe_iptw] Starting IPTW analysis Estimating propensity scores for IPTW... [2025-11-12 04:06:21] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.533 Mean PS (control): 0.534 [2025-11-12 04:06:21] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Calculating inverse probability weights... Using stabilized weights... Assessing weighted covariate balance... IPTW analysis complete! Mean weight (treated): 1 Mean weight (control): 1 Balance improvement: 98.3 % [2025-11-12 04:06:21] [INFO] [rwe_iptw] IPTW analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: iptw [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Using IPTW weights Formula: ..surv.. ~ treatment Fitting Cox model... Treatment Effect: Hazard Ratio: 1.705 95% CI: ( 1.145 , 2.538 ) P-value: 0.008619 Model Statistics: N: 150 Events: 100 Concordance: 0.557 R-squared: 0.042 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Using IPTW weights Formula: ..surv.. ~ treatment Fitting Cox model... Treatment Effect: Hazard Ratio: 0.716 95% CI: ( 0.412 , 1.245 ) P-value: 0.2371 Model Statistics: N: 100 Events: 57 Concordance: 0.533 R-squared: 0.018 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Formula: ..surv.. ~ treatment + age + sex + bmi Fitting Cox model... Treatment Effect: Hazard Ratio: 0.76 95% CI: ( 0.503 , 1.149 ) P-value: 0.1929 Model Statistics: N: 150 Events: 98 Concordance: 0.599 R-squared: 0.032 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Formula: ..surv.. ~ treatment + age Fitting Cox model... Treatment Effect: Hazard Ratio: 1.198 95% CI: ( 0.556 , 2.583 ) P-value: 0.6441 Model Statistics: N: 50 Events: 28 Concordance: 0.531 R-squared: 0.008 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ treatment Estimating survival curves... Performing log-rank test... Chi-square: 1.188 P-value: 0.2758 Median Survival Times: median 0.95LCL 0.95UCL treatment=0 10.814852 6.988417 14.63301 treatment=1 9.658712 7.314796 12.79486 [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ 1 Estimating survival curves... Median Survival Times: Median: 8.562329 95% CI: ( 6.363885 , 12.52739 ) [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis [2025-11-12 04:06:21] [INFO] [rwe_iptw] Starting IPTW analysis Estimating propensity scores for IPTW... [2025-11-12 04:06:21] [INFO] [rwe_propensity_score] Estimating propensity scores Estimating propensity scores... Method: logistic Treatment: treatment Covariates: 1 Calculating baseline covariate balance... Fitting propensity score model... Propensity score estimation complete! Mean PS (treated): 0.551 Mean PS (control): 0.556 [2025-11-12 04:06:21] [INFO] [rwe_propensity_score] Propensity score estimation complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: propensity_score_estimation Calculating inverse probability weights... Using stabilized weights... Assessing weighted covariate balance... IPTW analysis complete! Mean weight (treated): 1 Mean weight (control): 1 Balance improvement: 98.5 % [2025-11-12 04:06:21] [INFO] [rwe_iptw] IPTW analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: iptw [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ treatment Estimating survival curves... Performing log-rank test... [2025-11-12 04:06:21] [WARNING] [rwe_kaplan_meier] Log-rank test failed: unused argument (weights = weights_vec) Median Survival Times: median 0.95LCL 0.95UCL treatment=0 10.13510 6.966522 14.459702 treatment=1 7.66481 4.798583 9.949547 [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ treatment Estimating survival curves... Performing log-rank test... Chi-square: 0.189 P-value: 0.6634 Median Survival Times: median 0.95LCL 0.95UCL treatment=0 13.29055 8.431497 NA treatment=1 12.29026 7.906818 NA [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Formula: ..surv.. ~ treatment + age Fitting Cox model... Treatment Effect: Hazard Ratio: 1.046 95% CI: ( 0.617 , 1.771 ) P-value: 0.8681 Model Statistics: N: 100 Events: 59 Concordance: 0.512 R-squared: 0.032 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ treatment Estimating survival curves... Performing log-rank test... Chi-square: 0.001 P-value: 0.9806 Median Survival Times: median 0.95LCL 0.95UCL treatment=0 12.54641 10.244413 18.56922 treatment=1 11.68529 6.854586 NA [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Formula: ..surv.. ~ treatment + age Fitting Cox model... Treatment Effect: Hazard Ratio: 1.198 95% CI: ( 0.556 , 2.583 ) P-value: 0.6441 Model Statistics: N: 50 Events: 28 Concordance: 0.531 R-squared: 0.008 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ treatment Estimating survival curves... Performing log-rank test... Chi-square: 2.128 P-value: 0.1446 Median Survival Times: median 0.95LCL 0.95UCL treatment=0 NA 8.352550 NA treatment=1 7.984485 6.862345 NA [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Formula: ..surv.. ~ treatment + age Fitting Cox model... Treatment Effect: Hazard Ratio: 0.674 95% CI: ( 0.393 , 1.157 ) P-value: 0.1524 Model Statistics: N: 100 Events: 57 Concordance: 0.552 R-squared: 0.023 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Formula: ..surv.. ~ treatment + age Fitting Cox model... Treatment Effect: Hazard Ratio: 1.359 95% CI: ( 0.792 , 2.33 ) P-value: 0.2653 Model Statistics: N: 100 Events: 55 Concordance: 0.565 R-squared: 0.016 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Starting Cox regression analysis Cox Proportional Hazards Regression ================================================== Time variable: time Event variable: event Treatment variable: treatment Formula: ..surv.. ~ treatment + age Fitting Cox model... Treatment Effect: Hazard Ratio: 1.046 95% CI: ( 0.617 , 1.771 ) P-value: 0.8681 Model Statistics: N: 100 Events: 59 Concordance: 0.512 R-squared: 0.032 [2025-11-12 04:06:21] [INFO] [rwe_cox_regression] Cox regression complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: cox_regression [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Starting Kaplan-Meier analysis Kaplan-Meier Survival Analysis ================================================== Formula: ..surv.. ~ treatment Estimating survival curves... Performing log-rank test... Chi-square: 0.001 P-value: 0.9806 Median Survival Times: median 0.95LCL 0.95UCL treatment=0 12.54641 10.244413 18.56922 treatment=1 11.68529 6.854586 NA [2025-11-12 04:06:21] [INFO] [rwe_kaplan_meier] Kaplan-Meier analysis complete [2025-11-12 04:06:21] [INFO] [audit_trail] Audit trail created for operation: kaplan_meier [ FAIL 0 | WARN 27 | SKIP 6 | PASS 658 ] ══ Skipped tests (6) ═══════════════════════════════════════════════════════════ • ATE estimation tests temporarily disabled - needs further debugging (1): 'test-causal_inference.R:101:3' • ATE print test temporarily disabled - needs further debugging (1): 'test-causal_inference.R:256:3' • Binary outcome tests temporarily disabled due to convergence issues (2): 'test-causal_inference.R:354:3', 'test-causal_inference.R:359:3' • Stabilized weights test temporarily disabled - needs PS trimming fix (1): 'test-causal_inference.R:64:3' • Weight truncation test temporarily disabled - needs PS trimming fix (1): 'test-causal_inference.R:69:3' [ FAIL 0 | WARN 27 | SKIP 6 | PASS 658 ] > > proc.time() user system elapsed 8.21 1.59 9.76