HF-1002-CL-101 ADaM analysis datasets for HF-1002-CL-101 HF-1002-CL-101 Subject-Level Analysis Dataset adsl.xpt Adverse Events Analysis Dataset adae.xpt Exposure Analysis Dataset adex.xpt Laboratory Analysis Dataset adlb.xpt Vital Signs Analysis Dataset advs.xpt Imaging Analysis Dataset adimg.xpt Efficacy Analysis Dataset adeff.xpt Study Identifier Unique Subject Identifier Subject Identifier for the Study Study Site Identifier Description of Planned Arm Planned Arm Code Description of Actual Arm Actual Arm Code Cohort Dose Level (vg) Planned Treatment for Period 01 Planned Treatment for Period 01 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Age Pooled Age Group 1 Pooled Age Group 1 (N) Sex Race Ethnicity Country Baseline Height (cm) Baseline Weight (kg) Baseline BMI (kg/m2) Date of First Exposure to Treatment Date of Last Exposure to Treatment Total Treatment Duration (Days) End of Study Date Total Time on Study (Days) Date of Death Subject Death Flag End of Study Status Reason for Discontinuation from Study Enrolled Population Flag Safety Population Flag Full Analysis Set Population Flag DLT-Evaluable Population Flag Study Identifier Unique Subject Identifier Subject Identifier for the Study Study Site Identifier Actual Treatment Actual Treatment (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Cohort Age Pooled Age Group 1 Sex Race Safety Population Flag Sequence Number Reported Term for the Adverse Event Dictionary-Derived Term Body System or Organ Class Analysis Start Date Analysis End Date Analysis Start Relative Day Analysis End Relative Day Analysis Duration (N) Analysis Toxicity Grade Serious Event Analysis Causality Outcome of Adverse Event Action Taken with Study Treatment Treatment Emergent Analysis Flag 1st Occurrence of Any AE Flag 1st Occurrence of Preferred Term Flag Dose-Limiting Toxicity Flag Study Identifier Unique Subject Identifier Subject Identifier for the Study Study Site Identifier Planned Treatment for Period 01 Planned Treatment for Period 01 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Cohort Safety Population Flag Parameter Code Parameter Parameter (N) Analysis Value Analysis Value Unit Study Identifier Unique Subject Identifier Subject Identifier for the Study Study Site Identifier Planned Treatment for Period 01 Planned Treatment for Period 01 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Cohort Age Pooled Age Group 1 Pooled Age Group 1 (N) Sex Race Ethnicity Safety Population Flag Full Analysis Set Population Flag Parameter Code Parameter Parameter (N) Parameter Category 1 Analysis Visit Analysis Visit (N) Analysis Date Analysis Relative Day Analysis Value Analysis Value (C) Baseline Value Change from Baseline Percent Change from Baseline Baseline Record Flag Analysis Record Flag 01 Analysis Normal Range Lower Limit Analysis Normal Range Upper Limit Analysis Reference Range Indicator Baseline Reference Range Indicator Study Identifier Unique Subject Identifier Subject Identifier for the Study Study Site Identifier Planned Treatment for Period 01 Planned Treatment for Period 01 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Cohort Age Pooled Age Group 1 Pooled Age Group 1 (N) Sex Race Ethnicity Safety Population Flag Full Analysis Set Population Flag Parameter Code Parameter Parameter (N) Parameter Category 1 Analysis Visit Analysis Visit (N) Analysis Date Analysis Relative Day Analysis Value Analysis Value (C) Baseline Value Change from Baseline Percent Change from Baseline Baseline Record Flag Analysis Record Flag 01 Study Identifier Unique Subject Identifier Subject Identifier for the Study Study Site Identifier Planned Treatment for Period 01 Planned Treatment for Period 01 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Cohort Age Pooled Age Group 1 Pooled Age Group 1 (N) Sex Race Ethnicity Safety Population Flag Full Analysis Set Population Flag Parameter Code Parameter Parameter (N) Parameter Category 1 Analysis Visit Analysis Visit (N) Analysis Date Analysis Relative Day Analysis Value Analysis Value (C) Baseline Value Change from Baseline Percent Change from Baseline Baseline Record Flag Analysis Record Flag 01 Study Identifier Unique Subject Identifier Subject Identifier for the Study Study Site Identifier Planned Treatment for Period 01 Planned Treatment for Period 01 (N) Actual Treatment for Period 01 Actual Treatment for Period 01 (N) Cohort Age Pooled Age Group 1 Pooled Age Group 1 (N) Sex Race Ethnicity Safety Population Flag Full Analysis Set Population Flag Parameter Code Parameter Parameter (N) Parameter Category 1 Analysis Visit Analysis Visit (N) Analysis Date Analysis Relative Day Analysis Value Analysis Value (C) Baseline Value Change from Baseline Percent Change from Baseline Baseline Record Flag Analysis Record Flag 01 No Yes Yes Male Female < 65 years >= 65 years Completed Discontinued Ongoing