ClinTrialStat eCRF Builder Created ODM Domains ClinTrialStat eCRF Builder Created ODM Domains ClinTrialStat eCRF Builder Created ODM Domains Demographics Study Medication Exposure Medical History Disease Status at baseline Adverse Events Concomitant Medications Vital Signs Physical Exam Change from Baseline Disease Status Disposition 1=Male 2=Female 1=Caucasian 2=Black 3=Asian 4=Hispanic 5=Other 1=Lack Medical Records 2=Subject Cannot Recall 3=Other 1=Very Poor 2=Poor 3=Fair 4=Good 5=Very Good 1=HHMM5. 1=Mild 2=Moderate 3=Severe 1=None 2=Reduce dose of study drug 3=Temperate stop study drug 4=Permanente stop study drug 5=Other 1=Not related 2=Possible 3=Probable 4=Very likely 1=Resolved 2=Peresisting 3=Uuknown 1=Permanent 2=Serious 3=Disable 4=Incapacitating 5=Other 1=Normal 2=Abnormal - Mild 3=Abnormal - Moderate 4=Abnormal - Severe 1=Much Worse 2=Worse 3=No Change 4=A Little Bit Better 5=Better 6=Much Better 1=Adverse Event 2=Lost Follow-up 3=Patient Withrawal 4=Lack of Efficacy 5=Death 6=Other