CDISC01 CDISC01 Test Study. CDISC01 Annotated Case Report Form QTcB = QT interval / square root of (60 / heart rate) QTcF = QT interval / cubic root of (60 / heart rate) sv.xpt ta.xpt te.xpt ti.xpt ts.xpt tv.xpt co.xpt dm.xpt cm.xpt ex.xpt ae.xpt ds.xpt mh.xpt da.xpt eg.xpt ie.xpt lb.xpt pe.xpt qs.xpt sc.xpt vs.xpt suppae.xpt suppcm.xpt suppdm.xpt suppex.xpt supplb.xpt suppsv.xpt suppvs.xpt NONE STUDY DRUG DOSE REDUCED STUDY DRUG STOPPED TEMPORARILY STUDY DRUG DISCONTINUED NOT RELATED POSSIBLY RELATED RELATED MILD MODERATE SEVERE QD BID TID QID QOD STAT Once a week Once a month PRN Other Very much improved Much Improved Minimally Improved No change Minimally worse Much worse Very much worse Concomitant Medications Psychotrophic Drug Treatment History PO SC IM IV Rectal Topical Nasal Inhaled SL Other CLINICALLY SIGNIFICANT HIGH CLINICALLY SIGNIFICANT LOW mg ug g mL ug/Kg mg/Kg mL/Kg mL/hr IU Tab(s) Cap(s) Other DISPOSITION EVENT PROTOCOL MILESTONE ADVERSE EVENT COMPLETED DID NOT MEET CRITERIA INFORMED CONSENT RANDOMIZED Some High School High School Graduate/GED Some College College Graduate Graduate Degree & Beyond Other HISPANIC OR LATINO NOT HISPANIC OR LATINO Single Married Separated Living With Partner Divorced Widowed Absent Mild Severe H L N ABNORMAL EXCLUSION INCLUSION Chemistry Hematology Urinalysis Allergies Endocrine-Metabolic Eyes-Ears-Nose-Throat Genitourinary Musculoskeletal Neurological MEDICAL AND SURGICAL HISTORY PSYCHIATRIC HISTORY Normal Abnormal/Not CS Abnormal/CS NO NOT APPLICABLE YES NO UNKNOWN YES WHITE BLACK ASIAN HISPANIC OTHER GROUPING QUALIFIER IDENTIFIER QUALIFIER RECORD QUALIFIER RESULT RESULT QUALIFIER RULE SYNONYM QUALIFIER TIMING TOPIC VARIABLE QUALIFIER FEMALE MALE UNKNOWN BEFORE DURING AFTER DURING/ AFTER U