CDISC01 CDISC Test Study CDISC01 DISPAMT RETAMT INTP PRMEAN QRSDUR QTMEAN VRMEAN QTCB QTCF EXCL01 EXCL02 EXCL03 INCL01 INCL02 INCL03 BILI CHEMISTRY BLOOD BUN CHEMISTRY BLOOD GLUC CHEMISTRY BLOOD GLUC URINALYSIS URINE DIPSTICK GLUC URINALYSIS URINE QUANT HCT HEMATOLOGY BLOOD HGB HEMATOLOGY BLOOD LYM HEMATOLOGY BLOOD OCCBLD URINALYSIS URINE PH URINALYSIS URINE VITB12 CHEMISTRY SERUM VITB9 CHEMISTRY BLOOD PE01 PE02 PE03 PE04 PE05 PE06 PE07 PE08 PE09 CGIGLOB CSDD01 CSDD02 CSDD03 CSDD04 CSDD05 CSDD06 CSDD07 CSDD08 CSDD09 CSDD10 CSDD11 CSDD12 CSDD13 CSDD14 CSDD15 CSDD16 CSDD17 CSDD18 CSDD19 CSDDTOT MMSEA1 MMSEA2 MMSEB MMSEC MMSED MMSEET MMSETOT EDLEVEL MARISTAT SUBJINIT AETRTEM HLGT HLT LLT ATC4CODE ATC4TERM CPREFCD PDDREAS PDRESP RACE1 RACE2 RACE3 RACEOTH RAND RANDNO SAFETY EGCLSIG SMNO LBCLSIG RTRINIT VSCLSIG ADDON AGEMAX AGEMIN AGESPAN AGEU DOSE DOSFRQ DOSU LENGTH OBJPRIM OBJSEC PLANSUB RANDOM ROUTE SEXPOP SPONSOR TBLIND TCNTRL TINDTP TITLE TPHASE TRT TTYPE DIABP FRMSIZE HEIGHT PULSE SYSBP WEIGHT HEIGHT CAN MEX HEIGHT USA WEIGHT CAN MEX WEIGHT USA Trial Arms ta.xpt Trial Elements te.xpt Trial Inclusion/Exclusion Criteria ti.xpt Trial Summary ts.xpt Trial Visits tv.xpt Demographics dm.xpt Subject Elements se.xpt Subject Visits sv.xpt Concomitant Medications cm.xpt Exposure ex.xpt Adverse Events ae.xpt Disposition ds.xpt Medical History mh.xpt Drug Accountability da.xpt ECG Test Results eg.xpt Inclusion/Exclusion Criteria Not Met ie.xpt Laboratory Tests Results lb.xpt Physical Examination pe.xpt Questionnaire-QSCG qscg.xpt Questionnaire-QSCS qscs.xpt Questionnaire-QSMM qsmm.xpt Subject Characteristics sc.xpt Vital Signs vs.xpt Related Records relrec.xpt Supplemental Qualifiers for AE suppae.xpt Supplemental Qualifiers for CM suppcm.xpt Supplemental Qualifiers for DM suppdm.xpt Supplemental Qualifiers for EG suppeg.xpt Supplemental Qualifiers for EX suppex.xpt Supplemental Qualifiers for LB supplb.xpt Supplemental Qualifiers for QSCG suppqscg.xpt Supplemental Qualifiers for QSCS suppqscs.xpt Supplemental Qualifiers for QSMM suppqsmm.xpt Supplemental Qualifiers for VS suppvs.xpt Action Taken with Study Treatment Body System or Organ Class Dictionary-Derived Term End Date/Time of Adverse Event Study Day of End of Adverse Event End Relative to Reference Period Modified Reported Term Causality Sequence Number Serious Event Severity/Intensity Sponsor-Defined Identifier Start Date/Time of Adverse Event Study Day of Start of Adverse Event Reported Term for the Adverse Event Domain Abbreviation Category for Medication Medication Class Medication Class Code Standardized Medication Name Dosing Frequency per Interval Dose Description Dose Units End Date/Time of Medication Study Day of End of Medication End Relative to Reference Period Indication Modified Reported Name Route of Administration Sequence Number Start Date/Time of Medication Study Day of Start of Medication Reported Name of Drug, Med, or Therapy Domain Abbreviation Date/Time of Accountability Assessment Study Day of Accountability Assessment Assessment Result in Original Units Dispensed Amount Returned Amount Original Units Sequence Number Assessment Result in Std Format Numeric Result/Finding in Standard Units Assessment Standard Units Name of Accountability Assessment Short Name of Accountability Assessment Domain Abbreviation Visit Name Planned Study Day of Visit Visit Number Age Age Units Description of Planned Arm Planned Arm Code Date/Time of Birth Country Domain Abbreviation Ethnicity Race Subject Reference End Date/Time Subject Reference Start Date/Time Sex Study Site Identifier Subject Identifier for the Study Domain Abbreviation Category for Disposition Event Standardized Disposition Term Sequence Number Start Date/Time of Disposition Event Study Day of Start of Disposition Event Reported Term for the Disposition Event Epoch Domain Abbreviation Baseline Flag Derived Flag Date/Time of ECG Study Day of ECG Evaluator Result or Finding in Original Units Interpretation: Original Results Summary (Mean) PR Duration (Orig U) Summary (Mean) QRS Duration (Orig U) Summary (Mean) QT Duration (Orig U) Summary (Mean) Ventricular Rate (Orig U) Original Units ECG Position of Subject Sequence Number Sponsor-Defined Identifier Character Result/Finding in Std Format QTcB - Bazett's Correction Formula QTcF - Fridericia's Correction Formula Numeric Result/Finding in Standard Units Standard Units ECG Test or Examination Name ECG Test or Examination Short Name Visit Name Planned Study Day of Visit Visit Number Domain Abbreviation Dose per Administration Dose Form Dose Units End Date/Time of Treatment Study Day of End of Treatment Sequence Number Start Date/Time of Treatment Study Day of Start of Treatment Name of Actual Treatment Domain Abbreviation Inclusion/Exclusion Category Date/Time of Collection I/E Criterion Original Result Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment Is unable or unwilling to undergo multiple venipunctures Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years Is age 18 - 85 Has Xyz disease of at least 10 weeks duration confirmed by biopsy Did not respond to a standard course of medication Abc Sequence Number I/E Criterion Result in Std Format Inclusion/Exclusion Criterion Inclusion/Exclusion Criterion Short Name Visit Name Visit Number Domain Abbreviation Baseline Flag Category for Lab Test Date/Time of Specimen Collection Study Day of Specimen Collection Fasting Status Method of Test or Examination Reference Range Indicator Reference Range Upper Limit in Orig Unit Reference Range Lower Limit in Orig Unit Result or Finding in Original Units Bilirubin Blood Urea Nitrogen Glucose Glucose Glucose Hematocrit Hemoglobin Lymphocytes Occult Blood pH Vitamin B12 Vitamin B9 Original Units Specimen ID Sequence Number Specimen Type Reference Range for Char Rslt-Std Units Reference Range Upper Limit-Std Units Reference Range Lower Limit-Std Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Lab Test or Examination Name Lab Test or Examination Short Name Visit Name Planned Study Day of Visit Visit Number Domain Abbreviation Body System or Organ Class Category for Medical History Date/Time of History Collection End Relative to Reference Period Medical History Occurrence Medical History Event Pre-Specified Sequence Number Start Date/Time of Medical History Event Reported Term for the Medical History Domain Abbreviation Date/Time of Examination Study Day of Examination Verbatim Examination Finding Appearance/Skin Head/Neck (Including Thyroid) Eyes-Ears-Nose-Throat Cardiovascular Pulmonary Abdomen Neurological Musculoskeletal Other Sequence Number Character Result/Finding in Std Format Body System Examined Body System Examined Short Name Visit Name Planned Study Day of Visit Visit Number Domain Abbreviation Baseline Flag Category of Question Date/Time of Finding Study Day of Finding Evaluation Interval Finding in Original Units Global Improvement Anxiety Sadness Lack of Reactivity to Pleasant Events Irritability Agitation Retardation Multiple Physical Complaints Loss of Interest Appetite Loss Weight Loss Lack of Energy Diurnal Variation of Mood Difficulty Falling Asleep Multiple Awakenings During Sleep Early Morning Awakening Suicide Poor Self-Esteem Pessimism Mood-Congruent Delusions Total Score Orientation time score Orientation place score Registration Attention and Calculation Recall Language Total Score Subcategory for Question Sequence Number Character Result/Finding in Std Format Numeric Finding in Standard Units Question Name Question Short Name Visit Name Planned Study Day of Visit Visit Number Related Domain Abbreviation Identifying Variable Identifying Variable Value Relationship Identifier Relationship Type Domain Abbreviation Date/Time of Collection Study Day of Examination Result or Finding in Original Units Education Level Marital Status Subject Initials Sequence Number Character Result/Finding in Std Format Subject Characteristic Subject Characteristic Short Name Domain Abbreviation Description of Element Element Code End Date/Time of Element Sequence Number Start Date/Time of Element Planned Order of Elements within Arm Study Identifier Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Treatment Emergent Flag High Level Group Term High Level Term Lowest Level Term Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value WHODRUG ATC Level 4 Code ATC4 Drug Class Term WHODRUG Drug Code Reason for Discontinuation Response Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Race 1 Race 2 Race 3 Race, Other Randomized Population Flag Randomization Number Safety Population Flag Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Clinically Significant Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Number of Tablets Per Day Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Clinically Significant Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Rater Initials Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Qualifier Variable Name Origin Data Value Clinically Significant Domain Abbreviation End Date/Time of Visit Start Date/Time of Visit Study Day of Start of Visit Visit Name Planned Study Day of Visit Visit Number Description of Planned Arm Planned Arm Code Domain Abbreviation Description of Element Epoch Element Code Branch Order of Element within Arm Transition Rule Domain Abbreviation Description of Element Element Code Planned Duration of Element Rule for Start of Element Domain Abbreviation Inclusion/Exclusion Category Inclusion/Exclusion Criterion Incl/Excl Criterion Short Name Domain Abbreviation Trial Summary Parameter Trial Summary Parameter Short Name Sequence Number Parameter Value Added on to Existing Treatments Planned Maximum Age of Subjects Planned Minimum Age of Subjects Age Span Age Unit Dose per Administration Dosing Frequency Dose Units Trial Length Trial Primary Objective Trial Secondary Objective Planned Number of Subjects Trial is Randomized Route of Administration Sex of Participants Clinical Study Sponsor Trial Blinding Schema Control Type Trial Indication Type Trial Title Trial Phase Classification Investigational Therapy or Treatment Trial Type Planned Arm Code Domain Abbreviation Visit Start Rule Visit Name Planned Study Day of Visit Visit Number Unique Subject Identifier Domain Abbreviation Visit Name Planned Study Day of Visit Visit Number Baseline Flag Date/Time of Measurements Study Day of Vital Signs Result or Finding in Original Units Diastolic Blood Pressure (Orig U) Body Frame Size (Orig U) Height (Orig U) Pulse Rate (Orig U) Systolic Blood Pressure (Orig U) Weight (Orig U) Original Units Vital Signs Position of Subject Sequence Number Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Height: Original Units Height: Original Units Height: Original Units Height: Original Units Vital Signs Test Name Vital Signs Test Short Name Adverse Events Grade 1 Grade 2 Grade 3 Placebo Screen Failure Miracle Drug 10 mg Miracle Drug 20 mg Very much improved Much Improved Minimally Improved No change Minimally worse Much worse Very much worse Concomitant Meds Absent Mild or Intermittent Severe Drug Accountability Dispensed Amount Returned Amount Demographics Disposition Disposition Event Protocol Milestone Electrocardiogram Beats per Minute Millisecond Interpretation Summary (Mean) PR Duration Summary (Mean) QRS Duration QTcB - Bazett's Correction Formula QTcF - Fridericia's Correction Formula Summary (Mean) QT Duration Summary (Mean) Ventricular Rate Exposure BD Once Other As needed Every 24 hours 4 times per day Every other day Every week 3 times per day tab Inclusion/Exclusion Is pregnant, nursing, or planning to become pregnant within 6 months of last study treatment Is unable or unwilling to undergo multiple venipunctures Is known to have had a substance abuse (drug or alcohol) problem within the previous 3 years Is age 18 - 85 Has Xyz disease of at least 10 weeks duration confirmed by biopsy Did not respond to a standard course of medication Abc Laboratory Data Bilirubin Blood Urea Nitrogen Glucose Hematocrit Hemoglobin Lymphocytes Occult Blood pH Vitamin B12 Vitamin B9 Medical History No Unknown Yes No Not Applicable Yes Physical Exam Appearance/Skin Head/Neck (Including Thyroid) Eyes-Ears-Nose-Throat Cardiovascular Pulmonary Abdomen Neurological Musculoskeletal Other Questionnaires Global Improvement Anxiety Sadness Lack of Reactivity to Pleasant Events Irritability Agitation Retardation Multiple Physical Complaints Loss of Interest Appetite Loss Weight Loss Lack of Energy Diurnal Variation of Mood Difficulty Falling Asleep Multiple Awakenings During Sleep Early Morning Awakening Suicide Poor Self-Esteem Pessimism Mood-Congruent Delusions Total Score Orientation time score Orientation place score Registration Attention and Calculation Recall Language Total Score Subject Characteristics Education Level Marital Status Subject Initials Subject Element Female Male Unknown Subject Visits Trial Arms Trial Elements Trial Inclusion/Exclusion Criteria Trial Summary Added on to Existing Treatments Planned Maximum Age of Subjects Planned Minimum Age of Subjects Age Span Age Unit Dose per Administration Dosing Frequency Dose Units Trial Length Trial Primary Objective Trial Secondary Objective Planned Number of Subjects Trial is Randomized Route of Administration Sex of Participants Clinical Study Sponsor Trial Blinding Schema Control Type Trial Indication Type Trial Title Trial Phase Classification Investigational Therapy or Treatment Trial Type Trial Visits Centimeter Inch Kilogram Pound Vital Signs Beats per Minute Centimeter Kilogram Millimeter of Mercury Diastolic Blood Pressure Body Frame Size Height Pulse Rate Systolic Blood Pressure Weight AEENDY = AEENDTC -RFSTDTC+1 if AEENDTC is on or after RFSTDTC. AEENDTC - RFSTDTC if AEENDTC precedes RFSTDTC AESTDY = AESTDTC - RFSTDTC+1 if AESTDTC is on or after RFSTDTC. AESTDTC - RFSTDTC if AESTDTC precedes RFSTDTC AETRTEM = "Y" if Adverse Event was not present prior to the RFSTDTC, or it was present prior to the RFSTDTC but increased in severity during the treatment period. Null otherwise. Age at Screening Date (Screening Date - Birth date). For the complete algorithm see the referenced external document. Only created if value qualifies as potentially clinically significant high or low based on the high and low ranges specified in the Statistical Analysis Plan. CMENDY = CMENDTC - RFSTDTC +1 if CMENDTC is on or after RFSTDTC. CMENDTC - RFSTDTC if CMENDTC precedes RFSTDTC CMSTDY = CMSTDTC - RFSTDTC +1 if CMSTDTC is on or after RFSTDTC. CMSTDTC - RFSTDTC if CMSTDTC precedes RFSTDTC Derived from DADTC and SVSTDTC. DADY = DADTC - RFSTDTC+1 if DADTC is on or after RFSTDTC. DADTC - RFSTDTC if DADTC precedes RFSTDTC. DASTRESC = DAORRES DASTRESN = numeric value of DAORRES, when DAORRES contains numeric data. DASTRESU = DAORRESU DSSTDY = DSSTDTC - RFSTDTC+1 if DSSTDTC is on or after RFSTDTC. DSSTDTC - RFSTDTC if DSSTDTC precedes RFSTDTC. Null if RFSTDTC is Null. Safety subjects only: EGBLFL = "Y" for last record with non Null EGORRES on or before the first dose date (RFSTDTC). Null otherwise EGDRVFL = "Y" for derived EGTESTCDs QTCB and QTCF. Null otherwise. EGDY = EGDTC-RFSTDTC+1 if EGDTC is on or after RFTSDTC. EGDTC - RFSTDTC if EGDTC precedes RFSTDTC. Data collected in non-standard units is converted using standard conversion factors to standard units. EGSTRESN = numeric value of EGSTRESC, when EGSTRESC contains numeric data. If ARMCD=WONDER10 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 10. If ARMCD=WONDER20 then EXDOSE = Number of Tablets per Day (QVAL where QNAM=SMNO) * 20. If ARMCD=PLACEBO then EXDOSE = 0. Derived from ARM, ARMCD - equal to mg EXENDY = EXENDTC-RFSTDTC+1 if EXENDTC is on or after RFSTDTC. EXENDTC - RFSTDTC if EXENDTC precedes RFSTDTC. EXSTDY = EXSTDTC - RFSTDTC+1 if EXSTDTC is on or after RFSTDTC. EXSTDTC - RFSTDTC if EXSTDTC precedes RFSTDTC. Derived from ARM, ARMCD IESTRESC = IEORRES Safety subjects only: LBBLFL = "Y" for last record with non Null LBORRES on or before the first dose date (RFSTDTC). Null otherwise. LBDY = LBDTC-RFSTDTC+1 if LBDTC is on or after RFSTDTC. LBDTC - RFSTDTC if LBDTC precedes RFSTDTC. Reference Range Indicator based upon standard results and ranges. PEDY = PEDTC-RFSTDTC+1 if PEDTC is on or after RFSTDTC. PEDTC - RFSTDTC if PEDTC precedes RFSTDTC. PESTRESC = PEORRES Safety subjects only: QSBLFL = "Y" for last record with non Null QSORRES on or before the first dose date (RFSTDTC). Null otherwise. QSDY= QSDTC-RFSTDTC+1 if QSDTC is on or after RFSTDTC. QSDTC - RFSTDTC if QSDTC precedes RFSTDTC. If questionnaire result is a numerically relevant code then code stored here; else character result equal to QSORRES. Character results contain mixed case data. When QSORRES is numeric then QSSTRESN equal to numeric result QTcB = QT interval / square root of (60 / heart rate). For the complete algorithm see the referenced external document. QTcF = QT interval / cubic root of (60 / heart rate). For the complete algorithm see the referenced external document. Domain abbreviation from where data originated. All records for the same USUBJID with the same RELID are considered related. RFENDTC = termination date, for safety subjects. Null for screen failures. RFSTDTC = first date/time of study drug, for safety subject. Null for screen failures. SAFETY = "Y" for randomized subjects who took at least one dose study medication. Null otherwise. SCDY = SCDTC-RFSTDTC+1 if SCDTC is on or after RFSTDTC. SCDTC - RFSTDTC if SCDTC precedes RFSTDTC. SCSTRESC = SCORRES If Element = SCREEN, derived from SVENDTC where VISIT = SCREENING. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT or from the latest EXENDTC from EX whichever is later. For treatment Elements, derived from last EXENDTC for the element. For the complete algorithm see the referenced external document. Sequential number identifying records within each USUBJID in the domain. If Element = SCREEN, derived from SVSTDTC where VISIT = SCREENING or from DS where DSDECOD = 'INFORMED CONSENT', whichever is earliest. If Element = EOS, derived from DS where DSCAT = DISPOSITION EVENT. For treatment Elements, derived from first EXSTDTC for the element. For the complete algorithm see the referenced external document. Derived from visit-based subject-level domains Derived from visit-based subject-level domains SVENDTC = SVSTDTC Derived from visit-based subject-level domains SVSTDY = SVSTDTC-RFSTDTC+1 if SVSTDTC is on or after RFSTDTC. SVSTDTC - RFSTDTC if SVSTDTC precedes RFSTDTC. Sequential number identifying records within each TSPARM in the domain. Concatenation of STUDYID and SUBJID catx(".",STUDYID,SUBJID) Safety subjects only: VSBLFL = "Y" for last record with non Null VSORRES on or before the first dose date (RFSTDTC). Null otherwise. VSDY = VSDTC-RFSTDTC+1 if VSDTC is on or after RFSTDTC. VSDTC - RFSTDTC if VSDTC precedes RFSTDTC. Data collected in non-standard units (i.e. lbs, inches) is converted using standard conversion factors to standard units (kg, cm). VSSTRESN = numeric value of VSSTRESC, when VSSTRESC contains numeric data. Defaulted to YEARS Assigned from TA.ARM based on ARMCD. Assigned based on Randomization Number. See Note 2.1 Coded to ATC level 3 Term based on CMINDC Coded to ATC level 3 Code based on CMINDC Free text from CRF mapped to CDISC CT See Reviewer's Guide, Section 2.1 Demographics QS is submitted as a split dataset. The split was done based on QSCAT as QSCG (CLINICAL GLOBAL IMPRESSIONS), QSCS (CORNELL SCALE FOR DEPRESSION INDEMENTIA) and QSMM (MINI MENTAL STATE EXAMINATION). See additional documentation in the Reviewer's Guide, Split Datasets Section. CRF controlled terminology was mapped to match CDISC controlled terminology. Assigned from the TV domain based on the VISIT Equal to INVESTIGATOR for CRF data Equal to SUPINE ECG parameter ordering variable Name of the variables for the related records. Value of identifying variable described in IDVAR. Assigned from the TV domain based on the VISIT Accession number Assigned for Medical History but not Psychiatric History CRF controlled terminology was mapped to match CDISC controlled terminology. Assigned from the TV domain based on the VISIT Assigned from the TV domain based on the VISIT All values are null since this is used only when identifying a dataset-level relationship. The data submitted only includes subjects in the USA since other sites did not enroll any subjects. Join any Subject Level dataset with the Demographics dataset based on [IG.datasetname]IT.USUBJID = [IG.DM]IT.USUBJID, assuming 'IG.datasetname' is the OID of the ItemGroupDef that defines the subject-level dataset to be joined with the Demographics dataset. QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17 Assigned from the TV domain based on the VISIT Standard units consistent with CDISC controlled terminology Annotated Case Report Form Reviewers Guide Complex Algorithms