Concept Lesson Lesson Title Keywords
Full ADSL - Subject Level Analysis Dataset ADaM_ADSL_L1101ADSL dataset for a parallel arm study - MYCSG-001CDISC, ADaM, ADSL, Complete program
Full ADAE - Adverse Events Analysis Dataset ADaM_ADAE_L1101ADAE dataset for a parallel arm study - MYCSG-001ADaM, ADAE, Adverse Events, TRTMFL, APHASE, PREFL, FUPFL
Full ADCM - Concomitant Medication Analysis Dataset ADaM_ADCM_L1101ADCM dataset for a parallel arm study - MYCSG-001ADaM, ADCM, Concomitant Medications
Full ADCM - Concomitant Medication Analysis Dataset ADaM_ADCM_LCMSUM01ADCM summary dataset in a diabetes studyADCMSUM, ADaM, Rescue medication summary
Full ADEXSUM - Exposure Summary Analysis Dataset ADaM_ADEXSUM_L1101ADEXSUM dataset for a parallel arm study - MYCSG-001ADaM, ADaM Other, ADEXSUM
Full ADEG - ECG Analysis Dataset ADaM_ADEG_L1101ADEG dataset in a parallel arm studyADaM, BDS, ADEG, ECG Analysis Dataset, CDISC
Full ADIS - Immunogenicity Analysis Dataset ADaM_ADIS_LVAC01ADIS - Immune response in a vaccine study - 001Clinical Programming, ADaM, ADIS, Immunogenicity
Full ADPC - Pharmacokientic Concentrations ADaM_ADPC_LOD101Analysis Dataset for Pharmacokientic Concentrations - Oral dosing 101ADaM, ADPC, Pharamacokinetic concentrations
Full ADQS - Questionnaire Analysis Dataset ADaM_ADQS_L1101ADQSEQ5D dataset for a parallel arm study - MYCSG-001ADaM, BDS, ADQS, EQ5D-5L
Full ADQS - Questionnaire Analysis Dataset ADaM_ADQS_LEASI01ADQSEASI - Eczema Area and Severity IndexADaM, BDS, ADQS, EASI
Full ADRS - Response Analysis Dataset ADaM_ADRS_L1101ADRS dataset - Best overall responseADRS, Oncology, Best overall response, BESTRESP
Full ADVS - Vital Signs Analysis Dataset ADaM_ADVS_L1101ADVS dataset for a parallel arm study - MYCSG-001ADaM, BDS, ADVS, Vital Signs Analysis Dataset, CDISC
Full Other BDS - Other BDS datasets ADaM_BDS_LADICE01Analysis Dataset for Intercurrent EventsADaM, Intercurrent Events
Subject Level Analysis Data ADaM_C1001_L101Derivation of key date variables which are commonly used on ADSLADaM,ADSL,Key dates, RFICDT, RANDDT, TRTSDT, TRTEDT, FVISDT, LVISDT
Subject Level Analysis Data ADaM_C1001_L102Derivation of subject level population flags which are commonly used in ADSLADaM SCRFFL RANDFL SAFFL FASFL PPROTFL
Subject Level Analysis Data ADaM_C1001_L102aSafety flag ? special case using Drug accountability and Exposure datasetsADaM,TRTSDT,TRTEDT,SAFFL,SAF2FL
Subject Level Analysis Data ADaM_C1001_L103Different Treatment related variables - Parallel group studyADaM,ADSL,Treatment Group, TRT01P, TRT01A
Subject Level Analysis Data ADaM_C1001_L103aDifferent Treatment related variables - Two period cross-over studyADaM,ADSL,Treatment variables,Cross over study
Subject Level Analysis Data ADaM_C1001_L103bDifferent Treatment grouping variables ? Parallel group studyADaM,ADSL,Pooled Treatment Group, TR01PG1, TR01AG1
Subject Level Analysis Data ADaM_C1001_L104Creation of baseline variables: HEIGHTBL and WEIGHTBLADaM,ADSL,Baseline, Baseline variables, HEIGHTBL, WEIGHTBL, TRANSPOSE, LAST.
Subject Level Analysis Data ADaM_C1001_L105Creation of grouping variables: both character and numeric variablesADaM, ADSL, AGEGRy, SITEGRy, BMIGRy, FREQ
Subject Level Analysis Data ADaM_C1001_L106Derivation of variables related to end of treatment and end of studyADaM, ADSL, EOTSTT, EOTDT, DCTREAS, EOSSTT, EOSDT, DCSREAS
Dates and Date imputations ADaM_C1002_L101Conversion of character dates of ISO 8601 to numeric date, time and date time valuesNumeric dates, ASTDT, ASTTM, ASTDTM
Dates and Date imputations ADaM_C1002_L102Imputation of missing date components: 01 for missing day, JAN for missing monthDates imputation,Imputation flag, ASTDT, ASTDTF
Dates and Date imputations ADaM_C1002_L102aImputation of missing date components: 01 for missing day, JAN for missing month for start date. Last day of the month and DEC for month for end date.Dates imputation,Imputation flag, ASTDT, ASTDTF,AENDT, AENDTF
Dates and Date imputations ADaM_C1002_L103Imputation of missing date components: based on treaatment start date of the subjectDates imputation ,Imputation flag, ASTDT, ASTDTF
Treament emergence, pre and post treatment occurrences ADaM_C1003_L101Adverse Event Treatment Emergence Flag - basic exampleTRTEMFL
Treament emergence, pre and post treatment occurrences ADaM_C1003_L102Adverse Event Treatment Emergence Flag - considering the baseline severityTRTEMFL
Treament emergence, pre and post treatment occurrences ADaM_C1003_L102aAdverse Event Treatment Emergence Flag - considering the baseline severity and cutoff after treatment end dateTRTEMFL
Treament emergence, pre and post treatment occurrences ADaM_C1003_L103Treatment Emergent Adverse Event Flag in crossover studyTRTEMFL Crossover study Analysis periods
Treament emergence, pre and post treatment occurrences ADaM_C1003_L103aTreatment Emergent Adverse Event Flag in crossover study, separate flag for each periodTRTEMFL Crossover study Analysis periods
ADaM BDS Derived Parameters Creation ADaM_C1004_L101Creation of a New Parameter to Handle a Transformation (Log transformation of weight)ADaM, BDS, Derived parameters, AVAL Transformation, LOG10, L10WT, Rule 2
ADaM BDS Derived Parameters Creation ADaM_C1004_L102Creation of a New Parameter to Handle a Second System of Units (Height in both cm and m)ADaM, BDS, Derived parameters, AVAL Transformation, HEIGHTMT, Rule 2
ADaM BDS Derived Parameters Creation ADaM_C1004_L103Creation of New Parameter to Handle a Function of More Than One Parameter (MAP - Mean Arterial Pressure)ADaM, BDS, Derived parameters, Function of more than one parameter, MAP, Rule 5
ADaM BDS Derived Parameters Creation ADaM_C1004_L103aCreation of New Parameter to Handle a Function of More Than One Parameter (BMI)ADaM, BDS, Derived parameters, Function of more than one parameter, BMI, Rule 5
ADaM BDS Derived Parameters Creation ADaM_C1004_L103bCreation of New Parameter to Handle a Function of More Than One Parameter (HDL/LDL ratio)ADaM, BDS, Derived parameters, Function of more than one parameter, HDLLDL, Rule 5
ADaM BDS Derived Parameters Creation ADaM_C1004_L103cCreation of New Parameter to Handle a Function of More Than One Parameter (EQ5D-Composite Health Index)ADaM, BDS, Derived parameters, Function of more than one parameter, CHI, Rule 5
ADaM BDS - Derived records creation ADaM_C1005_L101Creation of new records to hold the minimum value across postbaseline recordADaM, BDS, Derived records, DTYPE, MINIMUM POSTBASELINE
ADaM BDS - Derived records creation ADaM_C1005_L101aCreation of new records to hold the maximum value across postbaseline recordADaM, BDS, Derived records, DTYPE, MAXIMUM POSTBASELINE
ADaM BDS - Derived records creation ADaM_C1005_L101bCreation of new records to hold the minimum and maximum values across postbaseline periodADaM, BDS, Derived records, DTYPE, MINIMUM POSTBASELINE, MAXIMUM POSTBASELINE
ADaM BDS - Derived records creation ADaM_C1005_L102Creation of a new record, as average of all postbaseline values of a parameterADaM, BDS, Derived records, DTYPE, AVERAGE POSTBASELINE
ADaM BDS - Derived records creation ADaM_C1005_L103Creation of a new record, as average of triplicate measurements of QTcBADaM, BDS, DTYPE, Average of triplicate measurements, ECG, QTCB
ADaM BDS - Baseline Concepts ADaM_C1006_L101Creation of baseline flag, last record on or prior to treatment startADaM, BDS, Baseline flag, ABLFL
ADaM BDS - Baseline Concepts ADaM_C1006_L101aCreation of baseline flag, base, chg and pchg variablesADaM, BDS, Baseline flag, ABLFL,BASE,CHG,PCHG
ADaM BDS - Baseline Concepts ADaM_C1006_L102Creation of baseline flag and related variables using the concept of MINIMUM basetypeADaM, BDS, Baseline flag,Minimum pretreatment value as baseline, ABLFL,BASE,CHG,PCHG
ADaM BDS - Baseline Concepts ADaM_C1006_L102aCreation of Baseline flag and related variables using the concept of MAXIMUM basetypeADaM, BDS, Baseline flag,Maximum pretreatment value as baseline, ABLFL,BASE,CHG,PCHG
ADaM BDS - Baseline Concepts ADaM_C1006_L102bCreation of Baseline flag and related variables using the concept of MINIMUM and MAXIMUM basetypes, within a single dataset on different parameters.ADaM, BDS, Baseline flag,Different basetype for different parameters, ABLFL,BASE,CHG,PCHG
ADaM BDS - Baseline Concepts ADaM_C1006_L102cCreation of baseline flag and related variables using the concept of MINIMUM and MAXIMUM basetypes along with ORIGINAL basetype, within a single dataset on different parameters.ADaM, BDS, Baseline flag,Different basetype for different parameters, ABLFL,BASE,CHG,PCHG
ADaM BDS - Baseline Concepts ADaM_C1006_L102dCreation of baseline flag and related variables using the concept of AVERAGE of screening period records as baseline.ADaM, BDS, Baseline flag,Screening Average as Baseline, ABLFL,BASE,CHG,PCHG
ADaM BDS - Visit Windowing ADaM_C1007_L101Creation of visit windowing based on ADY and prespecified intervals - parameter invariantADaM, BDS, Visit Windowing, AWTARGET, AWLO, AWHI, AVISIT
ADaM BDS - Visit Windowing ADaM_C1007_L102Creation of visit windowing based on ADY and prespecified intervals - parameter variantADaM, BDS, Visit Windowing, AWTARGET, AWLO, AWHI, AVISIT
Record level treatment variables ADaM_C1008_L101Actual Treatment in Adverse Events dataset in a 3 period crossover studyTRTA, TRTP, APERIOD, Record level treatment variables
ADaM BDS - Analysis Flags ADaM_C1009_L101Creation of ANL01FL, multiple record within an analysis visit. Closest and earliest record will be chosenADaM, BDS, Visit Windowing, Analysis Flags, ANL01FL
ADaM BDS - Analysis Flags ADaM_C1009_L102Creation of ANL01FL, multiple record within an analysis visit. Closest and latest record will be chosenADaM, BDS, Visit Windowing, Analysis Flags, ANL01FL
ADaM BDS - Analysis Flags ADaM_C1009_L103Creation of ANL01FL, multiple record at a timepoint, average result for analysisADaM, BDS, Analysis Flags, ANL01FL, DTYPE
ADaM BDS - Analysis Flags ADaM_C1009_L104Creation of ANL02FL, to identify postbaseline records - date aloneADaM BDS, Analysis Flags, ANL02FL, Postbaseline analysis records
ADaM BDS - Analysis Flags ADaM_C1009_L105Creation of ANL03FL, to identify subjects with an abnormal postbaseline shift - ADEGADaM, BDS, Analysis Flags, Abnormal result, Shift
ADaM BDS - Analysis Flags ADaM_C1009_L106ADLB - Creation of Analysis flags to identify worst postbaseline toxicity gradesADaM, BDS, Analysis Flags, ANL04FL, ANL05FL
ADaM BDS - Data Imputation ADaM_C1010_L101LOCF-Record present, result missing - using analysis visits-single parameterADaM, BDS, Imputation, LOCF
ADaM BDS - Data Imputation ADaM_C1010_L102LOCF-Records missing - using analysis visits-single parameterADaM, BDS, Imputation, LOCF, Record absent
ADaM BDS - Data Imputation ADaM_C1010_L103LOCF-Records missing - using analysis visits-multiple parameters, with different parameters having different visit schedulesADaM, BDS, Imputation, LOCF, Record absent, Varied Schedule of assessments
ADaM BDS - Data Imputation ADaM_C1010_L103aLOCF-Records missing - using analysis visits-multiple parameters, with different parameters having different visit schedules, postbaseline visits onlyADaM, BDS, Imputation, LOCF, Record absent, Varied Schedule of assessments
ADaM BDS - Data Imputation ADaM_C1010_L111BLOCF-Record present, result missing - using analysis visits-single parameterADaM, BDS, Imputation, BLOCF
ADaM BDS - Criteria Flags ADaM_C1011_L101Single parameter- aval based criteria-populating variables only on the records where conditions are met-single parameterADaM, BDS, Criteria Flags, CRIT1, CRIT1FL
ADaM BDS - Criteria Flags ADaM_C1011_L101aSingle parameter- aval based criteria-crit on all rows, flag on met records- single parameterADaM, BDS, Criteria Flags, CRIT1, CRIT1FL
ADaM BDS - Criteria Flags ADaM_C1011_L101bMultiple parameters- aval based criteria-crit on all rows, flag on met recordsADaM, BDS, Criteria Flags, CRIT1, CRIT1FL
ADaM BDS - Criteria Flags ADaM_C1011_L101cSingle parameter- aval and chg based criteria-crit on all rows, flag on met recordsADaM, BDS, Criteria Flags, CRIT1, CRIT1FL
ADaM BDS - Criteria Flags ADaM_C1011_L101dMultiple parameters- multiple criteria - aval and chg based criteria-crit on all rows, flag on met recordsADaM, BDS, Criteria Flags, CRIT1, CRIT1FL, CRIT2, CRIT2FL
ADaM BDS - Criteria Flags ADaM_C1011_L201ADLB - Multi-Response Criterion flags - For toxicity grade increase of Alanine Amino TransferaseADaM, BDS, Criteria Flags, Multi-response criteria flags
ADaM BDS - Shift variables ADaM_C1012_L101ADLB - Shift from baseline - Normal Range Indicator (ANRIND, BNRIND)ADaM, BDS, Shift from baseline, Normal range indicator
ADaM BDS - Shift variables ADaM_C1012_L102ADLB - Shift from baseline - Toxicity Grade (ATOXGR, BTOXGR)ADaM, BDS, Shift from baseline, Toxicity Grade
Time to event related variables ADaM_C1013_L101Time to first rescue medicationAVAL,CNSR,Time to Event, Censor
Time to event related variables ADaM_C1013_L102Overall Survival - Time to Death - With Event DescriptionADaM, BDS, TTE, Overall Survival, Time to Death, Event Description
Time to event related variables ADaM_C1013_L103Overall Survival - Time to Death - Multiple Values for CensoringADaM, BDS, TTE, Overall Survival, Time to Death, Event Description
OCCDS specific variables ADaM_C1016_L101AOCCFL,AOCCSFL and AOCCPFL in Adverse EventsFirst Occurrence Flags, AOCCFL, AOCCSFL, AOCCPFL
ADaM_TEST998_TEST998a
ADaM_TEST998_TEST998bThis is full title
Macros for ADaM programming MACROS_ADaM_L110Create numeric date/time variables from SDTM ISO DTC variablesMacros, numeric dates
Macros for ADaM programming MACROS_ADaM_L120Create study day variable in ADaM datasetsStudy day
Macros for ADaM programming MACROS_ADaM_L130Create baseline flag and related variables - ABLFL, BASE, BASEC ...ABLFL, BASE, BASEC
Macros for General programming MACROS_GEN_L210Import multiple sheets from a single excel fileProc import macro
Macros for General programming MACROS_GEN_L310Run same code on multiple datasets - data stepSAS clinical macros
Macros for General programming MACROS_GEN_L311Run proc sort on multiple datasets - same by variablesSAS clinical macros
Macros for General programming MACROS_GEN_L312Run proc freq on multiple datasets - one or more tablesSAS clinical macros
Macros for General programming MACROS_GEN_L313Run proc sort nodupkey on multile datasets using same by variablesSAS clinical macros
Macros for General programming MACROS_GEN_L314Run proc sort NOuniquekeys on multile datasets using same by variablesSAS clinical macros
Macros for General programming MACROS_GEN_L401Create new folder on harddrive from a sas programSAS clinical macros
Macros for General programming MACROS_GEN_L402Get the file details in a folder/subfolders - OS specific commandsSAS clinical macros
Macros for General programming MACROS_GEN_L403Create/delete a temporary copy of the file for reading into SAS - OS based commandsSAS clinical macros
Macros for SDTM programming MACROS_SDTM_L251Macro to convert raw date values to ISO8601 formatSDTM,Macros,IS08601
Macros for SDTM programming MACROS_SDTM_L261Macro to create study day variable in SDTM datasetsSDTM, Macro, Study day
Macros for SDTM programming MACROS_SDTM_L271Macro to create sequence variable in SDTM datasetsSDTM, Macros, Sequence variable
Macros for SDTM programming MACROS_SDTM_L281Macro to create baseline flag in SDTM datasetsSDTM, Macro, Baseline flag
Introduction to SAS SAS_INTRO_L101Introduction to SAS
Reading Raw data in SAS SAS_READRAW_L101Reading raw data arranged in columns
Reading Raw data in SAS SAS_READRAW_L102Reading raw data separated by delimiters
Creating Data Subsets in SAS SAS_SUBSETTING_L101Basics of Subsetting Observations
Appending Datasets in SAS SAS_APPENDING_L101Appending datasets using SET statement
Merging Datasets in SAS SAS_MERGING_L101Match Merging in SAS
Data Step Features in SAS SAS_DATASTEP_L080Conditional Processing - Part 01
Data Step Features in SAS SAS_DATASTEP_L085Loops in SAS - Part 01
Data Step Features in SAS SAS_DATASTEP_L101Explicit Output Statement
Data Step Features in SAS SAS_DATASTEP_L103Arrays in SAS
Program Data Vector in SAS SAS_PDV_L101Understanding PDV in SAS
Functions in SAS SAS_FUNCTIONS_L101Character Functions in SAS
Functions in SAS SAS_FUNCTIONS_L201Numeric functions in SAS
Freq Procedure in SAS SAS_PROCFREQ_L101Proc Freq Basics
Means Procedure in SAS SAS_PROCMEANS_L101Proc Means Basics
Means Procedure in SAS SAS_PROCMEANS_L102Understanding _FREQ_ variable of the output dataset
Sort Procedure in SAS SAS_PROCSORT_L101Sorting of observations in a dataset
Sort Procedure in SAS SAS_PROCSORT_L102Handling duplicate records using proc sort
Sort Procedure in SAS SAS_PROCSORT_L103Fetching unique records using proc sort
Sort Procedure in SAS SAS_PROCSORT_L104Understanding Sort Sequence of Character Variables
Import Procedure in SAS SAS_PROCIMPORT_L101Proc import - Part 01
Export Procedure in SAS SAS_PROCEXPORT_L101Proc Export - part 01
Contents Procedure in SAS SAS_PROCCONTENTS_L101Proc Contents
Datasets Procedure in SAS SAS_PROCDATASETS_L101Proc datasets - part 01
Compare Procedure in SAS SAS_PROCCOMPARE_L101Proc Compare - Part 01
SQL Procedure in SAS SAS_PROCSQL_L101SQL Procedure in SAS - Part 01
Commonly Seen Log Issues in SAS SAS_LOGISSUES_L101Commonly Seen Log Issues in SAS - Part 01
Commonly used programming logics in clinical SAS SAS_COMMONLOGICS_L101Commonly used Logics 101
Adverse Events SDTM_AE_LCSG001Adverse Events Programming for study CSG001AE,SUPPAE,Adverse Events
Clinical Events SDTM_CE_LGE01CE - GastroenteritisSDTM,CE,Clinical Events, Gastroenteritis
Concomitant Medications SDTM_CM_LCSG001CM dataset Programming for study CSG001CM, Concomitant Medications
Cardiovascular System Findings SDTM_CV_L101Cardiovascular System Findings - Echocardiogram ResultsSDTM:CV, Echocardiogram results
Drug Accountability SDTM_DA_L101Drug Accountability - Dispensed and Returned CapsulesDA, Drug Accountability, DISPAMT, Dispensed Amount, RETAMT, Returned Amount
Death Details SDTM_DD_L101Death Details - date of death, autopsy, primary and secondary causes of deathSDTM DD, Death Details, AUTOPIND, PRCDTH, SECDTH
Demographics SDTM_DM_LCSG001Demographics dataset programmingSDTM,DM, Demographics
Disposition SDTM_DS_LCSG001Disposition dataset programmingSDTM,DS,Disposition, Protocol Milestones
Protocol Deviations SDTM_DV_L101Protocol Deviations - L101SDTM, Clinical trials programming, DV, Protocol Deviations
Exposure as Collected SDTM_EC_LCSG001EC dataset Programming for study CSG001EC, Exposure, Exposure as collected
ECG Test Results SDTM_EG_LCSG001ECG dataset Programming for study CSG001EG, ECG, Electrocardiogram
Exposure SDTM_EX_LCSG001EX dataset Programming for study CSG001EX, Exposure
Findings About Events or Interventions SDTM_FA_LGE01FA-GastroenteritisSDTM, FA, Findings About, Clinical Event, FAOBJ
Functional Tests SDTM_FT_L6MWTSDTM FT dataset - 6MWT - Six Minute Walk TestSDTM, FT, Functional Tests, 6MWT, Six Minute Walk Test
Healthcare Encounters SDTM_HO_L101Healthcare Encounters - reason, admission and discharge datesSDTM HO, Healthcare Encounters, Admission date, discharge date, reason for admission
Inclusion/Exclusion Criteria Not Met SDTM_IE_L101Inclusion/Exclusion Criteria Not MetSDTM IE, Inclusion/Exclusion Criteria Not Met
Immunogenicity Specimen Assessments SDTM_IS_LADABSDTM IS dataset - ADAB - Anti-Drug AntibodiesSDTM, IS, Immunogenicity Specimen Assessments, Antidrug Antibodies
Laboratory Test Results SDTM_LB_LCSG001LB dataset Programming for study CSG001SDTM, LB dataset programming, Chemistry, Hematology, Urinalysis
Medical History SDTM_MH_L201SDTM MH dataset - general history and cancer historyMH, Medical History, Ongoing events, partial dates
Medical History SDTM_MH_LCSG801MH dataset programming for study CSG801MH, Medical History, MHPRESP, Prespecified, MHOCCUR
Morphology SDTM_MO_L101Morphology - Kidney dimension using CT SCANSDTM MO, Morphology, Kidney morpholoy using CT SCAN
Pharmacokinetics Concentrations SDTM_PC_L101Pharmacokinetics Concentrations - Drug in plasmaSDTM, PC
Physical Examination SDTM_PE_L101Physical Examination - L101SDTM, PE
Pharmacokinetics Parameters SDTM_PP_L101Pharmacokinetics Parameters - Drug in plasmaSDTM,PP
Procedures SDTM_PR_L101Procedures - transfusions - date, type, volume and reasonSDTM PR, Procedures, transfusions, date and time, volume, reason for transfusion
Questionnaires SDTM_QS_LEQ5D3LSDTM QS dataset - EQ5D - 3 LevelsSDTM, QS, EQ-5D-3L, European Quality of Life Five Dimension Three Level Scale
Respiratory System Findings SDTM_RE_L101Respiratory System Findings - FVC, FEVSDTM, RE, FVC, FEV1
Related Records SDTM_RELREC_L101SDTM RELREC dataset - Relationship creation using raw datasetsRELREC, DSAE, CMAE, SDTM
Reproductive System Findings SDTM_RP_L101Reproductive System Findings - Childbearing Potential and Menopause StatusSDTM RP, Reproductive System Findings, CHILDPOT, MENOSTAT
Disease Response and Clin Classification SDTM_RS_LCHPUSDTM RS dataset - Child-Pugh ClassificationSDTM, RS, Disease Response and Clin Classification, Child-Pugh Classification
Disease Response and Clin Classification SDTM_RS_LONCEX06Disease Response - Investigator tumor identification, tumor results and response data using RECIST 1.1Clinical SAS, Oncology domains, SDTM
Subject Elements SDTM_SE_LCSG001Subject Elements programmingSE, Subject Elements
Substance Use SDTM_SU_L101Substance Use - Alcohol, tobacco, caffeineSDTM, SU, Alcohol, Caffeine, Tobacco
Subject Visits SDTM_SV_LCSG001Subject Visits programmingSDTM,SV,Subject Visits, Retain, Unscheduled Visits Remapping
Trial Arms SDTM_TA_LCSG801TA domain for an example study CSG801 - parallel, 3 armsSDTM, TA, Trial arms
Trial Elements SDTM_TE_LCSG801TE domain for an example study CSG801 - parallel, 3 armsSDTM, TE, Trial Elements
Trial Inclusion/Exclusion Criteria SDTM_TI_LCSG801TI domain for an example study CSG801SDTM, TI, Trial Inclusion/Exclusion Criteria
Tumor/Lesion Results SDTM_TR_LONCEX06Tumor/Lesion Results - Investigator tumor identification, tumor results and response data using RECIST 1.1Clinical SAS, Oncology domains, SDTM
Tumor/Lesion Identification SDTM_TU_L101Tumor/Lesion Identification
Tumor/Lesion Identification SDTM_TU_LONCEX06Tumor/Lesion Identification - Investigator tumor identification, tumor results and response data using RECIST 1.1Clinical SAS, Oncology domains, SDTM
Trial Visits SDTM_TV_LCSG801TV domain for an example study CSG801 - parallel, 3 armsSDTM, TV, Trial visits
Vital Signs SDTM_VS_LCSG001Vital Signs Programming for study CSG001VS,Vital Signs
Baseline TASKS_BL_L101Derivation of baseline flag in SDTM VS dataset - single subject single testBaseline, Baseline flag, SDTM, Vital Signs, VSBLFL, FIRST., LAST.
Baseline TASKS_BL_L102Derivation of baseline flag in SDTM VS dataset - with VSTPT -single subject single testBaseline, Baseline flag, SDTM, Vital Signs, VSTPT, PRE-DOSE, VSBLFL, LAST.
Baseline TASKS_BL_L103Derivation of baseline flag in SDTM VS dataset - with VSPOS -single subject single testBaseline, Baseline flag, SDTM, Vital Signs, VSBLFL, FIRST., LAST.
Baseline TASKS_BL_L104Derivation of baseline flag in SDTM LB dataset - with LBCAT -single subjectBaseline, Baseline flag, SDTM, Laboratory Test Results, LBCAT, LBBLFL, FIRST.
Baseline TASKS_BL_L105Derivation of baseline flag in SDTM OE dataset - with OELAT -single subjectBaseline, Baseline flag, SDTM, Ophthalmic examination, OECAT, OEBLFL, FIRST.
Baseline TASKS_BL_L106Derivation of baseline flag in SDTM MK dataset - with MKLOC and MKLAT -single subject two testsBaseline, Baseline flag, SDTM, Musculoskeletal System Findings, MKLOC, MKLAT, MKBLFL, FIRST.
Baseline TASKS_BL_L107Derivation of baseline flag in SDTM MB dataset - with MBTSTDTL -single subject single testBaseline, Baseline flag, SDTM, Microbiology Specimen, MBTSTDTL, MBBLFL, FIRST.
How I solved it? TASKS_HIS_L1001Identify the overlap of dates in exposure intervalsDates overlap
How I solved it? TASKS_HIS_L1002Extract the last two characters from the values of a character variable
How I solved? TASKS_HIS_L1003Get the latest transfusion date on or before each lab collection date
How I solved it? TASKS_HIS_L1004Last dosing date before an adverse event start date
How I solved it? TASKS_HIS_L1005Check if an element start date is same as previous element end date in SE
How I solved it? TASKS_HIS_L1006Change from previous non-missing result
How I solved it? TASKS_HIS_L1007Filter all records of subjects with a duplicate record in ADSL
How I solved it? TASKS_HIS_L1008Compare a table output dataset after removing spaces
How I solved it? TASKS_HIS_L1009Check if at least one dose of a concomitant medication is taken within study treatment period
Lab: Laboratory data concepts TASKS_Lab_L101Derivation of eGFR using Serum Creatinine value using various methodseGFR,estimated Glomerular Filtration Rate, CKD-EPI
Lab: Laboratory data concepts TASKS_Lab_L102Derivation of Creatinine Clearance using Serum Creatinine value using various methodsCreatinine Clearance,CrCL,Cockcroft-Gault, Adjustment for body surface area
Lab: Laboratory data concepts TASKS_Lab_L103Derivation of Corrected Calcium using Calcium and Albumin resultCalcium, Albumin, Corrected Calcium, Units Conversion, Derived TESTCD
Lab: Laboratory data concepts TASKS_Lab_L201Derivation of CTCAE V5 Grades - HGB - Hemoglobin- AnemiaCTCAE V5, Anemia, Toxicity grade programming, HGB, HEMOGLOBIN
Lab: Laboratory data concepts TASKS_Lab_L202Derivation of CTCAE V5 Grades - HGB - Hemoglobin - Hemoglobin increasedCTCAE V5, Hemoglobin increased, Toxicity grade programming, HGB, HEMOGLOBIN
Lab: Laboratory data concepts TASKS_Lab_L203Derivation of CTCAE V5 Grades - ALB - Albumin - HypoalbuminemiaCTCAE V5, Albumin, Toxicity grade programming, ALB, Decreased Albumin, Hypoalbuminemia
Lab: Laboratory data concepts TASKS_Lab_L204Derivation of CTCAE V5 Grades - APTT - Activated partial thromboplastin time - Increased APTT - Activated partial thromboplastin time prolongedCTCAE V5, Toxicity grade programming, APTT, Activated partial thromboplastin time, Increased APTT, Activated partial thromboplastin time prolonged
Lab: Laboratory data concepts TASKS_Lab_L205Derivation of CTCAE V5 Grades - BILI - Blood Bilirubin - Increased Bilirubin - Blood bilirubin increasedCTCAE V5, Toxicity grade programming, BILI , Blood Bilirubin , Increased Bilirubin , Blood bilirubin increased
Lab: Laboratory data concepts TASKS_Lab_L206Derivation of CTCAE V5 Grades - ALT - Alanine aminotransferase increasedCTCAE V5, Toxicity grade programming, ALT , Alanine aminotransferase increased
Lab: Laboratory data concepts TASKS_Lab_L207Derivation of CTCAE V5 Grades - AST - Aspartate aminotransferase increasedCTCAE V5, Toxicity grade programming, AST , Aspartate aminotransferase increased
Lab: Laboratory data concepts TASKS_Lab_L208Derivation of CTCAE V5 Grades - ALP - Alkaline phosphatase increasedCTCAE V5, Toxicity grade programming, ALP , Alkaline phosphatase increased
Lab: Laboratory data concepts TASKS_Lab_L209Derivation of CTCAE V5 Grades - GLUC - Glucose decreased - HypoglycemiaCTCAE V5, Toxicity grade programming, GLUC , Glucose decreased , Hypoglycemia
Lab: Laboratory data concepts TASKS_Lab_L210Derivation of CTCAE V5 Grades - SODIUM - Sodium decreased - HyponatremiaCTCAE V5, Toxicity grade programming, SODIUM , Sodium decreased , Hyponatremia
Lab: Laboratory data concepts TASKS_Lab_L211Derivation of CTCAE V5 Grades - SODIUM - Sodium increased - HypernatremiaCTCAE V5, Toxicity grade programming, SODIUM , Sodium increased , Hypernatremia
Lab: Laboratory data concepts TASKS_Lab_L212Derivation of CTCAE V5 Grades - K - Potassium decreased - HypokalemiaCTCAE V5, Toxicity grade programming, K , Potassium decreased , Hypokalemia
Lab: Laboratory data concepts TASKS_Lab_L213Derivation of CTCAE V5 Grades - K - Potassium increased - HyperkalemiaCTCAE V5, Toxicity grade programming, K , Potassium increased , Hyperkalemia
Lab: Laboratory data concepts TASKS_Lab_L214Derivation of CTCAE V5 Grades - MG - Magnesium decreased - HypomagnesemiaCTCAE V5, Toxicity grade programming, MG , Magnesium decreased , Hypomagnesemia
Lab: Laboratory data concepts TASKS_Lab_L215Derivation of CTCAE V5 Grades - MG - Magnesium increased - HypermagnesemiaCTCAE V5, Toxicity grade programming, MG , Magnesium increased , Hypermagnesemia
Lab: Laboratory data concepts TASKS_Lab_L216Derivation of CTCAE V5 Grades - CA - Calcium decreased - HypocalcemiaCTCAE V5, Toxicity grade programming, CA , Calcium decreased , Hypocalcemia
Lab: Laboratory data concepts TASKS_Lab_L217Derivation of CTCAE V5 Grades - CA - Calcium increased - HypercalcemiaCTCAE V5, Toxicity grade programming, CA , Calcium increased , Hypercalcemia
Lab: Laboratory data concepts TASKS_Lab_L218Derivation of CTCAE V5 Grades - CPK - Creatine phosphokinase increased - CPK increasedCTCAE V5, Toxicity grade programming, CPK , Creatine phosphokinase increased , CPK increased
Lab: Laboratory data concepts TASKS_Lab_L219Derivation of CTCAE V5 Grades - LIPASE - Lipase increasedCTCAE V5, Toxicity grade programming, LIPASE , Lipase increased
Lab: Laboratory data concepts TASKS_Lab_L220Derivation of CTCAE V5 Grades - AMYLASE - Serum amylase increasedCTCAE V5, Toxicity grade programming, AMYLASE , Serum amylase increased
Lab: Laboratory data concepts TASKS_Lab_L221Derivation of CTCAE V5 Grades - CHOL - Cholesterol increased - Cholesterol highCTCAE V5, Toxicity grade programming, CHOL , Cholesterol increased, Cholesterol high
Lab: Laboratory data concepts TASKS_Lab_L222Derivation of CTCAE V5 Grades - CREAT - Creatinine increasedCTCAE V5, Toxicity grade programming, CREAT , Creatinine increased
Lab: Laboratory data concepts TASKS_Lab_L223Derivation of CTCAE V5 Grades - FIBRINO - Fibrinogen decreasedCTCAE V5, Toxicity grade programming, FIBRINO , Fibrinogen decreased
Lab: Laboratory data concepts TASKS_Lab_L224Derivation of CTCAE V5 Grades - GGT - Gamma-GlutamylTransferase - GGT increasedCTCAE V5, Toxicity grade programming, GGT , Gamma-GlutamylTransferase , GGT increased
Lab: Laboratory data concepts TASKS_Lab_L225Derivation of CTCAE V5 Grades - LYM - Lymphocyte count decreasedCTCAE V5, Toxicity grade programming, LYM , Lymphocyte count decreased
Lab: Laboratory data concepts TASKS_Lab_L226Derivation of CTCAE V5 Grades - LYM - Lymphocyte count increasedCTCAE V5, Toxicity grade programming, LYM , Lymphocyte count increased
Lab: Laboratory data concepts TASKS_Lab_L227Derivation of CTCAE V5 Grades - NEUT - Neutrophil count decreasedCTCAE V5, Toxicity grade programming, NEUT , Neutrophil count decreased
Lab: Laboratory data concepts TASKS_Lab_L228Derivation of CTCAE V5 Grades - PLAT - Platelet count decreasedCTCAE V5, Toxicity grade programming, PLAT , Platelet count decreased
Lab: Laboratory data concepts TASKS_Lab_L229Derivation of CTCAE V5 Grades - WBC - White blood cell decreasedCTCAE V5, Toxicity grade programming, WBC , White blood cell decreased
Lab: Laboratory data concepts TASKS_Lab_L230Derivation of CTCAE V5 Grades - WBC - White blood cell increased - LeukocytosisCTCAE V5, Toxicity grade programming, WBC , White blood cell increased , Leukocytosis
Oncology: SDTM and ADaM related programming tasks TASKS_ONCO_L330ADaM - Analysis Flag for Last Evaluable VisitOncology, Oncology clinical trials,Last Evaluable Assessment
Oncology: SDTM and ADaM related programming tasks TASKS_ONCO_L331ADaM - Analysis Flag for First ResponseOncology, Oncology clinical trials,Last Evaluable Assessment
Oncology: SDTM and ADaM related programming tasks TASKS_ONCO_L332ADaM - Analysis Flag for First Progressive DiseaseOncology, Oncology clinical trials,Last Evaluable Assessment
Oncology: SDTM and ADaM related programming tasks TASKS_ONCO_L333ADaM - Analysis Flag for Progressive Disease - handling skipped assessmentsOncology, Oncology clinical trials,First progression without skipped assessments
Oncology: SDTM and ADaM related programming tasks TASKS_ONCO_L431ADaM - BOCR parameter derivation - Best Overall Confirmed ResponseBOCR, Best overall confirmed response
SDTM General Concepts TASKS_SDTMGEN_L050Conversion of raw date values to ISO8601 formatSDTM, ISO8601 date, dates conversion
SDTM General Concepts TASKS_SDTMGEN_L070aSDTM DM dataset RFPENDTC programming - manual approachSDTM, DM, RFPENDTC
SDTM General Concepts TASKS_SDTMGEN_L070a1SDTM DM dataset RFPENDTC programming - dynamic approachLatest date from all raw date variables
SDTM General Concepts TASKS_SDTMGEN_L071SDTM DM dataset - create planned arm variablesSDTM, DM, Demographics, ARMCD, ARM, Planned arm, description of planned arm
SDTM General Concepts TASKS_SDTMGEN_L072SDTM DM dataset - create actual arm variablesSDTM, DM, ACTARMCD, ACTARM, Actual arm
SDTM General Concepts TASKS_SDTMGEN_L073SDTM DM dataset - RFXSTDTC and RFXENDTCSDTM, DM, RFXSTDTC, RFXENDTC
SDTM General Concepts TASKS_SDTMGEN_L074SDTM DM dataset - RFICDTC, RFSTDTC and RFENDTCSDTM, DM, RFICDTC, RFSTDTC, RFENDTC
SDTM General Concepts TASKS_SDTMGEN_L075SDTM DM dataset - DTHFL and DTHDTCDTHDTC, DTHFL
SDTM General Concepts TASKS_SDTMGEN_L101Study Day Derivation in SDTM datasets - using SDTM VS as an exampleSDTM, General Programming Concepts, Study day, VS, VSDY
SDTM General Concepts TASKS_SDTMGEN_L108Creating tests as rows from variables - wide to long transformation
SDTM General Concepts TASKS_SDTMGEN_L109Remap unscheduled visits using SV datasetVisit remapping, unscheduled visits
SDTM General Concepts TASKS_SDTMGEN_L110Creation of EPOCH variable based on date
SDTM General Concepts TASKS_SDTMGEN_L110aCreation of EPOCH variable based on date - with partial datesEPOCH
SDTM General Concepts TASKS_SDTMGEN_L111Creation of supplementary domainSUPP
SDTM General Concepts TASKS_SDTMGEN_L112Create sequence variableretain, sequence creation
SDTM General Concepts TASKS_SDTMGEN_L150Convert results in original units to standard unitsSDTM, Original results, Standard results
SDTM General Concepts TASKS_SDTMGEN_L160Creating split variables without word break - Comments - COVAL1, COVAL2 etcSplit, Arrays
SDTM General Concepts TASKS_SDTMGEN_L201Merge supplementary dataset to parent domainMerge
SDTM General Concepts TASKS_SDTMGEN_L221Create xpt fileproc copy, xpt
Figures: Generic TFL_FGN_LBAR101Bar Chart of SeroconversionClinical SAS Graphs, Bar chart
Figures: Generic TFL_FGN_LBOXPLOT101Box plot of change from baseline values of Hemoglobin over timeBoxplot
Figures: Generic TFL_FGN_LSCATTER101Scatter Plot of baseline vs postbaseline maximum hemoglobin valuesClinical SAS Graphs, Scatter plot using proc template
Figures: Time to Event TFL_FTTE_L101Cumulative Incidence PlotTTE, Time to event, Censor, Events, Lifetest, Cumulative incidence, proc template
Figures: Time to Event TFL_FTTE_L101aCumulative Incidence PlotTTE, Time to event, Censor, Events, Lifetest, Cumulative incidence, proc template
Figures: Time to Event TFL_FTTE_L101bCumulative Incidence PlotTTE, Time to event, Censor, Events, Lifetest, Cumulative incidence, proc template, axistable
Listings: Adverse Events TFL_LAE_L101Adverse EventsAdverse Events, SOC PT indentation using \pnhang\par\li200, {\line} for new line, split character, asis=on, protectspecialchars=off
Listings: Demographics TFL_LDM_L101Demographic CharacteristicsDemographic characteristics, baseline height, baseline weight
Listings: Disposition TFL_LDS_L101Screen FailuresScreen Failures
Listings: Disposition TFL_LDS_L102Inclusion/Exclusion From Analysis SetsAnalysis Set Inclusion/Exclusion
Listings: Disposition TFL_LDS_L103Treatment DiscontinuationTreatment Discontinuation
Listings: Disposition TFL_LDS_L104Dates of First and Last EvaluationsFirst Evaluation - RFICDT, Last Evaluation - RFPENDT
Listings: Protocol Deviations TFL_LDV_L103Protocol DeviationsProtocol deviations, deviation code, deviation subcode
Listings: ECG TFL_LEG_L101ECG ResultsECG Results
Listings: Medical History TFL_LMH_L101Medical HistoryMedical History
ODS RTF: Report formatting TFL_ODSRTF_L211Add indentation for preferred terms in AE by SOC and PT table using RTF tagli220,^w
ODS RTF: Report formatting TFL_ODSRTF_L212Present SOC values in bold font in an AE SOC and PT table using RTF tagli220,^w
ODS RTF: Report formatting TFL_ODSRTF_L213Present specific values in red font in an AE SOC and PT table using RTF tagli220,^w
ODS RTF: Report formatting TFL_ODSRTF_L214Spanning header - underline under certain treatment column groupsli220,^w
ODS RTF: Report formatting TFL_ODSRTF_L215Adding a superscript and a subscript to the data values using rtf tagli220,^w
ODS RTF: Report formatting TFL_ODSRTF_L221Present a set of columns on one page and second of columns on a second page - basic example
ODS RTF: Report formatting TFL_ODSRTF_L301Missing option on proc report statement - variables defined as 'order' variables
ODS RTF: Report formatting TFL_ODSRTF_L401Pagination : demog table like layout which contain multiple sections
Table programming - General Concepts TFL_TABGEN_L201Descriptive statistics for a single numeric variableproc summary, completetypes, preloadfmt, proc format, descriptive statistics
Table programming - General Concepts TFL_TABGEN_L202Descriptive statistics for two numeric variablesproc summary, completetypes, preloadfmt, proc format, descriptive statistics
Table programming - General Concepts TFL_TABGEN_L301Summary for categorical variables - one variable - Sexproc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx
Table programming - General Concepts TFL_TABGEN_L302Summary for categorical variables - two variables - Sex and raceproc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx
Table programming - General Concepts TFL_TABGEN_L401Demographic characteristics - 2 numeric, 2 categorical variablesproc summary, categorical variables, numeric variables, proc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx
Tables: Adverse Events TFL_TAE_L100Overview of Treatment-Emergent Adverse Events - Subject count and Event countTFL, TAE, Adverse Events, Overview, DUMMY_SHELL_CREATION, DUMMY_TREATMENT_TOTALS, Subject counts, Event counts
Tables: Adverse Events TFL_TAE_L101Treatment emergent adverse events, by primary system organ class and preferred termAE,TEAE,SOC,PT,BY SOC and PT,Adverse Events
Tables: Adverse Events TFL_TAE_L102Treatment-Emergent Adverse Events by Maximum SeverityAE,TEAE,SOC,PT,BY SOC and PT,Adverse Events,By Maximum severity
Tables: Adverse Events TFL_TAE_L103Treatment-Emergent Adverse Events by SOC and PT sorted by descending frequencyAE,TEAE,SOC,PT,BY SOC and PT,Adverse Events, By Descending Frequency
Tables: Adverse Events TFL_TAE_L103aTreatment-Emergent Adverse Events by SOC and PT sorted by descending frequency - SOC repeated on pageAE,TEAE,SOC,PT,BY SOC and PT,Adverse Events, By Descending Frequency
Tables: Adverse Events TFL_TAE_L103bTreatment-Emergent Adverse Events by SOC and PT sorted by descending frequency - SOC repeated on pageAE,TEAE,SOC,PT,BY SOC and PT,Adverse Events, By Descending Frequency,SOC Continued
Tables: Adverse Events TFL_TAE_L104Treatment-Emergent Adverse Events by Relationship to Study DrugAE,TEAE,SOC,PT,BY SOC and PT,Adverse Events,By Maximum Relationship to study drug
Tables: Adverse Events TFL_TAE_L105Treatment-Emergent Adverse Events by Preferred Term - Descending frequencyAE,TEAE,PT,BY Preferred term,Adverse Events,descending frequency
Tables: Adverse Events TFL_TAE_L105aTreatment-Emergent Adverse Events by Preferred TermAE,TEAE,PT,BY Preferred term,Adverse Events
Tables: Adverse Events TFL_TAE_L105a1Treatment-Emergent Adverse Events by Preferred Term (descending frequency)AE,TEAE,PT,BY Preferred term,Adverse Events
Tables: Adverse Events TFL_TAE_L106TEAE That Equal to or Exceed a Threshold of 5% in Any Treatment GroupAE,TEAE,SOC,PT,BY SOC and PT,Threshold,percent cutoff,5%
Tables: Adverse Events TFL_TAE_L107Treatment-Emergent Adverse Events by Preferred Term - with fisher exact test p-valueAE,TEAE,PT,BY Preferred term,Adverse Events, p-value(only for low dose vs placebo)
Tables: Adverse Events TFL_TAE_L107aTEAE by PT - with chisq/fisher exact test p-valueAE,TEAE,PT,BY Preferred term,Adverse Events, p-value,chisq,fisher,expected count
Tables: Adverse Events TFL_TAE_L108TEAE by PT - Odds RatioAE,TEAE,PT,BY Preferred term,Adverse Events, odds ratio, 95% confidence intervals, relrisk option in proc freq tables statement
Tables: Adverse Events TFL_TAE_L108aTEAE by PT - Odds Ratio with p-valueAE,TEAE,PT,BY Preferred term,Adverse Events, odds ratio, 95% confidence intervals, p-value, proc logistic, lsmeans, diff
Tables: Adverse Events TFL_TAE_L109TEAE by PT - Risk RatioAE,TEAE,PT,BY Preferred term,Adverse Events, risk ratio, 95% confidence intervals, relrisk option in proc freq tables statement
Tables: Adverse Events TFL_TAE_L110TEAE by PT - Risk DifferenceAE,TEAE,PT,BY Preferred term,Adverse Events, risk difference, 95% confidence intervals, riskdiff option in proc freq tables statement
Tables: Adverse Events TFL_TAE_L111Exposure Adjusted Treatment-Emergent Adverse Event Rate by SOC and PT sorted by descending rateTEAE,Exposure Adjusted Event Rate, Subject-years, Event counts,
Tables: Adverse Events TFL_TAE_L112Exposure Adjusted Treatment-Emergent Adverse Subject Incidence Rate by SOC and PT sorted by descending rateTEAE;Exposure Adjusted Event Rate; Subject-years; Event counts;
Tables: Adverse Events TFL_TAE_L113TEAE by SOC, PT and GradeAETOXGR, Toxicity Grade, CTCAE
Tables: Concomitant Medications TFL_TCM_L101Concomitant MedicationsCM,ATC classification,ATC2,ATC4,CMDECOD,Concomitant Medication, 3 Levels, Subject counts
Tables: Concomitant Medications TFL_TCM_L102Concomitant Medications by preferred termCM,CMDECOD,Concomitant Medication, Subject counts, Descending frequency
Tables: Demographics and Baseline Characteristics TFL_TDM_L100Demographic Characteristics - without using macrosproc summary, categorical variables, numeric variables, proc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx
Tables: Demographics and Baseline Characteristics TFL_TDM_L101Demographic CharacteristicsDM, Demographics, Baseline Characteristics, Counts macro, Descriptive macro, Sex, Age, Race, Height, Weight, BMi
Tables: Disposition TFL_TDS_L101Summary of Analysis Sets
Tables: Disposition TFL_TDS_L102Treatment DispositionTreatment disposition, nway, completetypes, preloadfmt
Tables: Disposition TFL_TDS_L102aTreatment Disposition - coding approach 2Treatment disposition, dummy shell creation
Tables: ECG TFL_TEG_L101Interpretation of ECG ResultsEG,ECG,Abnormality, Interpretation,Modified Denom,Dummy creation,Subject counts
Tables: ECG TFL_TEG_L102ECG Results: Result and Change From BaselineEG, ECG, Result and Change from baseline, By visit, Param as page header, stats as columns, Complex Report logic
Tables: ECG TFL_TEG_L103Categorized Absolute Value in QTcB - Non-exclusive categories - Multiple CRIT variablesEG,ECG,QTC Abnormality, Modified Denom,Dummy creation,Subject counts
Tables: ECG TFL_TEG_L104Categorized Absolute Value in QTcB - Exclusive categories - AVALCAT1EG,ECG,QTC Result Categorization, Modified Denom,Dummy creation,Subject counts
Tables: ECG TFL_TEG_L105Categorized Change from Baseline in QTcB ? Non-exclusive categories - Multiple CRITEG,ECG,QTC Abnormality, Modified Denom,Dummy creation,Subject counts
Tables: ECG TFL_TEG_L106Shift Table for ECG InterpretationEG,ECG,Abnormality, Interpretation,Shift Table
Tables: ECG TFL_TEG_L106aShift Table for ECG Interpretation - Including Missing RowEG,ECG,Abnormality, Interpretation,Shift Table
Tables: ECG TFL_TEG_L106bShift Table for ECG Interpretation - with treatment and postbaseline results as rowsEG,ECG,Abnormality, Interpretation,Shift Table
Tables: Exposure TFL_TEX_L101Study Drug Exposureproc summary, categorical variables, numeric variables, proc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx
Tables: Inferential Statistics TFL_TIS_L101Fisher's exact : Comparison of proportions - Adverse EventsComparsion of proportions, Fisher's exact, p-value
Tables: Inferential Statistics TFL_TIS_L111Chi-Square: Comparison of proportions - DemographicsComparsion of proportions, Chi-square, Demographics
Tables: Inferential Statistics TFL_TIS_L121ANOVA: Comparison of means - DemographicsComparsion of means, ANOVA, Demographics
Tables: Inferential Statistics TFL_TIS_L131Binomial Test: Inference about a proportion - Responder analysisExact Binomial, Confidence intervals, 95% CI
Tables: Inferential Statistics TFL_TIS_L141Odds Ratio: Simple Logistic Regression - Responder AnalysisOdds ratio, wald, logistic regression, responder analysis, 95% confidence interval
Tables: Inferential Statistics TFL_TIS_L151ANCOVA: Change from baseline analysisANCOVA, Change from baseline, HBA1C, COVARIATE
Tables: Inferential Statistics TFL_TIS_LTTEST101One-Sample t-Test - analysis of BMIInferential statistics, one sample t-test in sas
Tables: Laboratory Results Analsysis TFL_TLB_L101Actual Value and Change from Baseline for Laboratory Tests by VisitTFL,LB,Descriptive stats,Auto-decimal,Auto-rounding, By visit, RTF underline, RTF dummy column, RTF indentation
Tables: Laboratory Results Analsysis TFL_TLB_L102Descriptive statistics Actual Value and Change from Day 1 during each cycleTFL,LB,Descriptive stats,Change from Day 1,Auto-decimal,Auto-rounding, By visit, RTF underline, RTF dummy column, RTF indentation
Tables: Laboratory TFL_TLB_L103Shift Table for Laboratory Test ResultsLB, Laboratory analysis, shift table, low, normal, high, missing, no data, Modified denoms, Dummy creation
Tables: Laboratory TFL_TLB_L104Summary Shifts in Laboratory Test ResultsLB, Laboratory analysis, Sumary shifts table, low, normal, high, missing, no data, Modified denoms,at-risk denoms,'at risk', Dummy creation
Tables: Laboratory TFL_TLB_L105Shift from Baseline to Worst Value Post-Baseline in Terms of CTCAE GradesLaboratory, shift, CTCAE
Tables: Laboratory TFL_TLB_L106Shifts in Laboratory Test Results in terms of CTCAE GradesLaboratory,shift,CTCAE,ATOXGR,BTOXGR
Tables: Medical History TFL_TMH_L101Medical History by SOC and PTMH,SOC,PT,BY SOC and PT,Medical History,Subject counts
Tables: Response Analysis TFL_TRS_L103Response Analysis: Concordance between IRC and Investigator Best Response AnalysisADRS, Tumor Response Evaluation, Concordance
Tables: Time to Event TFL_TTTE_L101Overall Survival by Treatment GroupTTE, Time to event, Censor, Events, Lifetest, Quartiles, 95 % Ci
Tables: Time to Event TFL_TTTE_L101aOverall Survival by Treatment GroupTTE, Time to event, Censor, Events, Lifetest, Quartiles, 95 % Ci
Tables: Time to Event TFL_TTTE_L101bOverall Survival by Treatment GroupTTE, Time to event, Censor, Events, Lifetest, Quartiles, 95 % Ci, PHREG, Hazard ratio
Tables: Vital Signs TFL_TVS_L101Vital Signs: Result and Change From BaselineVS, Vital Signs, Result and Change from baseline, By visit, Decimal precision, Param as page header, stats as columns, Complex Report
Tables: Vital Signs TFL_TVS_L101aVital Signs: Result and Change From BaselineVital signs, Result and Change from Baseline
Tables: Vital Signs TFL_TVS_L102Potentially Clinically Significant Vital SignsVS, Vital Signs, Potentially Clinically Significant Vital Signs, n/m,ncount,mcount, Modified denom