Concept |
Lesson |
Lesson Title |
Keywords |
Full ADSL - Subject Level Analysis Dataset | ADaM_ADSL_L1101 | ADSL dataset for a parallel arm study - MYCSG-001 | CDISC, ADaM, ADSL, Complete program |
Full ADAE - Adverse Events Analysis Dataset | ADaM_ADAE_L1101 | ADAE dataset for a parallel arm study - MYCSG-001 | ADaM, ADAE, Adverse Events, TRTMFL, APHASE, PREFL, FUPFL |
Full ADCM - Concomitant Medication Analysis Dataset | ADaM_ADCM_L1101 | ADCM dataset for a parallel arm study - MYCSG-001 | ADaM, ADCM, Concomitant Medications |
Full ADCM - Concomitant Medication Analysis Dataset | ADaM_ADCM_LCMSUM01 | ADCM summary dataset in a diabetes study | ADCMSUM, ADaM, Rescue medication summary |
Full ADEXSUM - Exposure Summary Analysis Dataset | ADaM_ADEXSUM_L1101 | ADEXSUM dataset for a parallel arm study - MYCSG-001 | ADaM, ADaM Other, ADEXSUM |
Full ADEG - ECG Analysis Dataset | ADaM_ADEG_L1101 | ADEG dataset in a parallel arm study | ADaM, BDS, ADEG, ECG Analysis Dataset, CDISC |
Full ADIS - Immunogenicity Analysis Dataset | ADaM_ADIS_LVAC01 | ADIS - Immune response in a vaccine study - 001 | Clinical Programming, ADaM, ADIS, Immunogenicity |
Full ADPC - Pharmacokientic Concentrations | ADaM_ADPC_LOD101 | Analysis Dataset for Pharmacokientic Concentrations - Oral dosing 101 | ADaM, ADPC, Pharamacokinetic concentrations |
Full ADQS - Questionnaire Analysis Dataset | ADaM_ADQS_L1101 | ADQSEQ5D dataset for a parallel arm study - MYCSG-001 | ADaM, BDS, ADQS, EQ5D-5L |
Full ADQS - Questionnaire Analysis Dataset | ADaM_ADQS_LEASI01 | ADQSEASI - Eczema Area and Severity Index | ADaM, BDS, ADQS, EASI |
Full ADRS - Response Analysis Dataset | ADaM_ADRS_L1101 | ADRS dataset - Best overall response | ADRS, Oncology, Best overall response, BESTRESP |
Full ADVS - Vital Signs Analysis Dataset | ADaM_ADVS_L1101 | ADVS dataset for a parallel arm study - MYCSG-001 | ADaM, BDS, ADVS, Vital Signs Analysis Dataset, CDISC |
Full Other BDS - Other BDS datasets | ADaM_BDS_LADICE01 | Analysis Dataset for Intercurrent Events | ADaM, Intercurrent Events |
Subject Level Analysis Data | ADaM_C1001_L101 | Derivation of key date variables which are commonly used on ADSL | ADaM,ADSL,Key dates, RFICDT, RANDDT, TRTSDT, TRTEDT, FVISDT, LVISDT |
Subject Level Analysis Data | ADaM_C1001_L102 | Derivation of subject level population flags which are commonly used in ADSL | ADaM SCRFFL RANDFL SAFFL FASFL PPROTFL |
Subject Level Analysis Data | ADaM_C1001_L102a | Safety flag ? special case using Drug accountability and Exposure datasets | ADaM,TRTSDT,TRTEDT,SAFFL,SAF2FL |
Subject Level Analysis Data | ADaM_C1001_L103 | Different Treatment related variables - Parallel group study | ADaM,ADSL,Treatment Group, TRT01P, TRT01A |
Subject Level Analysis Data | ADaM_C1001_L103a | Different Treatment related variables - Two period cross-over study | ADaM,ADSL,Treatment variables,Cross over study |
Subject Level Analysis Data | ADaM_C1001_L103b | Different Treatment grouping variables ? Parallel group study | ADaM,ADSL,Pooled Treatment Group, TR01PG1, TR01AG1 |
Subject Level Analysis Data | ADaM_C1001_L104 | Creation of baseline variables: HEIGHTBL and WEIGHTBL | ADaM,ADSL,Baseline, Baseline variables, HEIGHTBL, WEIGHTBL, TRANSPOSE, LAST. |
Subject Level Analysis Data | ADaM_C1001_L105 | Creation of grouping variables: both character and numeric variables | ADaM, ADSL, AGEGRy, SITEGRy, BMIGRy, FREQ |
Subject Level Analysis Data | ADaM_C1001_L106 | Derivation of variables related to end of treatment and end of study | ADaM, ADSL, EOTSTT, EOTDT, DCTREAS, EOSSTT, EOSDT, DCSREAS |
Dates and Date imputations | ADaM_C1002_L101 | Conversion of character dates of ISO 8601 to numeric date, time and date time values | Numeric dates, ASTDT, ASTTM, ASTDTM |
Dates and Date imputations | ADaM_C1002_L102 | Imputation of missing date components: 01 for missing day, JAN for missing month | Dates imputation,Imputation flag, ASTDT, ASTDTF |
Dates and Date imputations | ADaM_C1002_L102a | Imputation 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_L103 | Imputation of missing date components: based on treaatment start date of the subject | Dates imputation ,Imputation flag, ASTDT, ASTDTF |
Treament emergence, pre and post treatment occurrences | ADaM_C1003_L101 | Adverse Event Treatment Emergence Flag - basic example | TRTEMFL |
Treament emergence, pre and post treatment occurrences | ADaM_C1003_L102 | Adverse Event Treatment Emergence Flag - considering the baseline severity | TRTEMFL |
Treament emergence, pre and post treatment occurrences | ADaM_C1003_L102a | Adverse Event Treatment Emergence Flag - considering the baseline severity and cutoff after treatment end date | TRTEMFL |
Treament emergence, pre and post treatment occurrences | ADaM_C1003_L103 | Treatment Emergent Adverse Event Flag in crossover study | TRTEMFL Crossover study Analysis periods |
Treament emergence, pre and post treatment occurrences | ADaM_C1003_L103a | Treatment Emergent Adverse Event Flag in crossover study, separate flag for each period | TRTEMFL Crossover study Analysis periods |
ADaM BDS Derived Parameters Creation | ADaM_C1004_L101 | Creation 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_L102 | Creation 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_L103 | Creation 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_L103a | Creation 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_L103b | Creation 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_L103c | Creation 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_L101 | Creation of new records to hold the minimum value across postbaseline record | ADaM, BDS, Derived records, DTYPE, MINIMUM POSTBASELINE |
ADaM BDS - Derived records creation | ADaM_C1005_L101a | Creation of new records to hold the maximum value across postbaseline record | ADaM, BDS, Derived records, DTYPE, MAXIMUM POSTBASELINE |
ADaM BDS - Derived records creation | ADaM_C1005_L101b | Creation of new records to hold the minimum and maximum values across postbaseline period | ADaM, BDS, Derived records, DTYPE, MINIMUM POSTBASELINE, MAXIMUM POSTBASELINE |
ADaM BDS - Derived records creation | ADaM_C1005_L102 | Creation of a new record, as average of all postbaseline values of a parameter | ADaM, BDS, Derived records, DTYPE, AVERAGE POSTBASELINE |
ADaM BDS - Derived records creation | ADaM_C1005_L103 | Creation of a new record, as average of triplicate measurements of QTcB | ADaM, BDS, DTYPE, Average of triplicate measurements, ECG, QTCB |
ADaM BDS - Baseline Concepts | ADaM_C1006_L101 | Creation of baseline flag, last record on or prior to treatment start | ADaM, BDS, Baseline flag, ABLFL |
ADaM BDS - Baseline Concepts | ADaM_C1006_L101a | Creation of baseline flag, base, chg and pchg variables | ADaM, BDS, Baseline flag, ABLFL,BASE,CHG,PCHG |
ADaM BDS - Baseline Concepts | ADaM_C1006_L102 | Creation of baseline flag and related variables using the concept of MINIMUM basetype | ADaM, BDS, Baseline flag,Minimum pretreatment value as baseline, ABLFL,BASE,CHG,PCHG |
ADaM BDS - Baseline Concepts | ADaM_C1006_L102a | Creation of Baseline flag and related variables using the concept of MAXIMUM basetype | ADaM, BDS, Baseline flag,Maximum pretreatment value as baseline, ABLFL,BASE,CHG,PCHG |
ADaM BDS - Baseline Concepts | ADaM_C1006_L102b | Creation 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_L102c | Creation 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_L102d | Creation 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_L101 | Creation of visit windowing based on ADY and prespecified intervals - parameter invariant | ADaM, BDS, Visit Windowing, AWTARGET, AWLO, AWHI, AVISIT |
ADaM BDS - Visit Windowing | ADaM_C1007_L102 | Creation of visit windowing based on ADY and prespecified intervals - parameter variant | ADaM, BDS, Visit Windowing, AWTARGET, AWLO, AWHI, AVISIT |
Record level treatment variables | ADaM_C1008_L101 | Actual Treatment in Adverse Events dataset in a 3 period crossover study | TRTA, TRTP, APERIOD, Record level treatment variables |
ADaM BDS - Analysis Flags | ADaM_C1009_L101 | Creation of ANL01FL, multiple record within an analysis visit. Closest and earliest record will be chosen | ADaM, BDS, Visit Windowing, Analysis Flags, ANL01FL |
ADaM BDS - Analysis Flags | ADaM_C1009_L102 | Creation of ANL01FL, multiple record within an analysis visit. Closest and latest record will be chosen | ADaM, BDS, Visit Windowing, Analysis Flags, ANL01FL |
ADaM BDS - Analysis Flags | ADaM_C1009_L103 | Creation of ANL01FL, multiple record at a timepoint, average result for analysis | ADaM, BDS, Analysis Flags, ANL01FL, DTYPE |
ADaM BDS - Analysis Flags | ADaM_C1009_L104 | Creation of ANL02FL, to identify postbaseline records - date alone | ADaM BDS, Analysis Flags, ANL02FL, Postbaseline analysis records |
ADaM BDS - Analysis Flags | ADaM_C1009_L105 | Creation of ANL03FL, to identify subjects with an abnormal postbaseline shift - ADEG | ADaM, BDS, Analysis Flags, Abnormal result, Shift |
ADaM BDS - Analysis Flags | ADaM_C1009_L106 | ADLB - Creation of Analysis flags to identify worst postbaseline toxicity grades | ADaM, BDS, Analysis Flags, ANL04FL, ANL05FL |
ADaM BDS - Data Imputation | ADaM_C1010_L101 | LOCF-Record present, result missing - using analysis visits-single parameter | ADaM, BDS, Imputation, LOCF |
ADaM BDS - Data Imputation | ADaM_C1010_L102 | LOCF-Records missing - using analysis visits-single parameter | ADaM, BDS, Imputation, LOCF, Record absent |
ADaM BDS - Data Imputation | ADaM_C1010_L103 | LOCF-Records missing - using analysis visits-multiple parameters, with different parameters having different visit schedules | ADaM, BDS, Imputation, LOCF, Record absent, Varied Schedule of assessments |
ADaM BDS - Data Imputation | ADaM_C1010_L103a | LOCF-Records missing - using analysis visits-multiple parameters, with different parameters having different visit schedules, postbaseline visits only | ADaM, BDS, Imputation, LOCF, Record absent, Varied Schedule of assessments |
ADaM BDS - Data Imputation | ADaM_C1010_L111 | BLOCF-Record present, result missing - using analysis visits-single parameter | ADaM, BDS, Imputation, BLOCF |
ADaM BDS - Criteria Flags | ADaM_C1011_L101 | Single parameter- aval based criteria-populating variables only on the records where conditions are met-single parameter | ADaM, BDS, Criteria Flags, CRIT1, CRIT1FL |
ADaM BDS - Criteria Flags | ADaM_C1011_L101a | Single parameter- aval based criteria-crit on all rows, flag on met records- single parameter | ADaM, BDS, Criteria Flags, CRIT1, CRIT1FL |
ADaM BDS - Criteria Flags | ADaM_C1011_L101b | Multiple parameters- aval based criteria-crit on all rows, flag on met records | ADaM, BDS, Criteria Flags, CRIT1, CRIT1FL |
ADaM BDS - Criteria Flags | ADaM_C1011_L101c | Single parameter- aval and chg based criteria-crit on all rows, flag on met records | ADaM, BDS, Criteria Flags, CRIT1, CRIT1FL |
ADaM BDS - Criteria Flags | ADaM_C1011_L101d | Multiple parameters- multiple criteria - aval and chg based criteria-crit on all rows, flag on met records | ADaM, BDS, Criteria Flags, CRIT1, CRIT1FL, CRIT2, CRIT2FL |
ADaM BDS - Criteria Flags | ADaM_C1011_L201 | ADLB - Multi-Response Criterion flags - For toxicity grade increase of Alanine Amino Transferase | ADaM, BDS, Criteria Flags, Multi-response criteria flags |
ADaM BDS - Shift variables | ADaM_C1012_L101 | ADLB - Shift from baseline - Normal Range Indicator (ANRIND, BNRIND) | ADaM, BDS, Shift from baseline, Normal range indicator |
ADaM BDS - Shift variables | ADaM_C1012_L102 | ADLB - Shift from baseline - Toxicity Grade (ATOXGR, BTOXGR) | ADaM, BDS, Shift from baseline, Toxicity Grade |
Time to event related variables | ADaM_C1013_L101 | Time to first rescue medication | AVAL,CNSR,Time to Event, Censor |
Time to event related variables | ADaM_C1013_L102 | Overall Survival - Time to Death - With Event Description | ADaM, BDS, TTE, Overall Survival, Time to Death, Event Description |
Time to event related variables | ADaM_C1013_L103 | Overall Survival - Time to Death - Multiple Values for Censoring | ADaM, BDS, TTE, Overall Survival, Time to Death, Event Description |
OCCDS specific variables | ADaM_C1016_L101 | AOCCFL,AOCCSFL and AOCCPFL in Adverse Events | First Occurrence Flags, AOCCFL, AOCCSFL, AOCCPFL |
| ADaM_TEST998_TEST998a | | |
| ADaM_TEST998_TEST998b | This is full title | |
Macros for ADaM programming | MACROS_ADaM_L110 | Create numeric date/time variables from SDTM ISO DTC variables | Macros, numeric dates |
Macros for ADaM programming | MACROS_ADaM_L120 | Create study day variable in ADaM datasets | Study day |
Macros for ADaM programming | MACROS_ADaM_L130 | Create baseline flag and related variables - ABLFL, BASE, BASEC ... | ABLFL, BASE, BASEC |
Macros for General programming | MACROS_GEN_L210 | Import multiple sheets from a single excel file | Proc import macro |
Macros for General programming | MACROS_GEN_L310 | Run same code on multiple datasets - data step | SAS clinical macros |
Macros for General programming | MACROS_GEN_L311 | Run proc sort on multiple datasets - same by variables | SAS clinical macros |
Macros for General programming | MACROS_GEN_L312 | Run proc freq on multiple datasets - one or more tables | SAS clinical macros |
Macros for General programming | MACROS_GEN_L313 | Run proc sort nodupkey on multile datasets using same by variables | SAS clinical macros |
Macros for General programming | MACROS_GEN_L314 | Run proc sort NOuniquekeys on multile datasets using same by variables | SAS clinical macros |
Macros for General programming | MACROS_GEN_L401 | Create new folder on harddrive from a sas program | SAS clinical macros |
Macros for General programming | MACROS_GEN_L402 | Get the file details in a folder/subfolders - OS specific commands | SAS clinical macros |
Macros for General programming | MACROS_GEN_L403 | Create/delete a temporary copy of the file for reading into SAS - OS based commands | SAS clinical macros |
Macros for SDTM programming | MACROS_SDTM_L251 | Macro to convert raw date values to ISO8601 format | SDTM,Macros,IS08601 |
Macros for SDTM programming | MACROS_SDTM_L261 | Macro to create study day variable in SDTM datasets | SDTM, Macro, Study day |
Macros for SDTM programming | MACROS_SDTM_L271 | Macro to create sequence variable in SDTM datasets | SDTM, Macros, Sequence variable |
Macros for SDTM programming | MACROS_SDTM_L281 | Macro to create baseline flag in SDTM datasets | SDTM, Macro, Baseline flag |
Introduction to SAS | SAS_INTRO_L101 | Introduction to SAS | |
Reading Raw data in SAS | SAS_READRAW_L101 | Reading raw data arranged in columns | |
Reading Raw data in SAS | SAS_READRAW_L102 | Reading raw data separated by delimiters | |
Creating Data Subsets in SAS | SAS_SUBSETTING_L101 | Basics of Subsetting Observations | |
Appending Datasets in SAS | SAS_APPENDING_L101 | Appending datasets using SET statement | |
Merging Datasets in SAS | SAS_MERGING_L101 | Match Merging in SAS | |
Data Step Features in SAS | SAS_DATASTEP_L080 | Conditional Processing - Part 01 | |
Data Step Features in SAS | SAS_DATASTEP_L085 | Loops in SAS - Part 01 | |
Data Step Features in SAS | SAS_DATASTEP_L101 | Explicit Output Statement | |
Data Step Features in SAS | SAS_DATASTEP_L103 | Arrays in SAS | |
Program Data Vector in SAS | SAS_PDV_L101 | Understanding PDV in SAS | |
Functions in SAS | SAS_FUNCTIONS_L101 | Character Functions in SAS | |
Functions in SAS | SAS_FUNCTIONS_L201 | Numeric functions in SAS | |
Freq Procedure in SAS | SAS_PROCFREQ_L101 | Proc Freq Basics | |
Means Procedure in SAS | SAS_PROCMEANS_L101 | Proc Means Basics | |
Means Procedure in SAS | SAS_PROCMEANS_L102 | Understanding _FREQ_ variable of the output dataset | |
Sort Procedure in SAS | SAS_PROCSORT_L101 | Sorting of observations in a dataset | |
Sort Procedure in SAS | SAS_PROCSORT_L102 | Handling duplicate records using proc sort | |
Sort Procedure in SAS | SAS_PROCSORT_L103 | Fetching unique records using proc sort | |
Sort Procedure in SAS | SAS_PROCSORT_L104 | Understanding Sort Sequence of Character Variables | |
Import Procedure in SAS | SAS_PROCIMPORT_L101 | Proc import - Part 01 | |
Export Procedure in SAS | SAS_PROCEXPORT_L101 | Proc Export - part 01 | |
Contents Procedure in SAS | SAS_PROCCONTENTS_L101 | Proc Contents | |
Datasets Procedure in SAS | SAS_PROCDATASETS_L101 | Proc datasets - part 01 | |
Compare Procedure in SAS | SAS_PROCCOMPARE_L101 | Proc Compare - Part 01 | |
SQL Procedure in SAS | SAS_PROCSQL_L101 | SQL Procedure in SAS - Part 01 | |
Commonly Seen Log Issues in SAS | SAS_LOGISSUES_L101 | Commonly Seen Log Issues in SAS - Part 01 | |
Commonly used programming logics in clinical SAS | SAS_COMMONLOGICS_L101 | Commonly used Logics 101 | |
Adverse Events | SDTM_AE_LCSG001 | Adverse Events Programming for study CSG001 | AE,SUPPAE,Adverse Events |
Clinical Events | SDTM_CE_LGE01 | CE - Gastroenteritis | SDTM,CE,Clinical Events, Gastroenteritis |
Concomitant Medications | SDTM_CM_LCSG001 | CM dataset Programming for study CSG001 | CM, Concomitant Medications |
Cardiovascular System Findings | SDTM_CV_L101 | Cardiovascular System Findings - Echocardiogram Results | SDTM:CV, Echocardiogram results |
Drug Accountability | SDTM_DA_L101 | Drug Accountability - Dispensed and Returned Capsules | DA, Drug Accountability, DISPAMT, Dispensed Amount, RETAMT, Returned Amount |
Death Details | SDTM_DD_L101 | Death Details - date of death, autopsy, primary and secondary causes of death | SDTM DD, Death Details, AUTOPIND, PRCDTH, SECDTH |
Demographics | SDTM_DM_LCSG001 | Demographics dataset programming | SDTM,DM, Demographics |
Disposition | SDTM_DS_LCSG001 | Disposition dataset programming | SDTM,DS,Disposition, Protocol Milestones |
Protocol Deviations | SDTM_DV_L101 | Protocol Deviations - L101 | SDTM, Clinical trials programming, DV, Protocol Deviations |
Exposure as Collected | SDTM_EC_LCSG001 | EC dataset Programming for study CSG001 | EC, Exposure, Exposure as collected |
ECG Test Results | SDTM_EG_LCSG001 | ECG dataset Programming for study CSG001 | EG, ECG, Electrocardiogram |
Exposure | SDTM_EX_LCSG001 | EX dataset Programming for study CSG001 | EX, Exposure |
Findings About Events or Interventions | SDTM_FA_LGE01 | FA-Gastroenteritis | SDTM, FA, Findings About, Clinical Event, FAOBJ |
Functional Tests | SDTM_FT_L6MWT | SDTM FT dataset - 6MWT - Six Minute Walk Test | SDTM, FT, Functional Tests, 6MWT, Six Minute Walk Test |
Healthcare Encounters | SDTM_HO_L101 | Healthcare Encounters - reason, admission and discharge dates | SDTM HO, Healthcare Encounters, Admission date, discharge date, reason for admission |
Inclusion/Exclusion Criteria Not Met | SDTM_IE_L101 | Inclusion/Exclusion Criteria Not Met | SDTM IE, Inclusion/Exclusion Criteria Not Met |
Immunogenicity Specimen Assessments | SDTM_IS_LADAB | SDTM IS dataset - ADAB - Anti-Drug Antibodies | SDTM, IS, Immunogenicity Specimen Assessments, Antidrug Antibodies |
Laboratory Test Results | SDTM_LB_LCSG001 | LB dataset Programming for study CSG001 | SDTM, LB dataset programming, Chemistry, Hematology, Urinalysis |
Medical History | SDTM_MH_L201 | SDTM MH dataset - general history and cancer history | MH, Medical History, Ongoing events, partial dates |
Medical History | SDTM_MH_LCSG801 | MH dataset programming for study CSG801 | MH, Medical History, MHPRESP, Prespecified, MHOCCUR |
Morphology | SDTM_MO_L101 | Morphology - Kidney dimension using CT SCAN | SDTM MO, Morphology, Kidney morpholoy using CT SCAN |
Pharmacokinetics Concentrations | SDTM_PC_L101 | Pharmacokinetics Concentrations - Drug in plasma | SDTM, PC |
Physical Examination | SDTM_PE_L101 | Physical Examination - L101 | SDTM, PE |
Pharmacokinetics Parameters | SDTM_PP_L101 | Pharmacokinetics Parameters - Drug in plasma | SDTM,PP |
Procedures | SDTM_PR_L101 | Procedures - transfusions - date, type, volume and reason | SDTM PR, Procedures, transfusions, date and time, volume, reason for transfusion |
Questionnaires | SDTM_QS_LEQ5D3L | SDTM QS dataset - EQ5D - 3 Levels | SDTM, QS, EQ-5D-3L, European Quality of Life Five Dimension Three Level Scale |
Respiratory System Findings | SDTM_RE_L101 | Respiratory System Findings - FVC, FEV | SDTM, RE, FVC, FEV1 |
Related Records | SDTM_RELREC_L101 | SDTM RELREC dataset - Relationship creation using raw datasets | RELREC, DSAE, CMAE, SDTM |
Reproductive System Findings | SDTM_RP_L101 | Reproductive System Findings - Childbearing Potential and Menopause Status | SDTM RP, Reproductive System Findings, CHILDPOT, MENOSTAT |
Disease Response and Clin Classification | SDTM_RS_LCHPU | SDTM RS dataset - Child-Pugh Classification | SDTM, RS, Disease Response and Clin Classification, Child-Pugh Classification |
Disease Response and Clin Classification | SDTM_RS_LONCEX06 | Disease Response - Investigator tumor identification, tumor results and response data using RECIST 1.1 | Clinical SAS, Oncology domains, SDTM |
Subject Elements | SDTM_SE_LCSG001 | Subject Elements programming | SE, Subject Elements |
Substance Use | SDTM_SU_L101 | Substance Use - Alcohol, tobacco, caffeine | SDTM, SU, Alcohol, Caffeine, Tobacco |
Subject Visits | SDTM_SV_LCSG001 | Subject Visits programming | SDTM,SV,Subject Visits, Retain, Unscheduled Visits Remapping |
Trial Arms | SDTM_TA_LCSG801 | TA domain for an example study CSG801 - parallel, 3 arms | SDTM, TA, Trial arms |
Trial Elements | SDTM_TE_LCSG801 | TE domain for an example study CSG801 - parallel, 3 arms | SDTM, TE, Trial Elements |
Trial Inclusion/Exclusion Criteria | SDTM_TI_LCSG801 | TI domain for an example study CSG801 | SDTM, TI, Trial Inclusion/Exclusion Criteria |
Tumor/Lesion Results | SDTM_TR_LONCEX06 | Tumor/Lesion Results - Investigator tumor identification, tumor results and response data using RECIST 1.1 | Clinical SAS, Oncology domains, SDTM |
Tumor/Lesion Identification | SDTM_TU_L101 | Tumor/Lesion Identification | |
Tumor/Lesion Identification | SDTM_TU_LONCEX06 | Tumor/Lesion Identification - Investigator tumor identification, tumor results and response data using RECIST 1.1 | Clinical SAS, Oncology domains, SDTM |
Trial Visits | SDTM_TV_LCSG801 | TV domain for an example study CSG801 - parallel, 3 arms | SDTM, TV, Trial visits |
Vital Signs | SDTM_VS_LCSG001 | Vital Signs Programming for study CSG001 | VS,Vital Signs |
Baseline | TASKS_BL_L101 | Derivation of baseline flag in SDTM VS dataset - single subject single test | Baseline, Baseline flag, SDTM, Vital Signs, VSBLFL, FIRST., LAST. |
Baseline | TASKS_BL_L102 | Derivation of baseline flag in SDTM VS dataset - with VSTPT -single subject single test | Baseline, Baseline flag, SDTM, Vital Signs, VSTPT, PRE-DOSE, VSBLFL, LAST. |
Baseline | TASKS_BL_L103 | Derivation of baseline flag in SDTM VS dataset - with VSPOS -single subject single test | Baseline, Baseline flag, SDTM, Vital Signs, VSBLFL, FIRST., LAST. |
Baseline | TASKS_BL_L104 | Derivation of baseline flag in SDTM LB dataset - with LBCAT -single subject | Baseline, Baseline flag, SDTM, Laboratory Test Results, LBCAT, LBBLFL, FIRST. |
Baseline | TASKS_BL_L105 | Derivation of baseline flag in SDTM OE dataset - with OELAT -single subject | Baseline, Baseline flag, SDTM, Ophthalmic examination, OECAT, OEBLFL, FIRST. |
Baseline | TASKS_BL_L106 | Derivation of baseline flag in SDTM MK dataset - with MKLOC and MKLAT -single subject two tests | Baseline, Baseline flag, SDTM, Musculoskeletal System Findings, MKLOC, MKLAT, MKBLFL, FIRST. |
Baseline | TASKS_BL_L107 | Derivation of baseline flag in SDTM MB dataset - with MBTSTDTL -single subject single test | Baseline, Baseline flag, SDTM, Microbiology Specimen, MBTSTDTL, MBBLFL, FIRST. |
How I solved it? | TASKS_HIS_L1001 | Identify the overlap of dates in exposure intervals | Dates overlap |
How I solved it? | TASKS_HIS_L1002 | Extract the last two characters from the values of a character variable | |
How I solved? | TASKS_HIS_L1003 | Get the latest transfusion date on or before each lab collection date | |
How I solved it? | TASKS_HIS_L1004 | Last dosing date before an adverse event start date | |
How I solved it? | TASKS_HIS_L1005 | Check if an element start date is same as previous element end date in SE | |
How I solved it? | TASKS_HIS_L1006 | Change from previous non-missing result | |
How I solved it? | TASKS_HIS_L1007 | Filter all records of subjects with a duplicate record in ADSL | |
How I solved it? | TASKS_HIS_L1008 | Compare a table output dataset after removing spaces | |
How I solved it? | TASKS_HIS_L1009 | Check if at least one dose of a concomitant medication is taken within study treatment period | |
Lab: Laboratory data concepts | TASKS_Lab_L101 | Derivation of eGFR using Serum Creatinine value using various methods | eGFR,estimated Glomerular Filtration Rate, CKD-EPI |
Lab: Laboratory data concepts | TASKS_Lab_L102 | Derivation of Creatinine Clearance using Serum Creatinine value using various methods | Creatinine Clearance,CrCL,Cockcroft-Gault, Adjustment for body surface area |
Lab: Laboratory data concepts | TASKS_Lab_L103 | Derivation of Corrected Calcium using Calcium and Albumin result | Calcium, Albumin, Corrected Calcium, Units Conversion, Derived TESTCD |
Lab: Laboratory data concepts | TASKS_Lab_L201 | Derivation of CTCAE V5 Grades - HGB - Hemoglobin- Anemia | CTCAE V5, Anemia, Toxicity grade programming, HGB, HEMOGLOBIN |
Lab: Laboratory data concepts | TASKS_Lab_L202 | Derivation of CTCAE V5 Grades - HGB - Hemoglobin - Hemoglobin increased | CTCAE V5, Hemoglobin increased, Toxicity grade programming, HGB, HEMOGLOBIN |
Lab: Laboratory data concepts | TASKS_Lab_L203 | Derivation of CTCAE V5 Grades - ALB - Albumin - Hypoalbuminemia | CTCAE V5, Albumin, Toxicity grade programming, ALB, Decreased Albumin, Hypoalbuminemia |
Lab: Laboratory data concepts | TASKS_Lab_L204 | Derivation of CTCAE V5 Grades - APTT - Activated partial thromboplastin time - Increased APTT - Activated partial thromboplastin time prolonged | CTCAE V5, Toxicity grade programming, APTT, Activated partial thromboplastin time, Increased APTT, Activated partial thromboplastin time prolonged |
Lab: Laboratory data concepts | TASKS_Lab_L205 | Derivation of CTCAE V5 Grades - BILI - Blood Bilirubin - Increased Bilirubin - Blood bilirubin increased | CTCAE V5, Toxicity grade programming, BILI , Blood Bilirubin , Increased Bilirubin , Blood bilirubin increased |
Lab: Laboratory data concepts | TASKS_Lab_L206 | Derivation of CTCAE V5 Grades - ALT - Alanine aminotransferase increased | CTCAE V5, Toxicity grade programming, ALT , Alanine aminotransferase increased |
Lab: Laboratory data concepts | TASKS_Lab_L207 | Derivation of CTCAE V5 Grades - AST - Aspartate aminotransferase increased | CTCAE V5, Toxicity grade programming, AST , Aspartate aminotransferase increased |
Lab: Laboratory data concepts | TASKS_Lab_L208 | Derivation of CTCAE V5 Grades - ALP - Alkaline phosphatase increased | CTCAE V5, Toxicity grade programming, ALP , Alkaline phosphatase increased |
Lab: Laboratory data concepts | TASKS_Lab_L209 | Derivation of CTCAE V5 Grades - GLUC - Glucose decreased - Hypoglycemia | CTCAE V5, Toxicity grade programming, GLUC , Glucose decreased , Hypoglycemia |
Lab: Laboratory data concepts | TASKS_Lab_L210 | Derivation of CTCAE V5 Grades - SODIUM - Sodium decreased - Hyponatremia | CTCAE V5, Toxicity grade programming, SODIUM , Sodium decreased , Hyponatremia |
Lab: Laboratory data concepts | TASKS_Lab_L211 | Derivation of CTCAE V5 Grades - SODIUM - Sodium increased - Hypernatremia | CTCAE V5, Toxicity grade programming, SODIUM , Sodium increased , Hypernatremia |
Lab: Laboratory data concepts | TASKS_Lab_L212 | Derivation of CTCAE V5 Grades - K - Potassium decreased - Hypokalemia | CTCAE V5, Toxicity grade programming, K , Potassium decreased , Hypokalemia |
Lab: Laboratory data concepts | TASKS_Lab_L213 | Derivation of CTCAE V5 Grades - K - Potassium increased - Hyperkalemia | CTCAE V5, Toxicity grade programming, K , Potassium increased , Hyperkalemia |
Lab: Laboratory data concepts | TASKS_Lab_L214 | Derivation of CTCAE V5 Grades - MG - Magnesium decreased - Hypomagnesemia | CTCAE V5, Toxicity grade programming, MG , Magnesium decreased , Hypomagnesemia |
Lab: Laboratory data concepts | TASKS_Lab_L215 | Derivation of CTCAE V5 Grades - MG - Magnesium increased - Hypermagnesemia | CTCAE V5, Toxicity grade programming, MG , Magnesium increased , Hypermagnesemia |
Lab: Laboratory data concepts | TASKS_Lab_L216 | Derivation of CTCAE V5 Grades - CA - Calcium decreased - Hypocalcemia | CTCAE V5, Toxicity grade programming, CA , Calcium decreased , Hypocalcemia |
Lab: Laboratory data concepts | TASKS_Lab_L217 | Derivation of CTCAE V5 Grades - CA - Calcium increased - Hypercalcemia | CTCAE V5, Toxicity grade programming, CA , Calcium increased , Hypercalcemia |
Lab: Laboratory data concepts | TASKS_Lab_L218 | Derivation of CTCAE V5 Grades - CPK - Creatine phosphokinase increased - CPK increased | CTCAE V5, Toxicity grade programming, CPK , Creatine phosphokinase increased , CPK increased |
Lab: Laboratory data concepts | TASKS_Lab_L219 | Derivation of CTCAE V5 Grades - LIPASE - Lipase increased | CTCAE V5, Toxicity grade programming, LIPASE , Lipase increased |
Lab: Laboratory data concepts | TASKS_Lab_L220 | Derivation of CTCAE V5 Grades - AMYLASE - Serum amylase increased | CTCAE V5, Toxicity grade programming, AMYLASE , Serum amylase increased |
Lab: Laboratory data concepts | TASKS_Lab_L221 | Derivation of CTCAE V5 Grades - CHOL - Cholesterol increased - Cholesterol high | CTCAE V5, Toxicity grade programming, CHOL , Cholesterol increased, Cholesterol high |
Lab: Laboratory data concepts | TASKS_Lab_L222 | Derivation of CTCAE V5 Grades - CREAT - Creatinine increased | CTCAE V5, Toxicity grade programming, CREAT , Creatinine increased |
Lab: Laboratory data concepts | TASKS_Lab_L223 | Derivation of CTCAE V5 Grades - FIBRINO - Fibrinogen decreased | CTCAE V5, Toxicity grade programming, FIBRINO , Fibrinogen decreased |
Lab: Laboratory data concepts | TASKS_Lab_L224 | Derivation of CTCAE V5 Grades - GGT - Gamma-GlutamylTransferase - GGT increased | CTCAE V5, Toxicity grade programming, GGT , Gamma-GlutamylTransferase , GGT increased |
Lab: Laboratory data concepts | TASKS_Lab_L225 | Derivation of CTCAE V5 Grades - LYM - Lymphocyte count decreased | CTCAE V5, Toxicity grade programming, LYM , Lymphocyte count decreased |
Lab: Laboratory data concepts | TASKS_Lab_L226 | Derivation of CTCAE V5 Grades - LYM - Lymphocyte count increased | CTCAE V5, Toxicity grade programming, LYM , Lymphocyte count increased |
Lab: Laboratory data concepts | TASKS_Lab_L227 | Derivation of CTCAE V5 Grades - NEUT - Neutrophil count decreased | CTCAE V5, Toxicity grade programming, NEUT , Neutrophil count decreased |
Lab: Laboratory data concepts | TASKS_Lab_L228 | Derivation of CTCAE V5 Grades - PLAT - Platelet count decreased | CTCAE V5, Toxicity grade programming, PLAT , Platelet count decreased |
Lab: Laboratory data concepts | TASKS_Lab_L229 | Derivation of CTCAE V5 Grades - WBC - White blood cell decreased | CTCAE V5, Toxicity grade programming, WBC , White blood cell decreased |
Lab: Laboratory data concepts | TASKS_Lab_L230 | Derivation of CTCAE V5 Grades - WBC - White blood cell increased - Leukocytosis | CTCAE V5, Toxicity grade programming, WBC , White blood cell increased , Leukocytosis |
Oncology: SDTM and ADaM related programming tasks | TASKS_ONCO_L330 | ADaM - Analysis Flag for Last Evaluable Visit | Oncology, Oncology clinical trials,Last Evaluable Assessment |
Oncology: SDTM and ADaM related programming tasks | TASKS_ONCO_L331 | ADaM - Analysis Flag for First Response | Oncology, Oncology clinical trials,Last Evaluable Assessment |
Oncology: SDTM and ADaM related programming tasks | TASKS_ONCO_L332 | ADaM - Analysis Flag for First Progressive Disease | Oncology, Oncology clinical trials,Last Evaluable Assessment |
Oncology: SDTM and ADaM related programming tasks | TASKS_ONCO_L333 | ADaM - Analysis Flag for Progressive Disease - handling skipped assessments | Oncology, Oncology clinical trials,First progression without skipped assessments |
Oncology: SDTM and ADaM related programming tasks | TASKS_ONCO_L431 | ADaM - BOCR parameter derivation - Best Overall Confirmed Response | BOCR, Best overall confirmed response |
SDTM General Concepts | TASKS_SDTMGEN_L050 | Conversion of raw date values to ISO8601 format | SDTM, ISO8601 date, dates conversion |
SDTM General Concepts | TASKS_SDTMGEN_L070a | SDTM DM dataset RFPENDTC programming - manual approach | SDTM, DM, RFPENDTC |
SDTM General Concepts | TASKS_SDTMGEN_L070a1 | SDTM DM dataset RFPENDTC programming - dynamic approach | Latest date from all raw date variables |
SDTM General Concepts | TASKS_SDTMGEN_L071 | SDTM DM dataset - create planned arm variables | SDTM, DM, Demographics, ARMCD, ARM, Planned arm, description of planned arm |
SDTM General Concepts | TASKS_SDTMGEN_L072 | SDTM DM dataset - create actual arm variables | SDTM, DM, ACTARMCD, ACTARM, Actual arm |
SDTM General Concepts | TASKS_SDTMGEN_L073 | SDTM DM dataset - RFXSTDTC and RFXENDTC | SDTM, DM, RFXSTDTC, RFXENDTC |
SDTM General Concepts | TASKS_SDTMGEN_L074 | SDTM DM dataset - RFICDTC, RFSTDTC and RFENDTC | SDTM, DM, RFICDTC, RFSTDTC, RFENDTC |
SDTM General Concepts | TASKS_SDTMGEN_L075 | SDTM DM dataset - DTHFL and DTHDTC | DTHDTC, DTHFL |
SDTM General Concepts | TASKS_SDTMGEN_L101 | Study Day Derivation in SDTM datasets - using SDTM VS as an example | SDTM, General Programming Concepts, Study day, VS, VSDY |
SDTM General Concepts | TASKS_SDTMGEN_L108 | Creating tests as rows from variables - wide to long transformation | |
SDTM General Concepts | TASKS_SDTMGEN_L109 | Remap unscheduled visits using SV dataset | Visit remapping, unscheduled visits |
SDTM General Concepts | TASKS_SDTMGEN_L110 | Creation of EPOCH variable based on date | |
SDTM General Concepts | TASKS_SDTMGEN_L110a | Creation of EPOCH variable based on date - with partial dates | EPOCH |
SDTM General Concepts | TASKS_SDTMGEN_L111 | Creation of supplementary domain | SUPP |
SDTM General Concepts | TASKS_SDTMGEN_L112 | Create sequence variable | retain, sequence creation |
SDTM General Concepts | TASKS_SDTMGEN_L150 | Convert results in original units to standard units | SDTM, Original results, Standard results |
SDTM General Concepts | TASKS_SDTMGEN_L160 | Creating split variables without word break - Comments - COVAL1, COVAL2 etc | Split, Arrays |
SDTM General Concepts | TASKS_SDTMGEN_L201 | Merge supplementary dataset to parent domain | Merge |
SDTM General Concepts | TASKS_SDTMGEN_L221 | Create xpt file | proc copy, xpt |
Figures: Generic | TFL_FGN_LBAR101 | Bar Chart of Seroconversion | Clinical SAS Graphs, Bar chart |
Figures: Generic | TFL_FGN_LBOXPLOT101 | Box plot of change from baseline values of Hemoglobin over time | Boxplot |
Figures: Generic | TFL_FGN_LSCATTER101 | Scatter Plot of baseline vs postbaseline maximum hemoglobin values | Clinical SAS Graphs, Scatter plot using proc template |
Figures: Time to Event | TFL_FTTE_L101 | Cumulative Incidence Plot | TTE, Time to event, Censor, Events, Lifetest, Cumulative incidence, proc template |
Figures: Time to Event | TFL_FTTE_L101a | Cumulative Incidence Plot | TTE, Time to event, Censor, Events, Lifetest, Cumulative incidence, proc template |
Figures: Time to Event | TFL_FTTE_L101b | Cumulative Incidence Plot | TTE, Time to event, Censor, Events, Lifetest, Cumulative incidence, proc template, axistable |
Listings: Adverse Events | TFL_LAE_L101 | Adverse Events | Adverse Events, SOC PT indentation using \pnhang\par\li200, {\line} for new line, split character, asis=on, protectspecialchars=off |
Listings: Demographics | TFL_LDM_L101 | Demographic Characteristics | Demographic characteristics, baseline height, baseline weight |
Listings: Disposition | TFL_LDS_L101 | Screen Failures | Screen Failures |
Listings: Disposition | TFL_LDS_L102 | Inclusion/Exclusion From Analysis Sets | Analysis Set Inclusion/Exclusion |
Listings: Disposition | TFL_LDS_L103 | Treatment Discontinuation | Treatment Discontinuation |
Listings: Disposition | TFL_LDS_L104 | Dates of First and Last Evaluations | First Evaluation - RFICDT, Last Evaluation - RFPENDT |
Listings: Protocol Deviations | TFL_LDV_L103 | Protocol Deviations | Protocol deviations, deviation code, deviation subcode |
Listings: ECG | TFL_LEG_L101 | ECG Results | ECG Results |
Listings: Medical History | TFL_LMH_L101 | Medical History | Medical History |
ODS RTF: Report formatting | TFL_ODSRTF_L211 | Add indentation for preferred terms in AE by SOC and PT table using RTF tag | li220,^w |
ODS RTF: Report formatting | TFL_ODSRTF_L212 | Present SOC values in bold font in an AE SOC and PT table using RTF tag | li220,^w |
ODS RTF: Report formatting | TFL_ODSRTF_L213 | Present specific values in red font in an AE SOC and PT table using RTF tag | li220,^w |
ODS RTF: Report formatting | TFL_ODSRTF_L214 | Spanning header - underline under certain treatment column groups | li220,^w |
ODS RTF: Report formatting | TFL_ODSRTF_L215 | Adding a superscript and a subscript to the data values using rtf tag | li220,^w |
ODS RTF: Report formatting | TFL_ODSRTF_L221 | Present a set of columns on one page and second of columns on a second page - basic example | |
ODS RTF: Report formatting | TFL_ODSRTF_L301 | Missing option on proc report statement - variables defined as 'order' variables | |
ODS RTF: Report formatting | TFL_ODSRTF_L401 | Pagination : demog table like layout which contain multiple sections | |
Table programming - General Concepts | TFL_TABGEN_L201 | Descriptive statistics for a single numeric variable | proc summary, completetypes, preloadfmt, proc format, descriptive statistics |
Table programming - General Concepts | TFL_TABGEN_L202 | Descriptive statistics for two numeric variables | proc summary, completetypes, preloadfmt, proc format, descriptive statistics |
Table programming - General Concepts | TFL_TABGEN_L301 | Summary for categorical variables - one variable - Sex | proc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx |
Table programming - General Concepts | TFL_TABGEN_L302 | Summary for categorical variables - two variables - Sex and race | proc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx |
Table programming - General Concepts | TFL_TABGEN_L401 | Demographic characteristics - 2 numeric, 2 categorical variables | proc summary, categorical variables, numeric variables, proc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx |
Tables: Adverse Events | TFL_TAE_L100 | Overview of Treatment-Emergent Adverse Events - Subject count and Event count | TFL, TAE, Adverse Events, Overview, DUMMY_SHELL_CREATION, DUMMY_TREATMENT_TOTALS, Subject counts, Event counts |
Tables: Adverse Events | TFL_TAE_L101 | Treatment emergent adverse events, by primary system organ class and preferred term | AE,TEAE,SOC,PT,BY SOC and PT,Adverse Events |
Tables: Adverse Events | TFL_TAE_L102 | Treatment-Emergent Adverse Events by Maximum Severity | AE,TEAE,SOC,PT,BY SOC and PT,Adverse Events,By Maximum severity |
Tables: Adverse Events | TFL_TAE_L103 | Treatment-Emergent Adverse Events by SOC and PT sorted by descending frequency | AE,TEAE,SOC,PT,BY SOC and PT,Adverse Events, By Descending Frequency |
Tables: Adverse Events | TFL_TAE_L103a | Treatment-Emergent Adverse Events by SOC and PT sorted by descending frequency - SOC repeated on page | AE,TEAE,SOC,PT,BY SOC and PT,Adverse Events, By Descending Frequency |
Tables: Adverse Events | TFL_TAE_L103b | Treatment-Emergent Adverse Events by SOC and PT sorted by descending frequency - SOC repeated on page | AE,TEAE,SOC,PT,BY SOC and PT,Adverse Events, By Descending Frequency,SOC Continued |
Tables: Adverse Events | TFL_TAE_L104 | Treatment-Emergent Adverse Events by Relationship to Study Drug | AE,TEAE,SOC,PT,BY SOC and PT,Adverse Events,By Maximum Relationship to study drug |
Tables: Adverse Events | TFL_TAE_L105 | Treatment-Emergent Adverse Events by Preferred Term - Descending frequency | AE,TEAE,PT,BY Preferred term,Adverse Events,descending frequency |
Tables: Adverse Events | TFL_TAE_L105a | Treatment-Emergent Adverse Events by Preferred Term | AE,TEAE,PT,BY Preferred term,Adverse Events |
Tables: Adverse Events | TFL_TAE_L105a1 | Treatment-Emergent Adverse Events by Preferred Term (descending frequency) | AE,TEAE,PT,BY Preferred term,Adverse Events |
Tables: Adverse Events | TFL_TAE_L106 | TEAE That Equal to or Exceed a Threshold of 5% in Any Treatment Group | AE,TEAE,SOC,PT,BY SOC and PT,Threshold,percent cutoff,5% |
Tables: Adverse Events | TFL_TAE_L107 | Treatment-Emergent Adverse Events by Preferred Term - with fisher exact test p-value | AE,TEAE,PT,BY Preferred term,Adverse Events, p-value(only for low dose vs placebo) |
Tables: Adverse Events | TFL_TAE_L107a | TEAE by PT - with chisq/fisher exact test p-value | AE,TEAE,PT,BY Preferred term,Adverse Events, p-value,chisq,fisher,expected count |
Tables: Adverse Events | TFL_TAE_L108 | TEAE by PT - Odds Ratio | AE,TEAE,PT,BY Preferred term,Adverse Events, odds ratio, 95% confidence intervals, relrisk option in proc freq tables statement |
Tables: Adverse Events | TFL_TAE_L108a | TEAE by PT - Odds Ratio with p-value | AE,TEAE,PT,BY Preferred term,Adverse Events, odds ratio, 95% confidence intervals, p-value, proc logistic, lsmeans, diff |
Tables: Adverse Events | TFL_TAE_L109 | TEAE by PT - Risk Ratio | AE,TEAE,PT,BY Preferred term,Adverse Events, risk ratio, 95% confidence intervals, relrisk option in proc freq tables statement |
Tables: Adverse Events | TFL_TAE_L110 | TEAE by PT - Risk Difference | AE,TEAE,PT,BY Preferred term,Adverse Events, risk difference, 95% confidence intervals, riskdiff option in proc freq tables statement |
Tables: Adverse Events | TFL_TAE_L111 | Exposure Adjusted Treatment-Emergent Adverse Event Rate by SOC and PT sorted by descending rate | TEAE,Exposure Adjusted Event Rate, Subject-years, Event counts, |
Tables: Adverse Events | TFL_TAE_L112 | Exposure Adjusted Treatment-Emergent Adverse Subject Incidence Rate by SOC and PT sorted by descending rate | TEAE;Exposure Adjusted Event Rate; Subject-years; Event counts; |
Tables: Adverse Events | TFL_TAE_L113 | TEAE by SOC, PT and Grade | AETOXGR, Toxicity Grade, CTCAE |
Tables: Concomitant Medications | TFL_TCM_L101 | Concomitant Medications | CM,ATC classification,ATC2,ATC4,CMDECOD,Concomitant Medication, 3 Levels, Subject counts |
Tables: Concomitant Medications | TFL_TCM_L102 | Concomitant Medications by preferred term | CM,CMDECOD,Concomitant Medication, Subject counts, Descending frequency |
Tables: Demographics and Baseline Characteristics | TFL_TDM_L100 | Demographic Characteristics - without using macros | proc 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_L101 | Demographic Characteristics | DM, Demographics, Baseline Characteristics, Counts macro, Descriptive macro, Sex, Age, Race, Height, Weight, BMi |
Tables: Disposition | TFL_TDS_L101 | Summary of Analysis Sets | |
Tables: Disposition | TFL_TDS_L102 | Treatment Disposition | Treatment disposition, nway, completetypes, preloadfmt |
Tables: Disposition | TFL_TDS_L102a | Treatment Disposition - coding approach 2 | Treatment disposition, dummy shell creation |
Tables: ECG | TFL_TEG_L101 | Interpretation of ECG Results | EG,ECG,Abnormality, Interpretation,Modified Denom,Dummy creation,Subject counts |
Tables: ECG | TFL_TEG_L102 | ECG Results: Result and Change From Baseline | EG, ECG, Result and Change from baseline, By visit, Param as page header, stats as columns, Complex Report logic |
Tables: ECG | TFL_TEG_L103 | Categorized Absolute Value in QTcB - Non-exclusive categories - Multiple CRIT variables | EG,ECG,QTC Abnormality, Modified Denom,Dummy creation,Subject counts |
Tables: ECG | TFL_TEG_L104 | Categorized Absolute Value in QTcB - Exclusive categories - AVALCAT1 | EG,ECG,QTC Result Categorization, Modified Denom,Dummy creation,Subject counts |
Tables: ECG | TFL_TEG_L105 | Categorized Change from Baseline in QTcB ? Non-exclusive categories - Multiple CRIT | EG,ECG,QTC Abnormality, Modified Denom,Dummy creation,Subject counts |
Tables: ECG | TFL_TEG_L106 | Shift Table for ECG Interpretation | EG,ECG,Abnormality, Interpretation,Shift Table |
Tables: ECG | TFL_TEG_L106a | Shift Table for ECG Interpretation - Including Missing Row | EG,ECG,Abnormality, Interpretation,Shift Table |
Tables: ECG | TFL_TEG_L106b | Shift Table for ECG Interpretation - with treatment and postbaseline results as rows | EG,ECG,Abnormality, Interpretation,Shift Table |
Tables: Exposure | TFL_TEX_L101 | Study Drug Exposure | proc summary, categorical variables, numeric variables, proc freq, dummy creation, all levels, missing row, percentage calculation, macro variables, call sumputx |
Tables: Inferential Statistics | TFL_TIS_L101 | Fisher's exact : Comparison of proportions - Adverse Events | Comparsion of proportions, Fisher's exact, p-value |
Tables: Inferential Statistics | TFL_TIS_L111 | Chi-Square: Comparison of proportions - Demographics | Comparsion of proportions, Chi-square, Demographics |
Tables: Inferential Statistics | TFL_TIS_L121 | ANOVA: Comparison of means - Demographics | Comparsion of means, ANOVA, Demographics |
Tables: Inferential Statistics | TFL_TIS_L131 | Binomial Test: Inference about a proportion - Responder analysis | Exact Binomial, Confidence intervals, 95% CI |
Tables: Inferential Statistics | TFL_TIS_L141 | Odds Ratio: Simple Logistic Regression - Responder Analysis | Odds ratio, wald, logistic regression, responder analysis, 95% confidence interval |
Tables: Inferential Statistics | TFL_TIS_L151 | ANCOVA: Change from baseline analysis | ANCOVA, Change from baseline, HBA1C, COVARIATE |
Tables: Inferential Statistics | TFL_TIS_LTTEST101 | One-Sample t-Test - analysis of BMI | Inferential statistics, one sample t-test in sas |
Tables: Laboratory Results Analsysis | TFL_TLB_L101 | Actual Value and Change from Baseline for Laboratory Tests by Visit | TFL,LB,Descriptive stats,Auto-decimal,Auto-rounding, By visit, RTF underline, RTF dummy column, RTF indentation |
Tables: Laboratory Results Analsysis | TFL_TLB_L102 | Descriptive statistics Actual Value and Change from Day 1 during each cycle | TFL,LB,Descriptive stats,Change from Day 1,Auto-decimal,Auto-rounding, By visit, RTF underline, RTF dummy column, RTF indentation |
Tables: Laboratory | TFL_TLB_L103 | Shift Table for Laboratory Test Results | LB, Laboratory analysis, shift table, low, normal, high, missing, no data, Modified denoms, Dummy creation |
Tables: Laboratory | TFL_TLB_L104 | Summary Shifts in Laboratory Test Results | LB, Laboratory analysis, Sumary shifts table, low, normal, high, missing, no data, Modified denoms,at-risk denoms,'at risk', Dummy creation |
Tables: Laboratory | TFL_TLB_L105 | Shift from Baseline to Worst Value Post-Baseline in Terms of CTCAE Grades | Laboratory, shift, CTCAE |
Tables: Laboratory | TFL_TLB_L106 | Shifts in Laboratory Test Results in terms of CTCAE Grades | Laboratory,shift,CTCAE,ATOXGR,BTOXGR |
Tables: Medical History | TFL_TMH_L101 | Medical History by SOC and PT | MH,SOC,PT,BY SOC and PT,Medical History,Subject counts |
Tables: Response Analysis | TFL_TRS_L103 | Response Analysis: Concordance between IRC and Investigator Best Response Analysis | ADRS, Tumor Response Evaluation, Concordance |
Tables: Time to Event | TFL_TTTE_L101 | Overall Survival by Treatment Group | TTE, Time to event, Censor, Events, Lifetest, Quartiles, 95 % Ci |
Tables: Time to Event | TFL_TTTE_L101a | Overall Survival by Treatment Group | TTE, Time to event, Censor, Events, Lifetest, Quartiles, 95 % Ci |
Tables: Time to Event | TFL_TTTE_L101b | Overall Survival by Treatment Group | TTE, Time to event, Censor, Events, Lifetest, Quartiles, 95 % Ci, PHREG, Hazard ratio |
Tables: Vital Signs | TFL_TVS_L101 | Vital Signs: Result and Change From Baseline | VS, 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_L101a | Vital Signs: Result and Change From Baseline | Vital signs, Result and Change from Baseline |
Tables: Vital Signs | TFL_TVS_L102 | Potentially Clinically Significant Vital Signs | VS, Vital Signs, Potentially Clinically Significant Vital Signs, n/m,ncount,mcount, Modified denom |