myCSG © |Area: ADaM| Concept: ADIS : Full ADIS - Immunogenicity Analysis Dataset | Lesson: LVAC01 : ADIS - Immune response in a vaccine study - 001 |
- Complete programming of Immunogenicity analysis dataset (ADIS) for a vaccine study
- Antibody titer is measured pre and post vaccination
- Response is said to be achieved when titer value is greater than or equals to 200
- Programming involves:
- Visit windowing
- Analysis flags
- Baseline, change and ratio to baseline
- Criteria flags
| VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT |
|---|---|---|---|
| STUDYID | Study Identifier | _ | IS.STUDYID |
| USUBJID | Unique Subject Identifier | _ | IS.USUBJID |
| ISSEQ | Sequence Number | _ | IS.ISSEQ |
| ADT | Analysis Date | _ | Populate using IS.ISDTC |
| ADY | Analysis Relative Day | _ | Populate using ADSL.TRTSDT and ADIS.ADT. If ADT is on or after treatment start date then populate as the difference between ADT and TRTSDT and add one to the difference. Else if ADT is before TRTSDT then populate as the difference between ADT and TRTSDT. |
| VISITNUM | Visit Number | _ | IS.VISITNUM |
| VISIT | Visit Name | _ | IS.VISIT |
| AVISIT | Analysis Visit | _ | Part 1: Populate as 'Screening' when ADY <=-1. Populate as 'Visit 1' when 1<= ADY <=1. Populate as 'Visit 2' when 7<= ADY <=9. Populate as 'Visit 3' when 25<= ADY <=33. Populate as 'Visit 4' when 78<= ADY <=92. Populate as 'Visit 5' when 166<= ADY <=194. Populate as 'Visit 6' when 351<= ADY <=379. Part 2: Populate as 'Baseline' on the record where ABLFL is 'Y'. |
| AVISITN | Analysis Visit (N) | _ | Part 1: Populate as -1 when AVISIT='Screening'. Populate as 1 when AVISIT='Visit 1'. Populate as 2 when AVISIT='Visit 2'. Populate as 3 when AVISIT='Visit 3'. Populate as 4 when AVISIT='Visit 4'. Populate as 5 when AVISIT='Visit 5'. Populate as 6 when AVISIT='Visit 6'. Part 2: Populate as 0 on the record where ABLFL is 'Y'. |
| PARAM | Parameter | _ | Populate as 'Titer (GCE/ml)' when PARAMCD='TITER'. |
| PARAMCD | Parameter Code | _ | For the source records: set to ISTESTCD |
| PARAMN | Parameter (N) | _ | Populate as 1 when PARAMCD='TITER'. |
| AVAL | Analysis Value | _ | A. For the source records: Set to ISSTRESN |
| BASE | Baseline Value | _ | Populate using ADIS.AVAL on the record where ADIS.ABLFL="Y" of each parameter and subject on all records that subject and parameter. |
| CHG | Change from Baseline | _ | Populate as the difference between ADIS.AVAL and ADIS.BASE on postbaseline records (ADIS.ANL02FL="Y"). |
| R2BASE | Ratio to Baseline | _ | On postbaseline records (ANL02FL="Y") where PARAMCD="TITER": Populate with the ratio of AVAL to BASE (AVAL/BASE). Round the ratio to two decimal places. |
| CRIT1 | Analysis Criterion 1 | _ | Populate as "Seroresponse - Titer >=200" on records where PARAMCD="TITER". |
| CRIT1FL | Criterion 1 Evaluation Result Flag | _ | On records where PARAMCD="TITER": Populate as "Y" when AVAL>=200. Else if AVAL is not null, then populate as "N". |
| CRIT2 | Analysis Criterion 2 | _ | Populate as "Seroconversion - > 4 fold increase from baseline" on records where PARAMCD="TITER". |
| CRIT2FL | Criterion 2 Evaluation Result Flag | _ | On postbaseline records (ANL02FL="Y") where PARAMCD="TITER": Populate as "Y" when R2BASE > 4. Else if R2BASE is not null then populate as "N". |
| AWTARGET | Analysis Window Target | _ | Populate as null when AVISIT='Screening'. Populate as 1 when AVISIT='Visit 1'. Populate as 8 when AVISIT='Visit 2'. Populate as 29 when AVISIT='Visit 3'. Populate as 85 when AVISIT='Visit 4'. Populate as 180 when AVISIT='Visit 5'. Populate as 365 when AVISIT='Visit 6'. |
| AWTDIFF | Analysis Window Diff from Target | _ | Populate as the absolute difference between AWTARGET and ADY |
| AWLO | Analysis Window Beginning Timepoint | _ | Populate as null when AVISIT='Screening'. Populate as 1 when AVISIT='Visit 1'. Populate as 7 when AVISIT='Visit 2'. Populate as 25 when AVISIT='Visit 3'. Populate as 78 when AVISIT='Visit 4'. Populate as 166 when AVISIT='Visit 5'. Populate as 351 when AVISIT='Visit 6'. |
| AWHI | Analysis Window Ending Timepoint | _ | Populate as -1 when AVISIT='Screening'. Populate as 1 when AVISIT='Visit 1'. Populate as 9 when AVISIT='Visit 2'. Populate as 33 when AVISIT='Visit 3'. Populate as 92 when AVISIT='Visit 4'. Populate as 194 when AVISIT='Visit 5'. Populate as 379 when AVISIT='Visit 6'. |
| AWU | Analysis Window Unit | _ | Populate as "DAYS" when AVISIT is not null. |
| ABLFL | Baseline Record Flag | _ | Populate as "Y" on the latest record with non-missing result on or prior to treatment start date (ADSL.TRTSDT) for each subject and parameter. |
| ANL01FL | Analysis Flag 01 | _ | Populate as "Y" on the records which is closet to the target day within each analysis visit (ADIS.AVISIT) per subject and parameter. If there exists multiple records which are equally close to the target day, choose the latest record. |
| ANL02FL | Analysis Flag 02 | _ | Populate as "Y" on postbaseline records (ADIS.ADT>ADSL.TRTSDT). |
Complete SAS code to generate the output is available for registered users!
Already registered! Login
Not registered, you can signup here! Signup
Dont want to register?
You can directly purchase this lesson (code+input data) here
Already registered! Login
Not registered, you can signup here! Signup
Dont want to register?
You can directly purchase this lesson (code+input data) here
You can purchase this lesson (code+input data) here
If you are looking to purchase subscription for full access to data and programs for all lessons (TASKS+SDTM+ADaM+TFLs), you can send us a message on +91-7330--77--66--49-- on Whatsapp.