myCSG © |Area: SDTM| Concept: RS : Disease Response and Clin Classification | Lesson: LCHPU : SDTM RS dataset - Child-Pugh Classification |
Complete key programming for SDTM RS domain
This lesson covert the clinical classification named Child-Pugh Classification
Child-Pugh Classification is used in hepatic impairment assessment
Programming aspects include:
Creation of rows for testcds from variables using arrays
Derivation of --LOBXFL
Creation of study day and other SDTM general variables
Lesson description will be added soon
This lesson covert the clinical classification named Child-Pugh Classification
Child-Pugh Classification is used in hepatic impairment assessment
Programming aspects include:
Creation of rows for testcds from variables using arrays
Derivation of --LOBXFL
Creation of study day and other SDTM general variables
Lesson description will be added soon
CHPU : Child-Pugh Classification
| Question | Response |
|---|---|
| Date Collected [RSDAT_RAW] |
|
| Encephalopathy grade [CHPU_1] |
1:None 2:1 or 2 3:3 or 4 |
| Ascites [CHPU_2] |
1:Absent 2:Slight 3:Moderate |
| Serum bilirubin, mg/dL [CHPU_3] |
1:<2 2:2 to 3 3:>3 |
| Serum albumin, g/dL [CHPU_4] |
1:>3.5 2:2.8 to 3.5 3:<2.8 |
| Prothrombin time, sec prolonged [CHPU_5] |
1:<4 2:4 to 6 3:>6 |
| SUPP | VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT | FORM_CHPU |
|---|---|---|---|---|---|
| _ | STUDYID | Study Identifier | Char | Populate as 'statschoice' | |
| _ | DOMAIN | Domain Abbreviation | Char | Populate as 'RS' | |
| _ | USUBJID | Unique Subject Identifier | Char | Concatenate the value of STUDYID variable to SUBJECT variable with a hyphen in between. | |
| _ | RSSEQ | Sequence Number | Num | Sort the records by USUBJID, RSCAT, RSTESTCD, RSDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject | |
| _ | RSTESTCD | Assessment Short Name | Char | Create a record with RSTESTCD=CPS0101 to store the result from CHPU_1. Create a record with RSTESTCD=CPS0102 to store the result from CHPU_2. Create a record with RSTESTCD=CPS0103 to store the result from CHPU_3. Create a record with RSTESTCD=CPS0104 to store the result from CHPU_4. Create a record with RSTESTCD=CPS0105A to store the result from CHPU_5. |
|
| _ | RSTEST | Assessment Name | Char | Populate as 'CPS01-Encephalopathy Grade' when RSTESTCD=CPS0101. Populate as 'CPS01-Ascites' when RSTESTCD=CPS0102. Populate as 'CPS01-Serum Bilirubin' when RSTESTCD=CPS0103. Populate as 'CPS01-Serum Albumin' when RSTESTCD=CPS0104. Populate as 'CPS01-PT, Sec Prolonged' when RSTESTCD=CPS0105A. |
|
| _ | RSCAT | Category for Assessment | Char | Populate as "CHILD-PUGH CLASSIFICATION" | |
| _ | RSORRESU | Original Units | Char | Populate with the values from RS.RSORRES | Populate using CHPU_1 when creating row for RSTESTCD=CPS0101. Populate using CHPU_2 when creating row for RSTESTCD=CPS0102. Populate using CHPU_3 when creating row for RSTESTCD=CPS0103. Populate using CHPU_4 when creating row for RSTESTCD=CPS0104. Populate using CHPU_5 when creating row for RSTESTCD=CPS0105A. Populate using the second component from the individual variables when ":" is the separator of components. |
| _ | RSSTRESC | Character Result/Finding in Std Format | Char | Populate using CHPU_1 when creating row for RSTESTCD=CPS0101. Populate using CHPU_2 when creating row for RSTESTCD=CPS0102. Populate using CHPU_3 when creating row for RSTESTCD=CPS0103. Populate using CHPU_4 when creating row for RSTESTCD=CPS0104. Populate using CHPU_5 when creating row for RSTESTCD=CPS0105A. Populate using the first component from the individual variables when ":" is the separator of components. |
|
| _ | RSSTRESN | Numeric Result/Finding in Standard Units | Num | Popuate with the values from RS.RSSTRESC after converting to numeric format where applicable. | |
| _ | RSSTRESU | Standard Units | Char | Populate as null. | |
| _ | RSLOBXFL | Last Observation Before Exposure Flag | Char | Populate as "Y" on the latest record with non-missing result on or prior to DM.RFXSTDTC for each subject and test. | |
| _ | VISITNUM | Visit Number | Num | Populate with the value from FOLDERSEQ | |
| _ | VISIT | Visit Name | Char | Populate with the value from FOLDERNAME | |
| _ | RSDTC | Date/Time of Assessment | Char | Populate using RSDAT_RAW after converting to ISO8601 format. | |
| _ | RSDY | Study Day of Assessment | Num | Populate using RS.RSDTC and DM.RFSTDTC. If RSDTC is on or after RFSTDTC then populate with the resulting value of RSDTC-RFSTDTC+1. Else if RSDTC is before RFSTDTC then populate with the resulting value of RSDTC-RFSTDTC. |
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