| Question | Response |
|---|---|
| Was kidney morphology assessed? [MOYN] |
Yes No |
| If not done, reason examination not done [REASND] |
|
| Date of assessment [MODAT] |
|
| Laterality [LATERALITY] |
Left Right |
| Observed width (mm) [MOWIDTH] |
|
| Observed length (mm) [MOLENGTH] |
|
| Observed depth (mm) [MODEPTH] |
|
| SUPP | VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT | FORM_MORPHO |
|---|---|---|---|---|---|
| _ | STUDYID | Study Identifier | Char | Set to 'statschoice' | |
| _ | DOMAIN | Domain Abbreviation | Char | Set to 'MO' | |
| _ | USUBJID | Unique Subject Identifier | Char | Concatenate morpho.PROJECT and morpho.SUBJECT with a hyphen in between. | |
| _ | MOSEQ | Sequence Number | Num | Sort the records by USUBJID, MOTESTCD, MODTC, MOLAT, MOSPID and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject. | |
| _ | MOTESTCD | Test or Examination Short Name | Char | Create a record with 'MOALL' when MOYN=No. When MOYN=Yes create separate records for each measurement. Populate as 'LENGTH' when creating a record using morpho.MOLENGTH. Populate as 'WIDTH' when creating a record using morpho.MOWIDTH. Populate as 'DEPTH' when creating a record using morpho.MODEPTH. |
|
| _ | MOTEST | Test or Examination Name | Char | Populate as 'Length' when SDTM.MO.MOTESTCD=LENGTH. Populate as 'Width' when SDTM.MO.MOTESTCD=WIDTH. Populate as 'Depth' when SDTM.MO.MOTESTCD=DEPTH Populate as 'Morphology Findings' when SDTM.MO.MOTESTCD=MOALL. |
|
| _ | MOORRES | Result or Finding in Original Units | Char | Populate using morpho.MOLENGTH when creating the record for SDTM.MO.MOTESTCD=LENGTH. Populate using morpho.MOWIDTH when creating the record for SDTM.MO.MOTESTCD=WIDTH. Populate using morpho.MODEPTH when creating the record for SDTM.MO.MOTESTCD=DEPTH. Leave null when creating the record for SDTM.MO.MOTESTCD=MOALL. |
|
| _ | MOORRESU | Original Units | Char | Populate as 'mm' when SDTM.MO.MOTESTCD is LENGTH, WIDTH, DEPTH | |
| _ | MOSTRESC | Character Result/Finding in Std Format | Char | Populate using SDTM.MO.MOORRES | |
| _ | MOSTRESN | Numeric Result/Finding in Standard Units | Num | Populate using the SDTM.MO.MOSTRESC after converting to numeric value | |
| _ | MOSTRESU | Standard Units | Char | Populate using SDTM.MO.MOORRESU | |
| _ | MOSTAT | Completion Status | Char | Populate as 'NOT DONE' when SDTM.MO.MOTESTCD=MOALL Populate as 'NOT DONE' when is SDTM.MO.MOLENGTH is null when SDTM.MO.MOTESTCD=LENGTH. Populate as 'NOT DONE' when is SDTM.MO.MOWIDTH is null when SDTM.MO.MOTESTCD=WIDTH. Populate as 'NOT DONE' when is SDTM.MO.MODEPTH is null when SDTM.MO.MOTESTCD=DEPTH. |
|
| _ | MOREASND | Reason Test Not Performed | Char | Populate using morpho.REASND when SDTM.MO.MOTESTCD=MOALL. Populate as 'Not collected' when SDTM.MO.MORRES is null when SDTM.MO.MOTESTCD is not MOALL. |
|
| _ | MOLOC | Location Used for Measurement | Char | Populate as 'KIDNEY' | |
| _ | MOLAT | Specimen Laterality within Subject | Char | Populate using morpho.LATERALITY after converting to upper case | |
| _ | MOMETHOD | Method of Procedure Test | Char | Populate as 'CT SCAN' | |
| _ | MOBLFL | Baseline Flag | Char | Set to "Y" on the latest record with non-missing result on or prior to SDTM.DM.RFSTDTC per each test. | |
| _ | VISITNUM | Visit Number | Num | Populate using FOLDERSEQ for scheduled visits. For unscheduled visits, add.01 to the previous scheduled or unscheduled visit number and assign the value assign the value as 'x.xx' (for programming purposes, use SDTM.SV dataset to get the VISITNUM associated with the unscheduled visit date). | |
| _ | VISIT | Visit Name | Char | Populate using FOLDERNAME after converting to upper case for scheduled visits. For unscheduled visits, add 1 to the previous scheduled or unscheduled visit number and assign the value as the prior scheduled visit name with ' - Unscheduled x' added where x reflects the unscheduled visit number (for programming purposes, use SDTM.SV dataset to get the VISIT associated with the unscheduled visit date). | |
| _ | EPOCH | Epoch | Char | Populate using SDTM.SE.EPOCH by comparing SDTM.MO.MODTC with SESTDTC and SEENDTC of each element of the subject. Populate as 'TREATMENT' when the record falls on the boundary of SCREENING and TREATMENT elements. Populate as 'TREATMENT' when the record falls on the boundary of TREATMENT and FOLLOW-UP. | |
| _ | MODTC | Date/Time of Test | Char | Populate using morpho.MODAT in ISO 8601 format. | |
| _ | MODY | Study Day of Test | Num | If the SDTM.MO.MODTC is on or after reference start date then SDTM.MO.MODTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.MO.MODTC-SDTM.DM.RFSTDTC. |