| Question | Response |
|---|---|
| Were any medical conditions or events reported? [MHYN] |
Yes No |
| Question | Response |
|---|---|
| Medical History Category (Defaulted, Hidden) [MHCAT] |
General Medical History |
| Collection Date [MHDAT_RAW] |
|
| Line Number (Derived, Hidden) [MHSPID] |
|
| Medical History Term [MHTERM] |
|
| Start Date [MHSTDAT_RAW] |
|
| Is the medical condition or event ongoing? [MHONGO] |
Yes No |
| End Date [MHENDAT_RAW] |
|
| Question | Response |
|---|---|
| Primary Tumor Type [CXTUMTYP] |
|
| Primary Tumor Type [CXTUMTYP] |
|
| Primary Tumor Type [CXTUMTYP] |
|
| Primary Tumor Type [CXTUMTYP] |
|
| Primary Tumor Type [CXTUMTYP] |
|
| Primary Tumor Type [CXTUMTYP] |
|
| Primary Tumor Type [CXTUMTYP] |
|
| Primary Tumor Type [CXTUMTYP] |
|
| Other, specify [CXTUMOS] |
|
| Date of Initial Diagnosis (DD MON YYYY) [DXDTC] |
|
| Initial Staging [CXINSTAG] |
|
| Initial Staging [CXINSTAG] |
|
| Initial Staging [CXINSTAG] |
|
| Initial Staging [CXINSTAG] |
|
| Initial Staging [CXINSTAG] |
|
| Initial Staging [CXINSTAG] |
|
| Initial Staging [CXINSTAG] |
|
| Initial Staging [CXINSTAG] |
|
| Other, specify [CXSPEC] |
|
| Date of most recent occurrence (DD MON YYYY) [CXRECDAT_RAW] |
|
| Stage at most recent occurrence [CXRCSTAG] |
|
| Stage at most recent occurrence [CXRCSTAG] |
|
| Stage at most recent occurrence [CXRCSTAG] |
|
| Stage at most recent occurrence [CXRCSTAG] |
|
| Stage at most recent occurrence [CXRCSTAG] |
|
| Stage at most recent occurrence [CXRCSTAG] |
|
| Stage at most recent occurrence [CXRCSTAG] |
|
| Stage at most recent occurrence [CXRCSTAG] |
|
| Other, specify [CXSTAGO] |
|
| Metastatic sites (choose all that apply): [LABEL] |
|
| Adrenals [CXMET1] |
|
| Brain [CXMET2] |
|
| Bone [CXMET3] |
|
| Lung [CXMET4] |
|
| Liver [CXMET5] |
|
| Lymph nodes [CXMET6] |
|
| Other Metastatic site [CXMETO] |
|
| Other, specify [CXMETOS] |
| SUPP | VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT | FORM_RMH | FORM_RCXHIST_INDIAG | FORM_RCXHIST_RECDIAG |
|---|---|---|---|---|---|---|---|
| _ | General | _isb | Create a record only if rcxhist.CXRECDAT_RAW is not null. | ||||
| _ | STUDYID | Study Identifier | Char | Populate as 'statschoice' | |||
| _ | DOMAIN | Domain Abbreviation | Char | Populate as 'MH' | |||
| _ | USUBJID | Unique Subject Identifier | Char | Concatenate sdtm.mh.STUDYID to rmh.SUBJECT with a hyphen in between. | Concatenate sdtm.mh.STUDYID to rcxhist.SUBJECT with a hyphen in between. | Concatenate sdtm.mh.STUDYID to rcxhist.SUBJECT with a hyphen in between. | |
| _ | MHSEQ | Sequence Number | Num | Sort the records based on STUDYID, USUBJID, MHTERM, MHSTDTC. Set to 1 on the first record of the subject and increment by 1 on subsequent records. | |||
| _ | MHSPID | Sponsor-Defined Identifier | Char | Convert rmh.MHSPID to a 3 character wide string by adding leading zeros where applicable and concatenate "RMH-" as a prefix to it. | Convert rcxhist.RECORDPOSITION to a 3 character wide string by adding leading zeros where applicable and concatenate "RCXHIST-" as a prefix to it. | Convert rcxhist.RECORDPOSITION to a 3 character wide string by adding leading zeros where applicable and concatenate "RCXHIST-" as a prefix to it. | |
| _ | MHTERM | Reported Term for the Medical History | Char | Populate using rmh.MHTERM | Populate using rcxhist.CXTUMTYP | Populate using rcxhist.CXTUMTYP | |
| _ | MHCAT | Category for Medical History | Char | Populate using rmh.MHCAT | Populate as 'CANCER HISTORY' | Populate as 'CANCER HISTORY' | |
| _ | MHDTC | Date/Time of History Collection | Char | Populate using rmh.MHDAT_RAW, after converting it to ISO 8601 format. | |||
| _ | MHSTDTC | Start Date/Time of Medical History Event | Char | Populate using rmh.MHSTDAT_RAW, after converting it to ISO 8601 format. | Populate using rcxhist.DXDTC, after converting it to ISO 8601 format. | Populate using rcxhist.CXRECDAT_RAW, after converting it to ISO 8601 format. | |
| _ | MHENDTC | End Date/Time of Medical History Event | Char | Populate using rmh.MHENDAT_RAW, after converting it to ISO 8601 format. | |||
| _ | MHDY | Study Day of History Collection | Num | Populate it using sdtm.mh.MHDTC and sdtm.dm.RFSTDTC. Set to the difference of MHDTC and RFSTDTC when MHDTC is before RFSTDTC. Set to the difference between MHDTC and RFSTDTC +1 when MHDTC is on or after RFSTDTC. | |||
| _ | MHSTDY | Study Day of Start of Med.History Event | Num | Populate it using sdtm.mh.MHSTDTC and sdtm.dm.RFSTDTC. Set to the difference of MHSTDTC and RFSTDTC when MHSTDTC is before RFSTDTC. Set to the difference between MHSTDTC and RFSTDTC +1 when MHSTDTC is on or after RFSTDTC. | |||
| _ | MHENDY | Study Day of End of Med. History Event | Num | Populate it using sdtm.mh.MHENDTC and sdtm.dm.RFSTDTC. Set to the difference of MHENDTC and RFSTDTC when MHENDTC is before RFSTDTC. Set to the difference between MHENDTC and RFSTDTC +1 when MHENDTC is on or after RFSTDTC. | |||
| _ | MHENRTPT | End Relative to Reference Time Point | Char | Populate using rmh.MHONGO. When MHONGO=Yes, then set to ONGOING. | |||
| _ | MHENTPT | End Reference Time Point | Char | Populate it with rmh.MHDTC when sdtm.mh.MHENRTPT=ONGOING. |