Sub-Domain: sites
CRF: scdc
CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (Question Text) | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
C58880 | Aspartate aminotransferase high measurement | ASTHighMeasr | Highest measurement of AST (aspartate aminotransferase). | Highest measurement of AST (aspartate aminotransferase). | Highest AST value | Numeric Values |
Record the highest value during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 10:46:11.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
0 | 9999 | unit per liter | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGAST | |||||||||||||||||||||||||
C58912 | Zenapax therapy chronic GVHD indicate code | ZenapaxThpyChrnGVHDIndCode | Code indicating whether Zenapax (Daclizumab) therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether Zenapax (Daclizumab) therapy was used to treat chronic GVHD (graft-versus-host disease) | Zenapax (Daclizumab) | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHZENA | ||||||||||||||||||||||||||
C58848 | Tacrolimus use GVHD prophylaxis indicate code | TacrUseGVHDProphylaxisIndCode | Code indicating whether Tacrolimus was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether Tacrolimus was used for GVHD (Graft Versus Host Disease) prophylaxis. | Tacrolimus | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:06:16.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRTAC | ||||||||||||||||||||||||||
C58859 | Rash erythematous maculopapular indicate code | RashErythmatMaculopapIndCode | Code indicating whether the subject/participant had an erythmatous or maculopapular rash. | Code indicating whether the subject/participant had an erythmatous or maculopapular rash. |
Did the patient have an erythematous or maculopapular rash at the time of diagnosis? |
1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 12:33:22.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGRSDIAG | |||||||||||||||||||||||||||
C58891 | Biopsy perform suspect GVHD indicate code | BiopsyPerfrmSspctGVHDIndictCod | Code indicating whether any biopsies were performed for suspected GVHD (Graft Versus Host Disease). | Code indicating whether any biopsies were performed for suspected GVHD (Graft Versus Host Disease). | Were any biopsies performed during this assessment period for suspected GVHD? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
If yes, record the type, date, and result of any biopsies performed for suspected GVHD |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:35:05.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGBIOPSY | ||||||||||||||||||||||||||
C58748 | Aspartate aminotransferase sample date | ASTSampleDate | Date on which the aspartate aminotransferase (AST) sample was collected. | Date on which the aspartate aminotransferase (AST) sample was collected. | Date AST sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 09:11:55.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCASTDT | |||||||||||||||||||||||||||||
C58870 | Forced expiratory volume low measurement | FEV1LowMeasr | Lowest measurement of FEV1 (Forced Expiratory Volume) | Lowest measurement of FEV1 (Forced Expiratory Volume) | FEV1 | Numeric Values |
Record the lowest value during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 13:44:41.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
0 | 200 | percent | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFEV1VL | |||||||||||||||||||||||||
C58902 | Topical corticosteroid therapy chronic GVHD indicate code | TopCrtcstrdThpyChrnGVHDIndCode | Code indicating whether topical corticosteroid therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether topical corticosteroid therapy was used to treat chronic GVHD (graft-versus-host disease) | Topical Corticosteroids | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHTPCO | ||||||||||||||||||||||||||
C58838 | ATG use GVHD prophylaxis indicate code | ATGUseGVHDProphylaxisIndCode | Code indicating whether ATG was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether ATG was used for GVHD (Graft Versus Host Disease) prophylaxis. | ATG | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:06:16.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRATG | ||||||||||||||||||||||||||
C58881 | Alkaline phosphatase high measurement | AlklinPhosphatasHighMeasr | Highest measurement of alkaline phosphatase. | Highest measurement of alkaline phosphatase. | Highest alkaline phosphatase value | Numeric Values |
Record the highest value during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 10:51:09.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
0 | 9999 | unit per liter | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGALKPH | |||||||||||||||||||||||||
C58913 | Chloroquine phosphate therapy chronic GVHD indicate code | ChlrqnPhosThpyChrnGVHDIndCode | Code indicating whether Chloroquine phosphate therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether Chloroquine phosphate therapy was used to treat chronic GVHD (graft-versus-host disease) | Chloroquine Phosphate | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHCHPH | ||||||||||||||||||||||||||
C58849 | Other immunosuppressant use GVHD prophylaxis indicate code | OtImUseGVHDProphylaxisIndCode | Code indicating whether another immunosuppressant was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether another immunosuppressant was used for GVHD (Graft Versus Host Disease) prophylaxis. | Other immunosuppressant | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:06:16.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPROTHR | ||||||||||||||||||||||||||
C58860 | Diarrhea nausea vomit liver function abnormal present time diagnosis indicate code | DiaNauVomLivFnAbnPrTmDxIndCod | Code indicating whether any of the following were present at the time of diagnosis: diarrhea, nausea, vomiting, liver function abnormalities. | Code indicating whether any of the following were present at the time of diagnosis: diarrhea, nausea, vomiting, liver function abnormalities. | Was diarrhea, nausea, vomiting or liver function abnormalities present at the time of diagnosis? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 12:35:39.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGDRDIAG | |||||||||||||||||||||||||||
C58892 | Biopsy suspect GVHD type code | BiopsySuspectGVHDTypeCode | Code denoting the type of biopsy performed for suspected GVHD (Graft Versus Host Disease). | Code denoting the type of biopsy performed for suspected GVHD (Graft Versus Host Disease). | Type of biopsy performed for suspected GVHD | 1;2;3;4;5;6;7 | Skin biopsy;Oral biopsy;Upper GI biopsy;Lower GI biopsy;Liver biopsy;Lung biopsy;Other, specify | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:39:49.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGBIO1TY | |||||||||||||||||||||||||||
C58823 | Assessment period start date | AssessmentPeriodStartDate | Date of the beginning of the assessment period | Date of the beginning of the assessment period | Start of assessment period | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-12 15:06:29.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | DTPRVAST | |||||||||||||||||||||||||||||
C58871 | Forced expiratory volume 1 second measurement date | FEV1MeasurementDate | Date on which the FEV1 (forced expiratory volume in 1 second) measurement was taken | Date on which the FEV1 (forced expiratory volume in 1 second) measurement was taken | Date FEV1 obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 13:47:37.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFEV1DT | |||||||||||||||||||||||||||||
C58903 | Thalidomide therapy chronic GVHD indicate code | ThalidomidThpyChrnGVHDIndCode | Code indicating whether thalidomide therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether thalidomide therapy was used to treat chronic GVHD (graft-versus-host disease) | Thalidomide | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHTHAL | ||||||||||||||||||||||||||
C58839 | Bortezomib use GVHD prophylaxis indicate code | BorUseGVHDProphylaxisIndCode | Code indicating whether Bortezomib was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether Bortezomib was used for GVHD (Graft Versus Host Disease) prophylaxis. | Bortezomib | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:06:16.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRBORT | ||||||||||||||||||||||||||
C58882 | Alkaline phosphatase sample date | AlkalinPhosphatasSampleDate | Date on which sample was collected for alkaline phosphatase test. | Date on which sample was collected for alkaline phosphatase test. | Date alkaline phosphatase sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 10:53:01.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGAKPHDT | |||||||||||||||||||||||||||||
C58914 | In vivo anti T-lymphocyte monoclonal antibody therapy chronic GVHD indicate code | IVATLMAbThpyChrnGVHDIndCode | Code indicating whether in vivo anti T-lymphocyte monoclonal antibody therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether in vivo anti T-lymphocyte monoclonal antibody therapy was used to treat chronic GVHD (graft-versus-host disease) | In vivo anti T-lymphocyte monoclonal antibody | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHMAB | ||||||||||||||||||||||||||
C58850 | Other immunosuppressant use GVHD prophylaxis specify text | OtImUseGVHDProphylaxisSpfTxt | Free-text field related to 'Other immunosuppressant use GVHD prophylaxis indicate code' specifying the other immunosuppressant(s) used for GVHD (Graft Versus Host Disease) prophylaxis. | Free-text field related to 'Other immunosuppressant use GVHD prophylaxis indicate code' specifying the other immunosuppressant(s) used for GVHD (Graft Versus Host Disease) prophylaxis. | Specify other immunosuppressant agent used | Alphanumeric |
If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:06:16.0 | Follow Up/Chronic GVHD Form | sites | scdc | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPROTHR | |||||||||||||||||||||||||||
C58861 | Skin involvement GVHD extent code | SkinInvolvmntGVHDExtentCode | Code denoting the extent of skin involvement in GVHD (Graft Versus Host Disease) | Code denoting the extent of skin involvement in GVHD (Graft Versus Host Disease) | Extent of skin involvement | 0;1;2;3 | No symptoms;<18% body surface area with disease signs but no sclerotic features;19–50% body surface area or involvement with superficial sclerotic features not hidebound (able to pinch);>50% body surface area or deep sclerotic features hidebound or impaired mobility, ulceration, severe pruritis | Numeric Values |
Indicate the maximum severity of involvment during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 12:38:54.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGSKININV | ||||||||||||||||||||||||||
C58893 | Biopsy suspect GVHD type code other text | BiopsySuspectGVHDTypCodeOTH | The free-text field related to 'Biopsy suspect GVHD type code' specifying other text. | The free-text field related to 'Biopsy suspect GVHD type code' specifying other text. | If other type of biopsy, specify | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:44:30.0 | Follow Up/Chronic GVHD Form | sites | scdc | 50 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGBIO1SP | ||||||||||||||||||||||||||||
C58824 | Assessment period end date | AssessmentPeriodEndDate | Date of the end of the assessment period | Date of the end of the assessment period | End of assessment period | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-12 15:06:29.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | DTASSESS | |||||||||||||||||||||||||||||
C58872 | Forced vital capacity measurement | FVCMeasr | Measurement of the subject/participant's FVC (forced vital capacity) | Measurement of the subject/participant's FVC (forced vital capacity) | FVC | Numeric Values |
Record the value at the time of the lowest FEV1 measurement |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 13:55:00.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
0 | 200 | percent | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFVCVL | |||||||||||||||||||||||||
C58904 | Tacrolimus therapy chronic GVHD indicate code | TacrolimusThpyChrnGVHDIndCode | Code indicating whether Tacrolimus (F K 506, Prograf) therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether Tacrolimus (F K 506, Prograf) therapy was used to treat chronic GVHD (graft-versus-host disease) | Tacrolimus (FK 506, Prograf) | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHTAC | ||||||||||||||||||||||||||
C58840 | Campath use GVHD prophylaxis indicate code | CamUseGVHDProphylaxisIndCode | Code indicating whether Campath was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether Campath was used for GVHD (Graft Versus Host Disease) prophylaxis. | Campath | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:06:16.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRCAMP | ||||||||||||||||||||||||||
C58851 | GVHD prophylaxis discontinue date | GVHDProphlxsDiscontDate | Date on which GVHD (Graft Versus Host Disease) prophylaxis was discontinued. | Date on which GVHD (Graft Versus Host Disease) prophylaxis was discontinued. | If GVHD prophylaxis was discontinued during this assessment, record the date | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:26:03.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRDCDT | |||||||||||||||||||||||||||||
C58883 | Vaginitis non-infective status code | VaginitisNonInfectStatusCode | Code denoting the status of non-infective vaginitis exhibited by the participant/subject. | Code denoting the status of non-infective vaginitis exhibited by the participant/subject. | Non-infective vaginitis | 0;1;2;3 | No symptoms or not applicable;Mild, intervention not indicated;Moderate, intervention indicated;Severe, not relieved with treatment, ulceration | Numeric Values |
Indicate the maximum severity of involvment during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 10:59:31.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGVAGNIT | ||||||||||||||||||||||||||
C58916 | In vivo anti T-lymphocyte monoclonal antibody use specify text | InVvoAntTLymMAbUseSpcfyTxt | The free-text related to 'In vivo anti T-lymphocyte monoclonal antibody therapy chronic GVHD indicate code' for specifying the in vivo anti T-lymphocyte monoclonal antibody that was used to treat chronic GVHD (graft-versus-host disease) | The free-text related to 'In vivo anti T-lymphocyte monoclonal antibody therapy chronic GVHD indicate code' for specifying the in vivo anti T-lymphocyte monoclonal antibody that was used to treat chronic GVHD (graft-versus-host disease) |
Specify in vivo anti T-lymphocyte monoclonal antibody used to treat chronic GVHD |
Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 15:38:57.0 | Follow Up/Chronic GVHD Form | sites | scdc | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHMBSP | ||||||||||||||||||||||||||||
C58862 | Rash lichenoid present indicate code | RashLichenoidPresentIndCode | Code indicating whether lichenoid skin rash is present | Code indicating whether lichenoid skin rash is present | Lichenoid | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 12:47:02.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGRSLICH | |||||||||||||||||||||||||||
C58894 | Biopsy date | BiopsyDate | Date on which the biopsy was performed. | Date on which the biopsy was performed. | Date of biopsy | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:48:05.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGBIO1DT | |||||||||||||||||||||||||||||
C58825 | Acute GVHD maximum grade | AcuteGVHDMaximumGrade | Maximum overall grade of acute GVHD (Graft Versus Host Disease). | Maximum overall grade of acute GVHD (Graft Versus Host Disease). | Maximum overall grade of acute GVHD during this assessment period | 1;2;3;4;0 | I;II;III;IV;No symptoms of acute GVHD | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-12 15:11:06.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGGRAGVH | |||||||||||||||||||||||||||
C58873 | DLCO measurement | DLCOMeasr | Measurement of the subject/particpant's DLCO (diffusing capacity of the lung for carbon monoxide) | Measurement of the subject/particpant's DLCO (diffusing capacity of the lung for carbon monoxide) | DLCO | Numeric Values |
Record the value at the time of the lowest FEV1 measurement |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 13:57:52.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Free-Form Entry |
0 | 200 | percent | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGDLCOVL | |||||||||||||||||||||||||
C58905 | Mycophenolate Mofetil therapy chronic GVHD indicate code | MycoMofThpyChrnGVHDIndCode | Code indicating whether Mycophenolate Mofetil (MMF, Cellcept) therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether Mycophenolate Mofetil (MMF, Cellcept) therapy was used to treat chronic GVHD (graft-versus-host disease) | Mycophenolate Mofetil (MMF, Cellcept) | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHMMF | ||||||||||||||||||||||||||
C58841 | Cyclophosphamide use GVHD prophylaxis indicate code | CycUseGVHDProphylaxisIndCode | Code indicating whether Cyclophosphamide was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether Cyclophosphamide was used for GVHD (Graft Versus Host Disease) prophylaxis. | Cyclophosphamide | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:06:16.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRCYPH | ||||||||||||||||||||||||||
C58852 | Chronic GVHD severity maximum code | ChronGVHDSevertyMaxCode | Code denoting the maximum severity of the subject/participant's chronic GVHD (Graft Versus Host Disease) | Code denoting the maximum severity of the subject/participant's chronic GVHD (Graft Versus Host Disease) |
Maximum overall severity of chronic GVHD during this assessment period |
0;1;2;3 | No chronic GVHD;Mild;Moderate;Severe | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:34:03.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGSVCGVH | |||||||||||||||||||||||||||
C58884 | Joint contracture status code | JointContractureStatusCode | Code denoting the status of the subject/participant's joint contractures | Code denoting the status of the subject/participant's joint contractures | Contractures | 0;1;2;3 | No symptoms/undefined;Mild joint contractures;Moderate joint contractures;Severe joint contractures | Numeric Values |
Indicate the maximum severity of involvment during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:04:49.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGCONTRC | ||||||||||||||||||||||||||
C58918 | In vivo immunotoxin therapy chronic GVHD indicate code | IVImntxnThpyChrnGVHDIndCode | Code indicating whether in vivo immunotoxin therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether in vivo immunotoxin therapy was used to treat chronic GVHD (graft-versus-host disease) | In Vivo Immunotoxin | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHIMM | ||||||||||||||||||||||||||
C58863 | Rash maculopapular present indicate code | RashMaculopaplrPresentIndCode | Code indicating whether maculopapular skin rash is present | Code indicating whether maculopapular skin rash is present | Maculopapular | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 12:47:02.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGRSMACU | |||||||||||||||||||||||||||
C58895 | Biopsy suspect GVHD result code | BiopsySuspectGVHDResltCode | Code denoting the result of the biopsy performed for suspected GVHD (Graft Versus Host Disease) | Code denoting the result of the biopsy performed for suspected GVHD (Graft Versus Host Disease) | Result of biopsy performed for suspected GVHD | 1;2;3 | Positive GVHD;Negative GVHD;Equivocal | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:49:53.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGBIO1RS | |||||||||||||||||||||||||||
C58826 | Acute GVHD sign symptom new develop indicate code | AcutGVHDSgnSymNwDvlpIndCode | Code indicating whether new signs or symptoms of acute GVHD (Graft Versus Host Disease) have developed. | Code indicating whether new signs or symptoms of acute GVHD (Graft Versus Host Disease) have developed. | Did new clinical signs and/or symptoms of acute GVHD develop during this assessment period? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Only report new clinical signs and/or symptoms of acute GVHD that developed during the assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-12 15:15:50.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGAGVDVL | ||||||||||||||||||||||||||
C58874 | Esophagus GVHD status code | EsophagusGVHDStatusCode | Code denoting the status of the subject/participant's esophagus when suffering from GVHD (Graft Versus Host Disease). | Code denoting the status of the subject/participant's esophagus when suffering from GVHD (Graft Versus Host Disease). | Esophagus | 0;1 | No symptoms;Symptoms, confirmed with diagnostic procedure | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 14:31:57.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGESOPH | |||||||||||||||||||||||||||
C58906 | PUVA therapy chronic GVHD indicate code | PUVAThpyChrnGVHDIndCode | Code indicating whether PUVA (Psoralen and ultraviolet A) therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether PUVA (Psoralen and ultraviolet A) therapy was used to treat chronic GVHD (graft-versus-host disease) | PUVA (Psoralen and UVA) | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHPUVA | ||||||||||||||||||||||||||
C58842 | Cyclosporine use GVHD prophylaxis indicate code | CylUseGVHDProphylaxisIndCode | Code indicating whether Cyclosporine was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether Cyclosporine was used for GVHD (Graft Versus Host Disease) prophylaxis. | Cyclosporine | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis |
Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:06:16.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRCYCL | ||||||||||||||||||||||||||
C58853 | Chronic GVHD sign symptom new develop indicate code | ChronGVHDSgnSympNwDevIndCode | Code indicating whether new signs or symptoms of chronic GVHD (Graft Versus Host Disease) have developed | Code indicating whether new signs or symptoms of chronic GVHD (Graft Versus Host Disease) have developed |
Did new clinical signs and/or symptoms of chronic GVHD develop during this assessment period? |
1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:43:07.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGCGVDVL | |||||||||||||||||||||||||||
C58885 | Myositis present indicate code | MyositisPresntIndicatCode | Code indicating whether myositis is present in the subject/participant | Code indicating whether myositis is present in the subject/participant | Myositis | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:08:02.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGMYOSIT | |||||||||||||||||||||||||||
C58920 | In vivo immunotoxin use specify text | InVvoImmuntoxnUseSpcfyTxt | The free-text related to 'In vivo immunotoxin therapy chronic GVHD indicate code' for specifying the in vivo immunotoxin that was used to treat chronic GVHD (graft-versus-host disease) | The free-text related to 'In vivo immunotoxin therapy chronic GVHD indicate code' for specifying the in vivo immunotoxin that was used to treat chronic GVHD (graft-versus-host disease) | Specify in vivo immunotoxin used to treat chronic GVHD | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 15:38:57.0 | Follow Up/Chronic GVHD Form | sites | scdc | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHIMSP | ||||||||||||||||||||||||||||
C58864 | Rash sclerodermatous present indicate code | RashSclrodrmatusPresentIndCode | Code indicating whether sclerodermatous skin rash is present | Code indicating whether sclerodermatous skin rash is present | Sclerodermatous | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 12:47:02.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGRSMACU | |||||||||||||||||||||||||||
C58896 | Therapy treat chronic GVHD indicate code | TherpyTretChronGVHDIndicatCode | Code indicating whether a specific therapy was used to treat chronic GVHD (Graft Versus Host Disease) | Code indicating whether a specific therapy was used to treat chronic GVHD (Graft Versus Host Disease) | Was a specific therapy used to treat chronic GVHD during this assessment period? | 1;2;3 | Yes, initiated this assessment period;Yes, continuing from previous assessment period;No | Numeric Values |
Therapies used for GVHD prophylaxis should not be recorded here. Only report therapies that were initiated during this assessment period. Treatment is defined as increasing the dose of an ongoing agent or addition of a new agent. Adjusting a drug taper does not qualify as treatment. |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:55:43.0 | Follow Up/Chronic GVHD Form | sites | scdc |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGCHRTRT |