Sub-Domain: Treatment/Intervention Data
CRF: themes
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
0 | 9999 | unit per liter | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGAST | |||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCASTDT | |||||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGRSDIAG | |||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRATG | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
0 | 200 | percent | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFEV1VL | |||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPROTHR | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
0 | 9999 | unit per liter | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGALKPH | |||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | DTPRVAST | |||||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGDRDIAG | |||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRBORT | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFEV1DT | |||||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPROTHR | |||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGAKPHDT | |||||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites | 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 | Treatment/Intervention Data | sites |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | DTASSESS | |||||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGSKININV | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRCAMP | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
0 | 200 | percent | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFVCVL | |||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHMBSP | ||||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRDCDT | |||||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGGRAGVH | |||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGRSLICH | |||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRCYPH | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Free-Form Entry |
0 | 200 | percent | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGDLCOVL | |||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHIMM | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGSVCGVH | |||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGAGVDVL | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGRSMACU | |||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRCYCL | ||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGESOPH | |||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
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 | Treatment/Intervention Data | sites | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHIMSP | ||||||||||||||||||||||||||||
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 | Treatment/Intervention Data | sites |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGCGVDVL |