CDE Detailed Report
Disease:
Sub-Domain: Treatment/Intervention Data
CRF:

Displaying 1 - 50 of 96
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
C58900 Cyclosporine therapy chronic GVHD indicate code CyclosporinThpyChrnGVHDIndCode Code indicating whether Cyclosporine therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether Cyclosporine therapy was used to treat chronic GVHD (graft-versus-host disease) Cyclosporine 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 general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHCYCL
C58834 Liver abnormality severity at acute GVHD maximum overall grade code LvrAbnSvrAtActGVHDMaxOvlGrdCod Code for the highest severity of liver abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) Code for the highest severity of liver abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) Liver abnormalities 0;1;2;3;4 Bilirubin <2.0 mg/dL;Bilirubin 2.0–3.0 mg/dL;Bilirubin 3.1–6.0 mg/dL;Bilirubin 6.1–15.0 mg/dL;Bilirubin >15.0 mg/dL Numeric Values

Record the highest severity for the organ system at the time of maximum overall grade of acute GVHD

Adult;Pediatric Proposed 1.00 2018-12-12 15:24:41.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGALVRAB
C58868 Mucositis oral ulcer functional status code MucostsOralUlcrFunclStatCode Code denoting the functional status of the subject/participant's mucositis or oral ulcers. Code denoting the functional status of the subject/participant's mucositis or oral ulcers. Mucositis/ulcers (functional) 0;1;2;3 No symptoms;Minimal symptoms, normal diet;Symptomatic but can eat and swallow modified diet;Symptomatic and unable to adequately aliment or hydrate orally Numeric Values

Indicate the maximum severity of involvment during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-14 13:32:52.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGMUCOS
C58911 Etanercept therapy chronic GVHD indicate code EtanerceptThpyChrnGVHDIndCode Code indicating whether Etanercept therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether Etanercept therapy was used to treat chronic GVHD (graft-versus-host disease) Etanercept 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 general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHETAN
C58847 Sirolimus use GVHD prophylaxis indicate code SiroUseGVHDProphylaxisIndCode Code indicating whether Sirolimus was used for GVHD (Graft Versus Host Disease) prophylaxis. Code indicating whether Sirolimus was used for GVHD (Graft Versus Host Disease) prophylaxis. Sirolimus 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 general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRSIR
C58879 Alanine aminotransferase high measurement ALTHighMeasr Highest measurement of ALT (alanine aminotransferase). Highest measurement of ALT (alanine aminotransferase). Highest ALT 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 general-data-protection-regulation-gdpr

Free-Form Entry

0 9999 unit per liter BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGALT
C58890 Other organ involve GVHD specify text OthrOrgnInvolvGVHDSpcfyTxt The free-text field related to 'Other organ involve GVHD indicate code' for specifying other organs involved. The free-text field related to 'Other organ involve GVHD indicate code' for specifying other organs involved. Specify other organ involvement in chronic GVHD Alphanumeric Adult;Pediatric Proposed 1.00 2018-12-17 11:30:10.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data general-data-protection-regulation-gdpr 100

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGOTORSP
C58746 Alanine aminotransferase sample date ALTSampleDate Date on which the alanine aminotransferase (ALT) sample was collected. Date on which the alanine aminotransferase (ALT) sample was collected. Date ALT 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 general-data-protection-regulation-gdpr

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCALTDT
C58858 Bilirubin total measurement BilirubinTotalMeasr Measurement in milligrams per deciliter of total bilirubin Measurement in milligrams per deciliter of total bilirubin Total bilirubin at time of diagnosis Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 12:31:12.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data general-data-protection-regulation-gdpr

Free-Form Entry

0 99.9 milligram per deciliter BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDGBILI
C58901 Systemic corticosteroid therapy chronic GVHD indicate code SysCrtcstrdThpyChrnGVHDIndCode Code indicating whether systemic corticosteroid therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether systemic corticosteroid therapy was used to treat chronic GVHD (graft-versus-host disease) Systemic 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 general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHSYCO
C58837 Prophylaxis GVHD given during assessment period code PrphylxGVHDGivDurAssessPrdCode Code for whether prophylaxis for GVHD (Graft Versus Host Disease) was given to the subject/participant during the assessment period. Code for whether prophylaxis for GVHD (Graft Versus Host Disease) was given to the subject/participant during the assessment period. Was prophylaxis for GVHD given during this assessment
period?
1;2;3 Yes;No;Discontinued during this assessment period Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 15:44:33.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPROPIM
C58869 Bronchiolitis obliterans status code BronchioltsObliternsStatusCode Code denoting the status of the subject/participant's bronchiolitis obliterans Code denoting the status of the subject/participant's bronchiolitis obliterans Bronchiolitis obliterans 1;2;3;4 Yes, histologic diagnosis;Yes, clinical diagnosis;No;Unknown Numeric Values

Indicate the maximum severity of involvment during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-14 13:37:50.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGBRNCH
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 Treatment/Intervention Data general-data-protection-regulation-gdpr

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 Treatment/Intervention Data general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRTAC
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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr 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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr 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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

Free-Form Entry

0 200 percent BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGFVCVL
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 general-data-protection-regulation-gdpr 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 general-data-protection-regulation-gdpr

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 Treatment/Intervention Data general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGVAGNIT
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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

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 general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHIMM
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