CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Disease Related Events
CRF: Follow Up

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
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event 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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event 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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRCAMP
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event 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 Disease Related Events History of Disease Event

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRDCDT
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRCYPH
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGSVCGVH
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRCYCL
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event 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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGCGVDVL
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGCHRTRT
C58827 Acute GVHD diagnosis date AcuteGVHDDiagnosisDate Date of diagnosis of acute GVHD (Graft Versus Host Disease) Date of diagnosis of acute GVHD (Graft Versus Host Disease) Date of diagnosis of acute GVHD Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 15:18:08.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGAGDGDT
C58875 Nausea vomit GVHD status code NauseaVomitGVHDStatusCode Code denoting the nausea/vomiting status of the subject/participant with GVHD (Graft Versus Host Disease) Code denoting the nausea/vomiting status of the subject/participant with GVHD (Graft Versus Host Disease) Nausea and vomiting 1;0 Persistent nausea, vomiting or anorexia;No protracted nausea and vomiting Numeric Values

Indicate the maximum severity of involvment during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-14 14:35:32.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGNAUSVM
C58907 ECP therapy chronic GVHD indicate code ECPThpyChrnGVHDIndCode Code indicating whether ECP (Extra-corporeal photopheresis) therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether ECP (Extra-corporeal photopheresis) therapy was used to treat chronic GVHD (graft-versus-host disease) ECP (Extra-corporeal Photopheresis) 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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHECP
C58843 MMF use GVHD prophylaxis indicate code MMFUseGVHDProphylaxisIndCode Code indicating whether MMF was used for GVHD (Graft Versus Host Disease) prophylaxis. Code indicating whether MMF was used for GVHD (Graft Versus Host Disease) prophylaxis. MMF 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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRMMF
C58886 Eosinophilia present indicate code EosinphiliaPresntIndicatCode Code indicating whether eosinophilia is present in the subject/participant. Code indicating whether eosinophilia is present in the subject/participant. Eosinophilia 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-17 11:11:17.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGEOSINP
C58921 Other agent therapy chronic GVHD indicate code OthAgntThpyChrnGVHDIndCode Code indicating whether therapy using another agent was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether therapy using another agent was used to treat chronic GVHD (graft-versus-host disease) Was another agent used to treat chronic GVHD? 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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHOTHR
C58854 Chronic GVHD diagnosis onset initial date ChronGVHDDxOnsetInitlDate Date of initial diagnosis or onset of chronic GVHD (Graft Versus Host Disease). Date of initial diagnosis or onset of chronic GVHD (Graft Versus Host Disease). Date of initial diagnosis/onset of chronic GVHD Date or Date & Time

Only initial diagnosis or onset of chronic GVHD should be reported

Adult;Pediatric Proposed 1.00 2018-12-14 11:46:11.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGCGDGDT
C58865 Rash other type present indicate code RashOthrTypPresentIndCode Code indicating whether another type of skin rash is present Code indicating whether another type of skin rash is present Other type of rash 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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGRSMACU
C58897 Chronic GVHD treatment initiate date ChronGVHDTreatinitiatDate Date on which therapy for treatment of chronic GVHD (Graft Versus Host Disease) was initiated. Date on which therapy for treatment of chronic GVHD (Graft Versus Host Disease) was initiated. Date chronic GVHD treatment initiated Date or Date & Time

If the date is out of range because the therapy was initiated during a previous assessment period, it should be entered on the previous form.

Adult;Pediatric Proposed 1.00 2018-12-17 12:00:36.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGCTRDT
C58828 Skin abnormality severity at acute GVHD maximum overall grade code SknAbnSvrAtActGVHDMaxOvlGrdCod Code for the highest severity of skin abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) Code for the highest severity of skin abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) Skin abnormalities 0;1;2;3;4 No rash;Maculopapular rash, <25% of body surface;Maculopapular rash, 25–50% of body surface;Generalized erythrodema;Generalized erythrodema with bullus formation and desquamation 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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGASKNAB
C58876 Diarrhea persistence GVHD code DiarrheaPersistenceGVHDCode Code denoting the persistence of diarrhea for the subject/participant with GVHD (Graft Versus Host Disease) Code denoting the persistence of diarrhea for the subject/participant with GVHD (Graft Versus Host Disease) Diarrhea 0;1;2 None;Persisting less than 2 weeks;Persisting more than 2 weeks Numeric Values

Indicate the maximum severity of involvment during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-14 14:40:11.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDIARH
C58908 Sirolimus therapy chronic GVHD indicate code SirolimusThpyChrnGVHDIndCode Code indicating whether Sirolimus (Rapamycin) therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether Sirolimus (Rapamycin) therapy was used to treat chronic GVHD (graft-versus-host disease) Sirolimus (Rapamycin) 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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHSIR
Displaying 1 - 50 of 96
CSV