Sub-Domain: Disease Related Events
CRF:
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | 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 | Disease Related Events | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | 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 | Disease Related Events | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | 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 | Disease Related Events | general-data-protection-regulation-gdpr |
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 | 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 | Disease Related Events | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr | 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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
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 | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHSIR | ||||||||||||||||||||||||||
C58844 | Maraviroc use GVHD prophylaxis indicate code | MarUseGVHDProphylaxisIndCode | Code indicating whether Maraviroc was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether Maraviroc was used for GVHD (Graft Versus Host Disease) prophylaxis. | Maraviroc | 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 | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRMRVR | ||||||||||||||||||||||||||
C58887 | Serositis present indicate code | SerositisPresentIndicatCode | Code indicating whether serositis is present in the subject/participant. | Code indicating whether serositis is present in the subject/participant. | Serositis | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:14:02.0 | Follow Up/Chronic GVHD Form | Disease Related Events | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGSEROS | |||||||||||||||||||||||||||
C58922 | Other agent use treat GVHD specify text | OthAgntUseTrtGVHDSpcfyTxt | The free-text related to 'Other agent therapy chronic GVHD indicate code' for specifying the other agent that was used to treat chronic GVHD (graft-versus-host disease) | The free-text related to 'Other agent therapy chronic GVHD indicate code' for specifying the other agent that was used to treat chronic GVHD (graft-versus-host disease) | Specify other agent 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 | general-data-protection-regulation-gdpr | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHOTSP | ||||||||||||||||||||||||||||
C58855 | Karnofsky Lansky minimum score code | KarnLanMinScorCode | Code denoting the minimum score on the Karnofsky or Lansky scale. | Code denoting the minimum score on the Karnofsky or Lansky scale. | Minimum Karnofsky/Lansky Score at time of diagnosis | 02;03;04;05;06;07;08;09;10;01 | 90 (Normal Activity/Minor Restriction in Strenuous Play);80 (Normal Activity with Effort/Restricted in Strenuous Play);70 (Unable to Carry On Normal Activity/Less Time Spent in Play);60 (Requires Occasional Assistance/Minimal Active Play);50 (Requires Considerable Assistance/No Active Play);40 (Disabled/Able to Initiate Quiet Activities);30 (Severely Disabled/Needs Assistance for Quiet Play);20 (Very Sick/Limited to Very Passive Activity);10 (Moribund, Completely Disabled);100 (Normal, No Complaints/Fully Active) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 11:50:05.0 | Follow Up/Chronic GVHD Form | Disease Related Events | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGDGKNLN | |||||||||||||||||||||||||||
C58866 | Rash other type present specify text | RashOthrTypPresentSpcfyTxt | Free-text field related to 'Rash other type present indicate code' for specifying the type of rash present. | Free-text field related to 'Rash other type present indicate code' for specifying the type of rash present. | Specify other rash | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 13:11:51.0 | Follow Up/Chronic GVHD Form | Disease Related Events | general-data-protection-regulation-gdpr | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGRSOTSP | ||||||||||||||||||||||||||||
C58898 | ALS ALG ATS ATG therapy chronic GVHD indicate code | ALSALGATSATGThpyChrnGVHDIndCod | Code indicating whether any of the following therapies were used to treat chronic GVHD (graft-versus-host disease): anti-lymphocytic serum (ALS), anti-lymphocyte globulin (ALG), anti-thymocyte serum (ATS), anti-thymocyte globulin (ATG) | Code indicating whether any of the following therapies were used to treat chronic GVHD (graft-versus-host disease): anti-lymphocytic serum (ALS), anti-lymphocyte globulin (ALG), anti-thymocyte serum (ATS), anti-thymocyte globulin (ATG) | ALS, ALG, ATS, ATG | 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 | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHATG | ||||||||||||||||||||||||||
C58829 | Upper GI abnormality severity at acute GVHD maximum overall grade code | UGIAbnSvrAtActGVHDMaxOvlGrdCod | Code for the highest severity of upper GI (gastrointestinal tract) abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) | Code for the highest severity of upper GI (gastrointestinal tract) abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) | Upper GI abnormalities | 1;0 | Persistent nausea, vomiting or anorexia;No protracted nausea and vomiting | 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 | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGAUGIAB | ||||||||||||||||||||||||||
C58877 | Bilirubin high measurement | BilirubinHighMeasr | Highest measurement of bilirubin (method unspecified), in milligrams per deciliter | Highest measurement of bilirubin (method unspecified), in milligrams per deciliter | Highest bilirubin value | Numeric Values |
Record the highest value during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 10:35:20.0 | Follow Up/Chronic GVHD Form | Disease Related Events | 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) | FGBILI | |||||||||||||||||||||||||
C58909 | Etretinate therapy chronic GVHD indicate code | EtretinateThpyChrnGVHDIndCode | Code indicating whether Etretinate therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether Etretinate therapy was used to treat chronic GVHD (graft-versus-host disease) | Etretinate | 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 | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHETR | ||||||||||||||||||||||||||
C58845 | Methotrexate use GVHD prophylaxis indicate code | MethUseGVHDProphylaxisIndCode | Code indicating whether Methotrexate was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether Methotrexate was used for GVHD (Graft Versus Host Disease) prophylaxis. | Methotrexate | 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 | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRMTRX |