CDE Detailed Report
Disease: cookie-policy
Sub-Domain: Treatment%2FIntervention Data
CRF:
Sub-Domain: Treatment%2FIntervention Data
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C58878 | Bilirubin measurement sample date | BilirubinMeasrSampleDate | Date bilirubin sample was collected for testing. | Date bilirubin sample was collected for testing. | Date bilirubin sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 10:41:01.0 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGBILIDT | |||||||||||||||||||||||||||||
| C58910 | Lamprene therapy chronic GVHD indicate code | LampreneThpyChrnGVHDIndCode | Code indicating whether Lamprene therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether Lamprene therapy was used to treat chronic GVHD (graft-versus-host disease) | Lamprene | 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGTHLAMP | ||||||||||||||||||||||||||
| C58846 | Prednisone use GVHD prophylaxis indicate code | PredUseGVHDProphylaxisIndCode | Code indicating whether Prednisone was used for GVHD (Graft Versus Host Disease) prophylaxis. | Code indicating whether Prednisone was used for GVHD (Graft Versus Host Disease) prophylaxis. | Prednisone | 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRPRED | ||||||||||||||||||||||||||
| C58889 | Other organ involve GVHD indicate code | OthOrganInvolvGVHDIndicatCode | Code indicating whether other organs not specified were involved with the subject/participant's GVHD (Graft Versus Host Disease). | Code indicating whether other organs not specified were involved with the subject/participant's GVHD (Graft Versus Host Disease). | Was there any other organ involvement in chronic GVHD? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:17:43.0 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGOTORGN | |||||||||||||||||||||||||||
| C18027 | Comment text | CmmntTxt | Provide any additional information that pertains to the question. | Provide any additional information that pertains to the question. | Comments | Alphanumeric | Adult;Pediatric | Proposed | 3.00 | 2013-07-16 14:01:43.01 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant | 4000 |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C58857 | Alkaline phosphatase time diagnosis measurement | AlkPhosphtaseTimDxMeasr | Measurement in units per liter of alkaline phosphatase at the time of diagnosis | Measurement in units per liter of alkaline phosphatase at the time of diagnosis | Alkaline phosphatase at time of diagnosis | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-14 12:27:04.0 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
0 | 9999 | unit per liter | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGDGALKP | ||||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGMUCOS | ||||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
0 | 9999 | unit per liter | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGALT | |||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRSIR | ||||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant | 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGBRNCH | ||||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
0 | 9999 | unit per liter | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGAST | |||||||||||||||||||||||||
| C58912 | Zenapax therapy chronic GVHD indicate code | ZenapaxThpyChrnGVHDIndCode | Code indicating whether Zenapax (Daclizumab) therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether Zenapax (Daclizumab) therapy was used to treat chronic GVHD (graft-versus-host disease) | Zenapax (Daclizumab) | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRTAC | ||||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
0 | 200 | percent | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFEV1VL | |||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
0 | 9999 | unit per liter | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGALKPH | |||||||||||||||||||||||||
| C58913 | Chloroquine phosphate therapy chronic GVHD indicate code | ChlrqnPhosThpyChrnGVHDIndCode | Code indicating whether Chloroquine phosphate therapy was used to treat chronic GVHD (graft-versus-host disease) | Code indicating whether Chloroquine phosphate therapy was used to treat chronic GVHD (graft-versus-host disease) | Chloroquine Phosphate | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate whether the agent listed was used to treat chronic GVHD during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 12:03:21.0 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPROTHR | ||||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFEV1DT | |||||||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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 | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPROTHR | |||||||||||||||||||||||||||
| 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%2FIntervention Data | Transplantation%2FStem Cell Transplant | 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
0 | 200 | percent | BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGFVCVL | |||||||||||||||||||||||||
| C58883 | Vaginitis non-infective status code | VaginitisNonInfectStatusCode | Code denoting the status of non-infective vaginitis exhibited by the participant/subject. | Code denoting the status of non-infective vaginitis exhibited by the participant/subject. | Non-infective vaginitis | 0;1;2;3 | No symptoms or not applicable;Mild, intervention not indicated;Moderate, intervention indicated;Severe, not relieved with treatment, ulceration | Numeric Values |
Indicate the maximum severity of involvment during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2018-12-17 10:59:31.0 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGVAGNIT | ||||||||||||||||||||||||||
| C58916 | In vivo anti T-lymphocyte monoclonal antibody use specify text | InVvoAntTLymMAbUseSpcfyTxt | The free-text related to 'In vivo anti T-lymphocyte monoclonal antibody therapy chronic GVHD indicate code' for specifying the in vivo anti T-lymphocyte monoclonal antibody that was used to treat chronic GVHD (graft-versus-host disease) | The free-text related to 'In vivo anti T-lymphocyte monoclonal antibody therapy chronic GVHD indicate code' for specifying the in vivo anti T-lymphocyte monoclonal antibody that was used to treat chronic GVHD (graft-versus-host disease) |
Specify in vivo anti T-lymphocyte monoclonal antibody used to treat chronic GVHD |
Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 15:38:57.0 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant | 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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGPRDCDT | |||||||||||||||||||||||||||||
| C58894 | Biopsy date | BiopsyDate | Date on which the biopsy was performed. | Date on which the biopsy was performed. | Date of biopsy | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-17 11:48:05.0 | Follow Up/Chronic GVHD Form | Treatment%2FIntervention Data | Transplantation%2FStem Cell Transplant |
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%2FIntervention Data | Transplantation%2FStem Cell Transplant |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Follow Up/Chronic GVHD Form (FGV) | FGGRAGVH |