CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Treatment/Intervention Data
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
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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRMRVR
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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHSIR
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 Treatment/Intervention Data Transplantation/Stem Cell Transplant 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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDGKNLN
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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGSEROS
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 Treatment/Intervention Data Transplantation/Stem Cell Transplant 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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGAUGIAB
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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRMTRX
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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHETR
C58856 Platelet minimum time diagnosis count PlateletMinTimDxCt Minimum count of platelets per cubic millimeter at the time of diagnosis. Minimum count of platelets per cubic millimeter at the time of diagnosis. Minimum platelet count at time of diagnosis Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 12:23:41.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Free-Form Entry

0 999999 cubic millimeter BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDGPLT
C58888 Fascitis present indicate code FascitisPresentIndicateCode Code indicating whether fascitis is present in the subject/participant. Code indicating whether fascitis is present in the subject/participant. Fascitis 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-17 11:15:19.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGFASCIT
C01541 Weight measurement WgtMeasr Measurement of participant's/subject's weight Measurement of participant's/subject's weight Weight at time of diagnosis Numeric Values Adult;Pediatric Proposed 3.00 2013-07-25 08:54:08.2 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Free-Form Entry

0 500 kilogram DeBaun Forms
C58830 Lower GI abnormality severity at acute GVHD maximum overall grade code LGIAbnSvrAtActGVHDMaxOvlGrdCod Code for the highest severity of lower GI (gastrointestinal tract) abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) Code for the highest severity of lower GI (gastrointestinal tract) abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) Lower GI abnormalities 0;1;2;3;4;5 No diarrhea;Diarrhea less than or equal to 500 mL/day or <280 mL/m^2;Diarrhea >500 but less than or equal to 1000 mL/day or 280–555 mL/m^2;Diarrhea >1000 but less than or equal to 1500 mL/day or 556–833 mL/m^2;Diarrhea >1500 mL/day or >833 mL/m^2;Severe abdominal pain with or without ileus, or stool with frank blood or melena Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-12 15:24:41.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGALGIAB
C58867 Xerophthalmia status code XerophthalmiaStatusCode Code denoting the degree of xerophthalmia exhibited by the subject/participant. Code denoting the degree of xerophthalmia exhibited by the subject/participant. Xerophthalmia 0;1;2 No symptoms;Dry eyes but not requiring therapy;Dryness of eyes or inflammation requiring therapy Numeric Values

Indicate the maximum severity of involvment during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-14 13:22:37.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGXEROPH
C58899 Azathiapine therapy chronic GVHD indicate code AzathiapinThpyChrnGVHDIndCode Code indicating whether Azathiapine therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether Azathiapine therapy was used to treat chronic GVHD (graft-versus-host disease) Azathioprine 1;2;1;2 Yes;No;Yes;No Numeric Values

Indicate whether the agent listed was used to treat chronic GVHD during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHAZAT
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/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRPRED
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/Intervention Data Transplantation/Stem 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/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHLAMP
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/Intervention Data Transplantation/Stem Cell Transplant

Free-Form Entry

0 9999 unit per liter BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDGALKP
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/Intervention Data Transplantation/Stem 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/Intervention Data Transplantation/Stem Cell Transplant 4000

Free-Form Entry

DeBaun Forms
C58834 Liver abnormality severity at acute GVHD maximum overall grade code LvrAbnSvrAtActGVHDMaxOvlGrdCod Code for the highest severity of liver abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) Code for the highest severity of liver abnormalities at the time of the maximum overall grade of GVHD (Graft Versus Host Disease) Liver abnormalities 0;1;2;3;4 Bilirubin <2.0 mg/dL;Bilirubin 2.0–3.0 mg/dL;Bilirubin 3.1–6.0 mg/dL;Bilirubin 6.1–15.0 mg/dL;Bilirubin >15.0 mg/dL Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-12 15:24:41.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem 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/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGMUCOS
C58900 Cyclosporine therapy chronic GVHD indicate code CyclosporinThpyChrnGVHDIndCode Code indicating whether Cyclosporine therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether Cyclosporine therapy was used to treat chronic GVHD (graft-versus-host disease) Cyclosporine 1;2;1;2 Yes;No;Yes;No Numeric Values

Indicate whether the agent listed was used to treat chronic GVHD during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHCYCL
C58847 Sirolimus use GVHD prophylaxis indicate code SiroUseGVHDProphylaxisIndCode Code indicating whether Sirolimus was used for GVHD (Graft Versus Host Disease) prophylaxis. Code indicating whether Sirolimus was used for GVHD (Graft Versus Host Disease) prophylaxis. Sirolimus 1;2;1;2 Yes;No;Yes;No Numeric Values

If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis

Adult;Pediatric Proposed 1.00 2018-12-14 11:06:16.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRSIR
C58879 Alanine aminotransferase high measurement ALTHighMeasr Highest measurement of ALT (alanine aminotransferase). Highest measurement of ALT (alanine aminotransferase). Highest ALT value Numeric Values

Record the highest value during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-17 10:46:11.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem 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/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHETAN
C58858 Bilirubin total measurement BilirubinTotalMeasr Measurement in milligrams per deciliter of total bilirubin Measurement in milligrams per deciliter of total bilirubin Total bilirubin at time of diagnosis Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 12:31:12.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Free-Form Entry

0 99.9 milligram per deciliter BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDGBILI
C58890 Other organ involve GVHD specify text OthrOrgnInvolvGVHDSpcfyTxt The free-text field related to 'Other organ involve GVHD indicate code' for specifying other organs involved. The free-text field related to 'Other organ involve GVHD indicate code' for specifying other organs involved. Specify other organ involvement in chronic GVHD Alphanumeric Adult;Pediatric Proposed 1.00 2018-12-17 11:30:10.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem 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/Intervention Data Transplantation/Stem Cell Transplant

Free-Form Entry

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGBRNCH
C58901 Systemic corticosteroid therapy chronic GVHD indicate code SysCrtcstrdThpyChrnGVHDIndCode Code indicating whether systemic corticosteroid therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether systemic corticosteroid therapy was used to treat chronic GVHD (graft-versus-host disease) Systemic Corticosteroids 1;2;1;2 Yes;No;Yes;No Numeric Values

Indicate whether the agent listed was used to treat chronic GVHD during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHSYCO
C58848 Tacrolimus use GVHD prophylaxis indicate code TacrUseGVHDProphylaxisIndCode Code indicating whether Tacrolimus was used for GVHD (Graft Versus Host Disease) prophylaxis. Code indicating whether Tacrolimus was used for GVHD (Graft Versus Host Disease) prophylaxis. Tacrolimus 1;2;1;2 Yes;No;Yes;No Numeric Values

If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis

Adult;Pediatric Proposed 1.00 2018-12-14 11:06:16.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRTAC
C58880 Aspartate aminotransferase high measurement ASTHighMeasr Highest measurement of AST (aspartate aminotransferase). Highest measurement of AST (aspartate aminotransferase). Highest AST value Numeric Values

Record the highest value during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-17 10:46:11.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem 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/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHZENA
C58859 Rash erythematous maculopapular indicate code RashErythmatMaculopapIndCode Code indicating whether the subject/participant had an erythmatous or maculopapular rash. Code indicating whether the subject/participant had an erythmatous or maculopapular rash. Did the patient have an erythematous or maculopapular
rash at the time of diagnosis?
1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 12:33:22.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGRSDIAG
C58891 Biopsy perform suspect GVHD indicate code BiopsyPerfrmSspctGVHDIndictCod Code indicating whether any biopsies were performed for suspected GVHD (Graft Versus Host Disease). Code indicating whether any biopsies were performed for suspected GVHD (Graft Versus Host Disease). Were any biopsies performed during this assessment period for suspected GVHD? 1;2;1;2 Yes;No;Yes;No Numeric Values

If yes, record the type, date, and result of any biopsies performed for suspected GVHD

Adult;Pediatric Proposed 1.00 2018-12-17 11:35:05.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem 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/Intervention Data Transplantation/Stem Cell Transplant

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCASTDT
C58838 ATG use GVHD prophylaxis indicate code ATGUseGVHDProphylaxisIndCode Code indicating whether ATG was used for GVHD (Graft Versus Host Disease) prophylaxis. Code indicating whether ATG was used for GVHD (Graft Versus Host Disease) prophylaxis. ATG 1;2;1;2 Yes;No;Yes;No Numeric Values

If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis

Adult;Pediatric Proposed 1.00 2018-12-14 11:06:16.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem 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/Intervention Data Transplantation/Stem Cell Transplant

Free-Form Entry

0 200 percent BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGFEV1VL
C58902 Topical corticosteroid therapy chronic GVHD indicate code TopCrtcstrdThpyChrnGVHDIndCode Code indicating whether topical corticosteroid therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether topical corticosteroid therapy was used to treat chronic GVHD (graft-versus-host disease) Topical Corticosteroids 1;2;1;2 Yes;No;Yes;No Numeric Values

Indicate whether the agent listed was used to treat chronic GVHD during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHTPCO
C58849 Other immunosuppressant use GVHD prophylaxis indicate code OtImUseGVHDProphylaxisIndCode Code indicating whether another immunosuppressant was used for GVHD (Graft Versus Host Disease) prophylaxis. Code indicating whether another immunosuppressant was used for GVHD (Graft Versus Host Disease) prophylaxis. Other immunosuppressant 1;2;1;2 Yes;No;Yes;No Numeric Values

If given or discontinued during assessment period, specify all immunosuppressants used for GVHD prophylaxis

Adult;Pediatric Proposed 1.00 2018-12-14 11:06:16.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPROTHR
C58881 Alkaline phosphatase high measurement AlklinPhosphatasHighMeasr Highest measurement of alkaline phosphatase. Highest measurement of alkaline phosphatase. Highest alkaline phosphatase value Numeric Values

Record the highest value during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-17 10:51:09.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

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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/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHCHPH
C58860 Diarrhea nausea vomit liver function abnormal present time diagnosis indicate code DiaNauVomLivFnAbnPrTmDxIndCod Code indicating whether any of the following were present at the time of diagnosis: diarrhea, nausea, vomiting, liver function abnormalities. Code indicating whether any of the following were present at the time of diagnosis: diarrhea, nausea, vomiting, liver function abnormalities. Was diarrhea, nausea, vomiting or liver function abnormalities present at the time of diagnosis? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 12:35:39.0 Follow Up/Chronic GVHD Form Treatment/Intervention Data Transplantation/Stem Cell Transplant

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 Treatment/Intervention Data Transplantation/Stem Cell Transplant

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGBIO1TY
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