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

Displaying 1 - 50 of 96
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type Source Form Set Form Field
C58884 Joint contracture status code JointContractureStatusCode Code denoting the status of the subject/participant's joint contractures Code denoting the status of the subject/participant's joint contractures Contractures 0;1;2;3 No symptoms/undefined;Mild joint contractures;Moderate joint contractures;Severe joint contractures Numeric Values

Indicate the maximum severity of involvment during this assessment period

Adult;Pediatric Proposed 1.00 2018-12-17 11:04:49.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGCONTRC
C58918 In vivo immunotoxin therapy chronic GVHD indicate code IVImntxnThpyChrnGVHDIndCode Code indicating whether in vivo immunotoxin therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether in vivo immunotoxin therapy was used to treat chronic GVHD (graft-versus-host disease) In Vivo Immunotoxin 1;2;1;2 Yes;No;Yes;No Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHIMM
C58852 Chronic GVHD severity maximum code ChronGVHDSevertyMaxCode Code denoting the maximum severity of the subject/participant's chronic GVHD (Graft Versus Host Disease) Code denoting the maximum severity of the subject/participant's chronic GVHD (Graft Versus Host Disease) Maximum overall severity of chronic GVHD during this
assessment period
0;1;2;3 No chronic GVHD;Mild;Moderate;Severe Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 11:34:03.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGSVCGVH
C58863 Rash maculopapular present indicate code RashMaculopaplrPresentIndCode Code indicating whether maculopapular skin rash is present Code indicating whether maculopapular skin rash is present Maculopapular 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 12:47:02.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGRSMACU
C58895 Biopsy suspect GVHD result code BiopsySuspectGVHDResltCode Code denoting the result of the biopsy performed for suspected GVHD (Graft Versus Host Disease) Code denoting the result of the biopsy performed for suspected GVHD (Graft Versus Host Disease) Result of biopsy performed for suspected GVHD 1;2;3 Positive GVHD;Negative GVHD;Equivocal Numeric Values Adult;Pediatric Proposed 1.00 2018-12-17 11:49:53.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGBIO1RS
C58826 Acute GVHD sign symptom new develop indicate code AcutGVHDSgnSymNwDvlpIndCode Code indicating whether new signs or symptoms of acute GVHD (Graft Versus Host Disease) have developed. Code indicating whether new signs or symptoms of acute GVHD (Graft Versus Host Disease) have developed. Did new clinical signs and/or symptoms of acute GVHD develop during this assessment period? 1;2;1;2 Yes;No;Yes;No Numeric Values

Only report new clinical signs and/or symptoms of acute GVHD that developed during the assessment period

Adult;Pediatric Proposed 1.00 2018-12-12 15:15:50.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGAGVDVL
C58874 Esophagus GVHD status code EsophagusGVHDStatusCode Code denoting the status of the subject/participant's esophagus when suffering from GVHD (Graft Versus Host Disease). Code denoting the status of the subject/participant's esophagus when suffering from GVHD (Graft Versus Host Disease). Esophagus 0;1 No symptoms;Symptoms, confirmed with diagnostic procedure Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 14:31:57.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGESOPH
C58906 PUVA therapy chronic GVHD indicate code PUVAThpyChrnGVHDIndCode Code indicating whether PUVA (Psoralen and ultraviolet A) therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether PUVA (Psoralen and ultraviolet A) therapy was used to treat chronic GVHD (graft-versus-host disease) PUVA (Psoralen and UVA) 1;2;1;2 Yes;No;Yes;No Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHPUVA
C58842 Cyclosporine use GVHD prophylaxis indicate code CylUseGVHDProphylaxisIndCode Code indicating whether Cyclosporine was used for GVHD (Graft Versus Host Disease) prophylaxis. Code indicating whether Cyclosporine was used for GVHD (Graft Versus Host Disease) prophylaxis. Cyclosporine 1;2;1;2 Yes;No;Yes;No Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-14 11:06:16.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGPRCYCL
C58885 Myositis present indicate code MyositisPresntIndicatCode Code indicating whether myositis is present in the subject/participant Code indicating whether myositis is present in the subject/participant Myositis 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-17 11:08:02.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGMYOSIT
C58920 In vivo immunotoxin use specify text InVvoImmuntoxnUseSpcfyTxt The free-text related to 'In vivo immunotoxin therapy chronic GVHD indicate code' for specifying the in vivo immunotoxin that was used to treat chronic GVHD (graft-versus-host disease) The free-text related to 'In vivo immunotoxin therapy chronic GVHD indicate code' for specifying the in vivo immunotoxin that was used to treat chronic GVHD (graft-versus-host disease) Specify in vivo immunotoxin used to treat chronic GVHD Alphanumeric Adult;Pediatric Proposed 1.00 2018-12-17 15:38:57.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event 100

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHIMSP
C58853 Chronic GVHD sign symptom new develop indicate code ChronGVHDSgnSympNwDevIndCode Code indicating whether new signs or symptoms of chronic GVHD (Graft Versus Host Disease) have developed Code indicating whether new signs or symptoms of chronic GVHD (Graft Versus Host Disease) have developed Did new clinical signs and/or symptoms of chronic GVHD
develop during this assessment period?
1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 11:43:07.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGCGVDVL
C58864 Rash sclerodermatous present indicate code RashSclrodrmatusPresentIndCode Code indicating whether sclerodermatous skin rash is present Code indicating whether sclerodermatous skin rash is present Sclerodermatous 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 12:47:02.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGRSMACU
C58896 Therapy treat chronic GVHD indicate code TherpyTretChronGVHDIndicatCode Code indicating whether a specific therapy was used to treat chronic GVHD (Graft Versus Host Disease) Code indicating whether a specific therapy was used to treat chronic GVHD (Graft Versus Host Disease) Was a specific therapy used to treat chronic GVHD during this assessment period? 1;2;3 Yes, initiated this assessment period;Yes, continuing from previous assessment period;No Numeric Values

Therapies used for GVHD prophylaxis should not be recorded here. Only report therapies that were initiated during this assessment period. Treatment is defined as increasing the dose of an ongoing agent or addition of a new agent. Adjusting a drug taper does not qualify as treatment.

Adult;Pediatric Proposed 1.00 2018-12-17 11:55:43.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

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

Free-Form Entry

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

Indicate the maximum severity of involvment during this assessment period

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGNAUSVM
C58907 ECP therapy chronic GVHD indicate code ECPThpyChrnGVHDIndCode Code indicating whether ECP (Extra-corporeal photopheresis) therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether ECP (Extra-corporeal photopheresis) therapy was used to treat chronic GVHD (graft-versus-host disease) ECP (Extra-corporeal Photopheresis) 1;2;1;2 Yes;No;Yes;No Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGTHECP
C58843 MMF use GVHD prophylaxis indicate code MMFUseGVHDProphylaxisIndCode Code indicating whether MMF was used for GVHD (Graft Versus Host Disease) prophylaxis. Code indicating whether MMF was used for GVHD (Graft Versus Host Disease) prophylaxis. MMF 1;2;1;2 Yes;No;Yes;No Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-14 11:06:16.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGEOSINP
C58921 Other agent therapy chronic GVHD indicate code OthAgntThpyChrnGVHDIndCode Code indicating whether therapy using another agent was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether therapy using another agent was used to treat chronic GVHD (graft-versus-host disease) Was another agent used to treat chronic GVHD? 1;2;1;2 Yes;No;Yes;No Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

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

Only initial diagnosis or onset of chronic GVHD should be reported

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

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGCGDGDT
C58865 Rash other type present indicate code RashOthrTypPresentIndCode Code indicating whether another type of skin rash is present Code indicating whether another type of skin rash is present Other type of rash 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-14 12:47:02.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

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

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

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

Free-Form Entry

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

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

Adult;Pediatric Proposed 1.00 2018-12-12 15:24:41.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

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

Indicate the maximum severity of involvment during this assessment period

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDIARH
C58908 Sirolimus therapy chronic GVHD indicate code SirolimusThpyChrnGVHDIndCode Code indicating whether Sirolimus (Rapamycin) therapy was used to treat chronic GVHD (graft-versus-host disease) Code indicating whether Sirolimus (Rapamycin) therapy was used to treat chronic GVHD (graft-versus-host disease) Sirolimus (Rapamycin) 1;2;1;2 Yes;No;Yes;No Numeric Values

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

Adult;Pediatric Proposed 1.00 2018-12-17 12:03:21.0 Follow Up/Chronic GVHD Form Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

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

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 History of Disease Event

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 History of Disease Event 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 History of Disease Event

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 History of Disease Event 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 History of Disease Event

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 History of Disease Event

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 History of Disease Event

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 History of Disease Event

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 History of Disease Event

Single Pre-Defined Value Selected

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

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 Disease Related Events History of Disease Event

Free-Form Entry

0 500 kilogram DeBaun Forms
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 Disease Related Events History of Disease Event

Free-Form Entry

0 999999 cubic millimeter BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDGPLT
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

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

Single Pre-Defined Value Selected

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

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

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

Free-Form Entry

0 9999 unit per liter BMTCTN 1507A Release 5.10 Follow Up/Chronic GVHD Form (FGV) FGDGALKP
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 Disease Related Events History of Disease Event

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 Disease Related Events History of Disease Event

Single Pre-Defined Value Selected

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