Sub-Domain: Disease Related Events
CRF:
CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (Question Text) | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
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C59080 | Chronic GVHD severity 2 scale | ChrncGVHDSev2Scl | Scale indicating the level of chronic graft-versus-host disease (GVHD) from zero to ten. | Scale indicating the level of chronic graft-versus-host disease (GVHD) from zero to ten. | Please rate the severity of this person's chronic GVHD on this scale | 0;1;2;3;4;5;6;7;8;9;10 | cGVHD symptoms are not at all severe;1;2;3;4;5;6;7;8;9;cGVHD symptoms are most severe possible | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 14:59:55.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGSEV2 | |||||||||||||||||||||||||||
C59046 | Liver Function Test sample obtained date | LFTSmplObtdDate | Date when the liver function test sample was obtained | Date when the liver function test sample was obtained | Date LFT sample obtained: | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2019-01-10 13:07:16.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGLFTDT | |||||||||||||||||||||||||||||
C59092 | GYN exam not performed indicate code | GYNExNtPerfmdIndictCode | Code indicating GYN was not performed. | Code indicating GYN was not performed. | Was a GYN performed | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-14 16:44:10.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | n/a | |||||||||||||||||||||||||||
C17409 | Visit date | VisitDate | Date of interview or visit (actually the date when data in the form were captured) | Date of interview or visit | Date of visit: | Date or Date & Time | Adult;Pediatric | Proposed | 3.00 | 2013-06-21 00:00:00.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Free-Form Entry |
DeBaun Forms | LB | VISDAT |
Visit Date |
Visit Date |
What [is/was] the date of the visit? |
N/A | Char | Record the [date/start date] of the visit using DD-MON-YYYY format. | Prompt | |||||||||||||||||||||||
C59047 | Forced expiratory volume 1 second value | ForcedExpVol1SecVal | Value of %FEV1 from within one month of the assessment | Value of %FEV1 from within one month of the assessment | % FEV1 | Numeric Values |
PFT values from within one month of the assessment |
Adult;Pediatric | Proposed | 1.00 | 2019-01-10 13:18:21.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Free-Form Entry |
0 | 999 | BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGFEV1 | ||||||||||||||||||||||||||
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 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy | 4000 |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||
C59048 | Forced expiratory volume 1 second date | FrcdExpVol1SecDate | Date of FEV1 from within one month of the assessment | Date of FEV1 from within one month of the assessment | Date of FEV1 | Date or Date & Time |
PFT values from within one month of the assessment |
Adult;Pediatric | Proposed | 1.00 | 2019-01-10 13:25:26.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGFEVDT | ||||||||||||||||||||||||||||
C59031 | Skin symptom score | SkinSymptomScore | Score indicating the amount of disease signs based on skin. | Score indicating the amount of disease signs based on skin. | Skin score | 0;1;2;3 | No symptoms;<18% BSA with disease signs but NO sclerotic features;19-50% BSA OR involvement with superficial sclerotic features not hidebound (able to pinch);>50% BSA OR deep sclerotic feats. hidebound OR impaired mobility, ulceration or severe pruritis | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-09 09:27:17.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGSKIN | |||||||||||||||||||||||||||
C59049 | Forced expiratory volume 1 second not done code | FrcdExpVol1SecNtDnCode | Code indicating whether FEV was done within one month of assessment. | Code indicating whether FEV was done within one month of assessment. | FEV not done | Not done | Not done | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-10 13:37:15.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGFEVND | |||||||||||||||||||||||||||
C59032 | Mouth symptom score | MouthSymptomScore | Score indicating the level of mouth symptom related to chronic GVHD. | Score indicating the level of mouth symptom related to chronic GVHD. | Mouth Score | 0;1;2;3 | No symptoms;Mild symptoms with disease signs but not limiting oral intake significantly;Moderate symptoms with signs with partial limitation of oral intake;Severe symptoms with disease signs on examination with major limitation of oral intake | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-09 12:38:08.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGMOUTH | |||||||||||||||||||||||||||
C59050 | Diffusing capacity of the lung for carbon monoxide Value | DLOcVal | Value of % DLCOc from within one month of the assessment | Value of % DLCOc from within one month of the assessment | % DLCOc | Numeric Values |
PFT values from within one month of the assessment |
Adult;Pediatric | Proposed | 1.00 | 2019-01-10 13:48:36.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Free-Form Entry |
0 | 999 | BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGDLCO | ||||||||||||||||||||||||||
C59034 | GI tract score | GITractScore | Score used to determine GI tract symptoms related to chronic GVHD | Score used to determine GI tract symptoms related to chronic GVHD | GI Tract Score | 0;1;2;3 | No symptoms;Symptoms: dysphagia, anorexia, nausea, vomiting, abdominal pain or diarrhea with weight loss (<5%);Symptoms associated with mild to moderate weight loss (5-15%);Symptoms with significant weight loss >15%, requires nutritional supplements OR esophageal dilation | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-09 12:47:43.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGGITRC | |||||||||||||||||||||||||||
C59051 | Diffusing capacity of the lung for carbon monoxide Date | DLCOcDate | Date of diffusing capacity of the lung for carbon monoxide | Date of diffusing capacity of the lung for carbon monoxide | Date of DLCOc | Date or Date & Time |
PFT values from within one month of the assessment |
Adult;Pediatric | Proposed | 1.00 | 2019-01-10 13:53:00.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGDLCDT | ||||||||||||||||||||||||||||
C59036 | Eye symptom score | EyeSymptmScore | Score indicating the severity of eye symptom as it relates to chronic GVHD. | Score indicating the severity of eye symptom as it relates to chronic GVHD. | Eye score | 0;1;2;3 | No symptoms;Mild dry eye not affecting ADL OR asymptomatic signs of kerato-conjunctivitis sicca;Moderate dry eye partially affecting ADL WITHOUT vision impairment;Severe dry eye symptoms significantly affecting ADL OR unable to work OR loss of vision | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-09 14:28:06.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGEYE | |||||||||||||||||||||||||||
C59052 | DLCOc not done code | DLCOcNtDnCode | Code indicating whether diffusing capacity of the lung adjusted for hemoglobin (DLCOc) was completed from within one month of the assessment | Code indicating whether diffusing capacity of the lung adjusted for hemoglobin (DLCOc) was completed from within one month of the assessment | DLCOc value not done | Not done | Not done | Alphanumeric |
PFT values from within one month of the assessment |
Adult;Pediatric | Proposed | 1.00 | 2019-01-10 13:56:34.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGDLCND | ||||||||||||||||||||||||||
C59037 | Joint and Fascia Symptom Score | JointAndFasciaSymtmScore | Score indicating the severity of joint and fascia symptoms as it relates to chronic GVHD. | Score indicating the severity of joint and fascia symptoms as it relates to chronic GVHD. | Joint and Fascia Score | 0;1;2;3 | No symptoms;Mild tightness of arms or legs, normal or mild decreased range of motion (ROM) AND not affecting ADL;Tightness of arms or legs OR joint contractures, erythema due to fasciitis, moderate decrease in ROM;Contracture WITH significant decrease of ROM AND significant limitation of ADL | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-09 14:34:50.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PGCJOINT | |||||||||||||||||||||||||||
C59053 | Rash type present code | RashTypPrsntCode | Code indicating if an erythematous or maculopapular rash is present | Code indicating if an erythematous or maculopapular rash is present | Is an erythematous or maculopapular rash present? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-10 14:04:20.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGRASH | |||||||||||||||||||||||||||
C59038 | Genital tract symptom score | GntlTrctSymptmScore | Score indicating the severity of genital tract symptom(s) as it relates to chronic GVHD | Score indicating the severity of genital tract symptom(s) as it relates to chronic GVHD | Genital Tract Score | 0;1;2;3 | No symptoms;Symptomatic, mild distinct signs on exam and no effect on coitus, minimal discomfort with GYN exam;Symptomatic, distinct signs on exam and mild dyspareunia or discomfort with GYN exam;Symptomatic, advanced signs, severe pain with coitus or inability to insert vaginal spectrum | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-10 11:16:25.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGGNITL | |||||||||||||||||||||||||||
C59054 | Nausea vomiting diarrhea present code | NsaVomDrhaPrsntCode | Code indicating whether patient is presently experiencing nausea, vomiting, or diarrhea. | Code indicating whether patient is presently experiencing nausea, vomiting, or diarrhea. | Does the patient have nausea, vomiting or diarrhea? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-10 14:09:36.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGVOMIT | |||||||||||||||||||||||||||
C59039 | Lung symptom score | LungSymptomScore | Score indicating the severity of lung symptom as it relates to chronic GVHD | Score indicating the severity of lung symptom as it relates to chronic GVHD | Lung Score | 0;1;2;3 | No symptoms;Mild symptoms (shortness of breath after climbing one flight of steps);Moderate symptoms (shortness of breath after walking on flat ground);Severe symptoms (shortness of breath at rest requiring oxygen) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-10 11:23:20.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGLUNG | |||||||||||||||||||||||||||
C59076 | Chronic GVHD severity 1 scale | ChrncGVHDSev1Scl | Scale used to determine severity of chronic graft-versus-host disease (GVHD). | Scale used to determine severity of chronic graft-versus-host disease (GVHD). | Please rate the severity of this person's chronic GVHD on this scale | 1;2;3;4 | None;mild;Moderate;severe | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 14:04:17.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGSEV1 | |||||||||||||||||||||||||||
C59045 | Liver symptom score | LiverSymptomScore | Score indicating the severity of liver symptoms as it relates to chronic GVHD | Score indicating the severity of liver symptoms as it relates to chronic GVHD | Liver Score | 0;1;2;3 | Normal LFTs;Elevated bilirubin, alkaline phosphatase, AST or ALT <2xULN;Bilirubin >3 mg/dl or bilirubin, AST or ALT 2-5x ULN;Bilirubin, AST or ALT >5x ULN | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-10 12:53:59.0 | Chronic GVHD Provider Survey (PCG) | Disease Related Events | cookie-policy |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Chronic GVHD Provider Survey (PCG) | PCGLIVER |