Sub-Domain: Participant History and Family History
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59112 | Infection grade | InfectionGrade | Grade of infection exhibited by the patient. | Grade of infection exhibited by the patient. | Infection | 0;3;4;5 | Grades 0–2;IV antibiotic, antifungal, or antiviral indicated, radiologic, operative intervention indicated;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Proposed | 1.00 | 2019-01-16 11:59:41.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFECTIN | ||||||||||||||||||||||||||
| C59078 | Pain right upper quadrant indicate code | PnRtUpQuadIndCode | Code indicating whether pain in the right upper quadrant indicative of abnormal liver function is exhibited by the patient. | Code indicating whether pain in the right upper quadrant indicative of abnormal liver function is exhibited by the patient. | Right upper quadrant pain | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate all clinical signs/symptoms of abnormal liver functioning present during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2019-01-11 14:24:51.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | RTQUADPN | ||||||||||||||||||||||||||
| C59123 | Hair thinning indicate code | HairThinningIndCode | Code indicating whether the patient has thinning hair | Code indicating whether the patient has thinning hair | Does the patient have thinning hair? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-17 07:21:13.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | THINHAIR | |||||||||||||||||||||||||||
| C58972 | Etiology liver abnormality infection indicate code | EtiolLivrAbnrmInfctnIndCode | Code indicating whether the etiology of the liver abnormality was determined to be an infection. | Code indicating whether the etiology of the liver abnormality was determined to be an infection. | Etiology: infection | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate the etiology of the abnormal liver function |
Adult;Pediatric | Proposed | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | LIVETINF | ||||||||||||||||||||||||||
| C59102 | Fever grade | FeverGrade | Grade of fever exhibited by the patient | Grade of fever exhibited by the patient | Fever | 0;3;4;5 | Grades 0–2;>40.0 degrees C (>104.0 degrees F) for <= 24 hours;>40.0 degrees C (>104.0 degrees F) for > 24 hours;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Proposed | 1.00 | 2019-01-15 14:30:15.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXFEVER | ||||||||||||||||||||||||||
| C59056 | Hemorrhage grade | HemorrhageGrade | Grade of hemorrhage | Grade of hemorrhage | Hemorrhage | 0;3;4;5 | Grades 0–2;Transfusion, radiologic, endoscopic, or elective operative intervention indicated;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Proposed | 1.00 | 2019-01-11 10:20:17.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEMORRHG | ||||||||||||||||||||||||||
| C59067 | Dyspnea grade | DyspneaGrade | Grade of dyspnea exhibited by the patient. | Grade of dyspnea exhibited by the patient. | Dyspnea | 0;3;4;5 | Grades 0–2;Shortness of breath at rest, limiting self care ADL;Life-threatening consequences, urgent intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Proposed | 1.00 | 2019-01-11 11:28:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXDYSPNA | ||||||||||||||||||||||||||
| C59113 | Iron overload grade | IronOverloadGrade | Grade of iron overload exhibited by the patient. | Grade of iron overload exhibited by the patient. | Iron overload | 0;3;4;5 | Grades 0–2;Severe symptoms, intervention indicated;Life-threatening, urgent radiologic or operative intervention indicated;Death | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Proposed | 1.00 | 2019-01-16 12:03:06.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | IRONOVER | ||||||||||||||||||||||||||
| C59079 | Weight gain greater 5 percent over baseline indicate code | WtGnGrtr5PctOvrBaslinIndCode | Code indicating whether weight gain greater than 5 percent above baseline is exhibited by the patient. | Code indicating whether weight gain greater than 5 percent above baseline is exhibited by the patient. | Weight gain (>5%) from baseline | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate all clinical signs/symptoms of abnormal liver functioning present during this assessment period |
Adult;Pediatric | Proposed | 1.00 | 2019-01-11 14:28:31.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXWGHTGN | ||||||||||||||||||||||||||
| C59124 | Oligospermia grade | OligospermiaGrade | Grade of oligospermia (reduced sperm) | Grade of oligospermia (reduced sperm) | Oligospermia (reduced sperm) | 0;3 | Grades 0–2;Sperm concentration <13 million/mL or motility <32% | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Proposed | 1.00 | 2019-01-17 07:23:04.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | OLGSPERM | ||||||||||||||||||||||||||
| C58973 | Etiology liver abnormality veno-occlusive disease indicate code | EtiolLivrAbnrmVODIndCode | Code indicating whether the etiology of the liver abnormality was determined to be VOD (veno-occlusive disease). | Code indicating whether the etiology of the liver abnormality was determined to be VOD (veno-occlusive disease). | Etiology: VOD | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate the etiology of the abnormal liver function |
Adult;Pediatric | Proposed | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | LIVETVOD | ||||||||||||||||||||||||||
| C59103 | Maculo-papular rash grade | MaculoPapularRashGrade | Grade of the patient's maculo-papular rash | Grade of the patient's maculo-papular rash | Maculo-papular rash | 0;3 | Grades 0–2;Macules/papules covering >30% body surface area with our without associated symptoms, limiting self-care ADL | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Proposed | 1.00 | 2019-01-15 14:38:17.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | MAPARASH | ||||||||||||||||||||||||||
| C59057 | Hemorrhage organ system code | HemorrhagOrgnSystmCode | Code denoting the organ system with which hemorrhage was associated | Code denoting the organ system with which hemorrhage was associated | Which organ system was the hemorrhage associated with? | 1;2;3;4;5 | Central nervous system;Gastrointestinal;Genitourinary;Pulmonary, upper respiratory;Other | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 10:27:10.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ORGSYHEM | |||||||||||||||||||||||||||
| C59068 | Idiopathic pneumonia syndrome indicate code | IPSIndCode | Code indicating whether the patient experienced idiopathic pneumonia syndrome (IPS). | Code indicating whether the patient experienced idiopathic pneumonia syndrome (IPS). | Did the patient experience idiopathic pneumonia syndrome (IPS)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 11:32:52.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXXIPS | |||||||||||||||||||||||||||
| C59114 | Allo-antibody indicate code | AlloAntibodyIndCode | Code indicating whether the patient exhibited allo-antibodies. | Code indicating whether the patient exhibited allo-antibodies. | Did the patient develop allo-antibodies? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-16 12:35:26.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ALLOANTB | |||||||||||||||||||||||||||
| C59093 | Liver biopsy VOD result code | LivrBiopsyVODResultCode | Code for the result of the liver biopsy performed for hepatic veno-occlusive disease (VOD). | Code for the result of the liver biopsy performed for hepatic veno-occlusive disease (VOD). | VOD: biopsy results | 1;2;3;4 | Positive;Negative;Equivocal;Not done | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | VODBIOP | |||||||||||||||||||||||||||
| C58974 | Etiology liver abnormality other indicate code | EtiolLivrAbnrmOthrIndCode | Code indicating whether the etiology of the liver abnormality was determined to be Other. | Code indicating whether the etiology of the liver abnormality was determined to be Other. | Etiology: other | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate the etiology of the abnormal liver function |
Adult;Pediatric | Proposed | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | LIVETOTH | ||||||||||||||||||||||||||
| C59104 | Urticaria grade | UrticariaGrade | Grade of the patient's urticaria | Grade of the patient's urticaria | Urticaria | 0;3 | Grades 0–2;Urticarial lesions covering >30% body surface area, IV intervention indicated | Numeric Values |
Record the highest grade of toxicity diagnosed since the previous evaluation. If this is the first evaluation, record the highest toxicity diagnosed since Day 0. The toxicity grades are based on the NCI CTCAE Version 4.02. |
Adult;Pediatric | Proposed | 1.00 | 2019-01-15 14:41:05.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | URTICARI | ||||||||||||||||||||||||||
| C59058 | Hemorrhage organ system code other text | HemorrhagOrgnSystmCodeOTH | The free-text field related to 'Hemorrhage organ system code' specifying other text. | The free-text field related to 'Hemorrhage organ system code' specifying other text. | Specify other organ system | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 10:38:04.0 | Toxicity Form | Participant History and Family History | General Health History | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ORGSYHSP | ||||||||||||||||||||||||||||
| C59069 | Pneumonia radiographic evidence infection no evidence indicate code | PneumRadEvInfctnNoEvIndCode | Code indicating whether there is radiographic evidence of pnemonia without evidence of infection. | Code indicating whether there is radiographic evidence of pnemonia without evidence of infection. | Did the patient have radiographic evidence of bilateral, multi-lobar infiltrates by chest x-ray or CT scan without evidence of an infection? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 13:17:56.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXXRADEV | |||||||||||||||||||||||||||
| C59115 | Hydroxyurea receive indicate code | HydroxyureaRcvIndCode | Code indicating whether the patient received hydroxyurea. | Code indicating whether the patient received hydroxyurea. | Did the patient receive Hydroxyurea during this reporting period? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-16 12:48:41.0 | Toxicity Form | Participant History and Family History | General Health History |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HUREC |
