Sub-Domain: Additional Proposed Instruments
CRF: Toxicity Form
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | MAPARASH | ||||||||||||||||||||||||||
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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | LIVETOTH | ||||||||||||||||||||||||||
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 | Additional Proposed Instruments | Other | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ORGSYHSP | ||||||||||||||||||||||||||||
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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | URTICARI | ||||||||||||||||||||||||||
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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HUREC | |||||||||||||||||||||||||||
C59094 | Liver biopsy infection result code | LivrBiopsyInfctnResultCode | Code for the result of the liver biopsy performed for infection. | Code for the result of the liver biopsy performed for infection. | Infection: 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFBIOP | |||||||||||||||||||||||||||
C58975 | Etiology liver abnormality other indicate code other text | EtiolLivrAbnrmOthrIndCodeOTH | The free-text field related to 'Etiology liver abnormality other indicate code' specifying other text. | The free-text field related to 'Etiology liver abnormality other indicate code' specifying other text. | Specify other etiology | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-04 14:09:08.0 | Toxicity Form | Additional Proposed Instruments | Other | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | GVHLIVRS | ||||||||||||||||||||||||||||
C59059 | Cardiac arrhythmia grade | CardiacArrhythmiaGrade | Grade of cardiac arrhythmia exhibited by the patient. | Grade of cardiac arrhythmia exhibited by the patient. | Cardiac arrhythmia | 0;3;4;5 | Grades 0–2;Severe, medically significant, medical intervention indicated;Life-threatening consequences, hemodynamic compromise, 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 10:41:25.0 | Toxicity Form | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CRDARRHY | ||||||||||||||||||||||||||
C59105 | Transfusion related allergic reaction grade | TxfusnRelateAllergReactnGrade | Grade of the patient's allergic reaction related to blood transfusion | Grade of the patient's allergic reaction related to blood transfusion | Allergic reaction | 0;3;4;5 | Grades 0–2;Prolonged, recurrence of symptoms following initial improvement, hospitalization 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 | 2019-01-15 14:23:40.0 | Toxicity Form | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ALRGCRXN | ||||||||||||||||||||||||||
C59070 | Idiopathic pneumonia syndrome date | IPSDate | Date of idiopathic pneumonia syndrome | Date of idiopathic pneumonia syndrome | Date of IPS | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 13:20:38.0 | Toxicity Form | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXXIPSDT | |||||||||||||||||||||||||||||
C59116 | Anemia grade | AnemiaGrade | Grade of anemia exhibited by the patient. | Grade of anemia exhibited by the patient. | Anemia | 0;3;4;5 | Grades 0–2;Hemoglobin <8.0–6.5 g/dL, <4.9–4.0 mmol/L, <80–65 g/L, transfusion 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 13:32:44.0 | Toxicity Form | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ANEMIA | ||||||||||||||||||||||||||
C59095 | Liver biopsy other etiology result code | LivrBiopsyOthEtResultCode | Code for the result of the liver biopsy performed for other etiology. | Code for the result of the liver biopsy performed for other etiology. | Other etiology: 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | OTHBIOP | |||||||||||||||||||||||||||
C58976 | Liver biopsy GVHD result code | LivrBiopsyGVHDResultCode | Code for the result of the liver biopsy performed for graft-versus-host disease (GVHD) | Code for the result of the liver biopsy performed for graft-versus-host disease (GVHD) | GVHD: 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Acute GVHD Form (GVH) | GVHLIVRB | |||||||||||||||||||||||||||
C59060 | Cardiac arrhythmia specify text | CardiacArrhythmiaSpcfyTxt | Text specifying the cardiac arrhythmia exhibited by the patient. | Text specifying the cardiac arrhythmia exhibited by the patient. | Specify arryhthmia | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 10:46:51.0 | Toxicity Form | Additional Proposed Instruments | Other | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CRDARRSP | ||||||||||||||||||||||||||||
C59106 | Bronchospasm grade | BronchospasmGrade | Grade of bronchospasm exhibited by the patient | Grade of bronchospasm exhibited by the patient | Bronchospasm | 0;3;4;5 | Grades 0–2;Limiting self-care activities of daily living, oxygen saturation decreased;Life-threatening respiratory or hemodynamic compromise, intubation or 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 10:23:09.0 | Toxicity Form | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | BRCHSPAM | ||||||||||||||||||||||||||
C59071 | Abnormal respiratory physiology supplemental oxygen indicate code | AbnRespPhysiolSupplO2IndCode | Code indicating whether the patient exhibited evidence of abnormal respiratory physiology or needed supplemental oxygen. | Code indicating whether the patient exhibited evidence of abnormal respiratory physiology or needed supplemental oxygen. | Did the patient have evidence for abnormal respiratory physiology based upon a room air oxygen saturation <93%, or the need for supplemental oxygen to maintain an oxygen saturation >93%? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2019-01-11 13:48:16.0 | Toxicity Form | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ABNRESP | |||||||||||||||||||||||||||
C59117 | Neutropenia grade | NeutropeniaGrade | Grade of neutropenia (decreased neutrophil count) exhibited by the patient. | Grade of neutropenia (decreased neutrophil count) exhibited by the patient. | Neutropenia (neutrophil count decreased) | 0;3;4 | Grades 0–2;<1000–500/mm^3, <1.0–0.5 x 10^9/L;<500/mm^3, <0.5 x 10^9/L | 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 13:45:25.0 | Toxicity Form | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | NEUPENIA |