Sub-Domain: Safety Data
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59097 | Liver abnormality VOD doppler ultrasound result code | LvrAbnmtyVODDplrUltrsdRsltCode | Code denoting whether doppler ultrasound results confirmed a hepatic vaso-occlusive disease (VOD) etiology for abnormal liver function | Code denoting whether doppler ultrasound results confirmed a hepatic vaso-occlusive disease (VOD) etiology for abnormal liver function | VOD: doppler ultrasound results | 1;2;3 | Confirmed;Not confirmed;Not done | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2019-01-15 13:39:46.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | VODDOPP | |||||||||||||||||||||||||||
| C59041 | Cystitis noninfective toxicity grade | CystitsNoninfectToxicityGrade | Grade of noninfective cystitis toxicity exhibited by the patient. | Grade of noninfective cystitis toxicity exhibited by the patient. | Cystitis noninfective | 0;3;4;5 | Grades 0–2;Gross hematuria, transfusion, IV meds or hosp indicated;Life-threatening consequences, 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 | Supplemental | 1.00 | 2019-01-10 12:34:44.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CYSTNINF | ||||||||||||||||||||||||||
| C59108 | Hypoxia over 24 hour grade | HypoxiaOver24HrGrade | Grade of hypoxia exhibited by the patient for over 24 hours | Grade of hypoxia exhibited by the patient for over 24 hours | Hypoxia (for more than 24 hours) | 0;3;4;5 | Grades 0–2;Decreased oxygen saturation at rest (e.g. pulse oximeter <88% or PaO2 <= 55 mmHg);Life-threatening airway 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 | Supplemental | 1.00 | 2019-01-16 10:31:42.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXHYPXIA | ||||||||||||||||||||||||||
| C59062 | Somnolence grade | SomnolenceGrade | Grade of somnolence exhibited by the patient | Grade of somnolence exhibited by the patient | Somnolence | 0;3;4;5 | Grades 0–2;Obtundation or stupor;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 | Supplemental | 1.00 | 2019-01-11 10:56:04.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | SOMNOLN | ||||||||||||||||||||||||||
| C59073 | Aspartate aminotransferase toxicity grade | ASTToxicityGrade | Grade of aspartate aminotransferase (AST) toxicity exhibited by the patient. | Grade of aspartate aminotransferase (AST) toxicity exhibited by the patient. | AST | 0;3;4 | Grades 0–2;>5.0–20.0 times upper limit of normal;>20.0 times upper limit of normal | 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 | Supplemental | 1.00 | 2019-01-11 13:51:29.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXAST | ||||||||||||||||||||||||||
| C59119 | Nausea grade | NauseaGrade | Grade of nausea exhibited by the patient | Grade of nausea exhibited by the patient | Nausea | 0;3 | Grades 0–2;Inadequate oral caloric or fluid intake, tube feeding, TPN, or hospitalization 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 | Supplemental | 1.00 | 2019-01-16 13:53:51.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXNAUSEA | ||||||||||||||||||||||||||
| 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 | Supplemental | 3.00 | 2013-07-16 14:01:43.01 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr | 4000 |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C59098 | Liver abnormality GVHD doppler ultrasound result code | LvrAbnmtyGVHDDplrUltrsdRstCode | Code denoting whether doppler ultrasound results confirmed a graft-versus-host disease (GVHD) etiology for abnormal liver function | Code denoting whether doppler ultrasound results confirmed a graft-versus-host disease (GVHD) etiology for abnormal liver function | GVHD: doppler ultrasound results | 1;2;3 | Confirmed;Not confirmed;Not done | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2019-01-15 13:39:46.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | GVHDDOPP | |||||||||||||||||||||||||||
| C59042 | Acute kidney injury toxicity grade | AcuteKidnyInjryToxicityGrade | Grade of acute kidney injury toxicity exhibited by the patient. | Grade of acute kidney injury toxicity exhibited by the patient. | Acute kidney injury | 0;3;4;5 | Grades 0–2;Creatinine >3x baseline, >4.0 mg/dL, hospitalization indicated;Life-threatening consequences, dialysis 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 | Supplemental | 1.00 | 2019-01-10 12:40:48.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ACKIDINJ | ||||||||||||||||||||||||||
| C59109 | Anaphylaxis grade | AnaphylaxisGrade | Grade of anaphylaxis exhibited by the patient. | Grade of anaphylaxis exhibited by the patient. | Anaphylaxis | 0;3;4;5 | No event;Symptomatic bronchospasm, parenteral intervention indicated, allergy-related edema/angioderma;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 | Supplemental | 1.00 | 2019-01-16 11:49:21.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ANAPHYLX | ||||||||||||||||||||||||||
| C59063 | Reversible posterior leukoencephalopathy syndrome grade | RevPostLeukonencephSyndrGrade | Grade of reversible posterior leukoencephalopathy syndrome (PRES) exhibited by the patient. | Grade of reversible posterior leukoencephalopathy syndrome (PRES) exhibited by the patient. | Reversible posterior leukoencephalopathy syndrome | 0;3;4;5 | Grades 0–2;Severe symptoms, very abnormal imaging studies, 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 | Supplemental | 1.00 | 2019-01-11 10:59:03.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXXPRES | ||||||||||||||||||||||||||
| C59074 | Bilirubin toxicity grade | BilirubinToxicityGrade | Grade of bilirubin toxicity exhibited by the patient. | Grade of bilirubin toxicity exhibited by the patient. | Bilirubin | 0;3;4 | Grades 0–2;>3.0–10.0 times upper limit of normal;>10.0 times upper limit of normal | 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 | Supplemental | 1.00 | 2019-01-11 13:51:29.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXBILIRB | ||||||||||||||||||||||||||
| C59120 | Diarrhea grade | DiarrheaGrade | Grade of diarrhea exhibited by the patient. | Grade of diarrhea exhibited by the patient. | Diarrhea | 0;3;4;5 | Grades 0–2;Increase of >= 7 stools per day, incontinence, severe increase in ostomy, limiting self care activities of daily living;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 | Supplemental | 1.00 | 2019-01-16 13:56:46.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | DIARRHEA | ||||||||||||||||||||||||||
| C19500 | Assessment performed date | AssessmentPerformedDate | The date of assessment of the examination being performed. | The date of assessment of the examination being performed. | Record date of evaluation | Date or Date & Time | Adult;Pediatric | Supplemental | 1.00 | 2014-06-18 08:10:12.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Free-Form Entry |
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| C59099 | Liver abnormality infection doppler ultrasound result code | LvrAbnmtyInfDplrUltrsdRstCode | Code denoting whether doppler ultrasound results confirmed an infection etiology for abnormal liver function | Code denoting whether doppler ultrasound results confirmed an infection etiology for abnormal liver function | Infection: doppler ultrasound results | 1;2;3 | Confirmed;Not confirmed;Not done | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2019-01-15 13:39:46.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFDOPP | |||||||||||||||||||||||||||
| C59043 | Chronic kidney disease toxicity grade | ChronKidnyDzToxicityGrade | Grade of chronic kidney disease toxicity exhibited by the patient. | Grade of chronic kidney disease toxicity exhibited by the patient. | Chronic kidney disease | 0;3;4;5 | Grades 0–2;eGFR or CrCI 29-15 mL/min/1.73m^2;eGFR <15 mL/min/1.73 m^2, dialysis or renal transplant 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 | Supplemental | 1.00 | 2019-01-10 12:45:24.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CHKIDDIS | ||||||||||||||||||||||||||
| C59110 | Hematuria grade | HematuriaGrade | Grade of hematuria exhibited by the patient. | Grade of hematuria exhibited by the patient. | Hematuria | 3;0;4;5 | Gross hematuria, transfusion, IV med, hosp., endoscopic, radiologic/operative inervention indicated;Grades 0–2;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 | Supplemental | 1.00 | 2019-01-16 11:52:34.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEMATURI | ||||||||||||||||||||||||||
| C59064 | Thrombotic thrombocytopenic purpura grade | ThrmbotcThrmbocytopencPrpGrade | Grade of thrombotic thrombocytopenic purpura exhibited by the patient. | Grade of thrombotic thrombocytopenic purpura exhibited by the patient. | Thrombotic thrombocytopenic purpura | 0;3;4;5 | Grades 0–2;Laboratory findings with clinical consequences [e.g., renal insufficiency, petechiae];Life-threatening consequences [e.g., CNS hemorrhage or thrombosis/embolism or renal failure];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 | Supplemental | 1.00 | 2019-01-11 11:04:12.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | THRMBPUR | ||||||||||||||||||||||||||
| C59075 | Alkaline phosphatase toxicity grade | AlkPhosphToxicityGrade | Grade of alkaline phosphatase toxicity exhibited by the patient. | Grade of alkaline phosphatase toxicity exhibited by the patient. | Alkaline phosphatase | 0;3;4 | Grades 0–2;>5.0–20.0 times upper limit of normal;>20.0 times upper limit of normal | 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 | Supplemental | 1.00 | 2019-01-11 13:51:29.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXALKPH | ||||||||||||||||||||||||||
| C59121 | Constipation grade | ConstipationGrade | Grade of constipation exhibited by the patient | Grade of constipation exhibited by the patient | Constipation | 0;3;4;5 | Grades 0–2;Obstipation with manual evacuation indicated, limiting self care activities of daily living;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 | Supplemental | 1.00 | 2019-01-17 07:16:45.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CONSTIPA | ||||||||||||||||||||||||||
| C58064 | Skin jaundice assessment status | SkinJaundiceAssmtStat | The status of skin jaundice assessment in physical examination. | The status of skin jaundice assessment in physical examination. | Jaundice | 1;2 | Yes;No | Alphanumeric |
Indicate all clinical signs/symptoms of abnormal liver functioning present during this assessment period |
Adult;Pediatric | Supplemental | 1.00 | 2018-01-23 12:29:34.0 | Toxicity Form | Safety Data | general-data-protection-regulation-gdpr |
Single Pre-Defined Value Selected |
