Sub-Domain: Safety Data
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Supplemental | 1.00 | 2019-01-11 10:46:51.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities | 100 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CRDARRSP | ||||||||||||||||||||||||||||
| 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 | Supplemental | 1.00 | 2019-01-16 13:45:25.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | NEUPENIA | ||||||||||||||||||||||||||
| 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 | Supplemental | 1.00 | 2019-01-11 13:48:16.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ABNRESP | |||||||||||||||||||||||||||
| C59040 | Mucositis toxicity grade | MucositisToxicityGrade | Grade of mucositis toxicity exhibited by the patient. | Grade of mucositis toxicity exhibited by the patient. | Mucositis | 0;3;4;5 | Grades 0–2;Severe pain, interfering with oral intake, 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 | 2019-01-10 12:30:05.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | MUCOSITI | ||||||||||||||||||||||||||
| C59096 | Etiology liver abnormality unknown indicate code | EtiolLivrAbnrmUnkIndCode | Code indicating whether the etiology of the liver abnormality was unknown. | Code indicating whether the etiology of the liver abnormality was unknown. | Etiology: Unknown | 1;2;1;2 | Yes;No;Yes;No | Numeric Values |
Indicate the etiology of the abnormal liver function |
Adult;Pediatric | Supplemental | 1.00 | 2019-01-04 13:57:59.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | UNKETIOL | ||||||||||||||||||||||||||
| C59107 | Hypotension grade | HypotensionGrade | Grade of hypotension exhibited by the patient. | Grade of hypotension exhibited by the patient. | Hypotension | 0;3;4;5 | Grades 0–2;Medical intervention or hospitalization indicated;Life-threatening and 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 10:28:43.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HYPOTEN | ||||||||||||||||||||||||||
| C59061 | Systolic dysfunction left ventricle grade | SystolDysfuncLftVentricleGrade | Grade of left ventricular systolic dysfunction exhibited by the patient. | Grade of left ventricular systolic dysfunction exhibited by the patient. | Left ventricular systolic dysfunction | 0;3;4;5 | Grades 0–2;Symptomatic due to drop in ejection fraction responsive to intervention;Refractory or poorly controlled HF: ventricular device, iv vaso, or heart transplant is 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 10:51:15.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | LFVTSYDF | ||||||||||||||||||||||||||
| C59118 | Thrombocytopenia grade | ThrombocytopeniaGrade | Grade of thrombocytopenia (decreased platelet count) exhibited by the patient | Grade of thrombocytopenia (decreased platelet count) exhibited by the patient | Thrombocytopenia (platelet count decreased) | 0;3;4 | Grades 0–2;<50,000–25,000/mm^3, <50.0–25.0 x 10^9 /L;<25,000/mm^3, <25.0 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 | Supplemental | 1.00 | 2019-01-16 13:49:19.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | THROMBTP | ||||||||||||||||||||||||||
| C05147 | Transfusion indicator | TransfusionInd | Indicator of transfusion performed on participant/subject | Indicator of transfusion performed on participant/subject | Did the patient receive a transfusion during this reporting period? | Yes;No | Yes;No | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C59072 | Alanine aminotransferase toxicity grade | ALTToxicityGrade | Grade of alanine aminotransferase (ALT) toxicity exhibited by the patient. | Grade of alanine aminotransferase (ALT) toxicity exhibited by the patient. | ALT | 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXALT | ||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CYSTNINF | ||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | VODDOPP | |||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | SOMNOLN | ||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
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 | Adverse Events/Toxicities | 4000 |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXAST | ||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ACKIDINJ | ||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | GVHDDOPP | |||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | TXXPRES |
