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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Supplemental | 1.00 | 2019-01-11 14:28:31.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-17 07:23:04.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | 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 | Acute GVHD Form (GVH) | LIVETVOD | ||||||||||||||||||||||||||
| 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 | Supplemental | 1.00 | 2019-01-11 10:27:10.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | ORGSYHEM | |||||||||||||||||||||||||||
| 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 | Supplemental | 1.00 | 2019-01-15 14:38:17.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-11 11:32:52.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-16 12:35:26.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | 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 | 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 | Supplemental | 1.00 | 2019-01-11 10:38:04.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities | 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 | Supplemental | 1.00 | 2019-01-15 14:41:05.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-11 13:17:56.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-16 12:48:41.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-04 14:09:08.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities | 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 | Supplemental | 1.00 | 2019-01-11 10:41:25.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-15 14:23:40.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-11 13:20:38.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-16 13:32:44.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2019-01-04 14:12:38.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | 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 | ||||||||||||||||||||||||||||
| 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 | Supplemental | 1.00 | 2019-01-16 10:23:09.0 | Toxicity Form | Safety Data | Adverse Events/Toxicities |
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 | 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 | |||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 |
|||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
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 | Adverse Events/Toxicities |
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 | Adverse Events/Toxicities |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | CHKIDDIS | ||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | INFDOPP | |||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | THRMBPUR | ||||||||||||||||||||||||||
| 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 | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | Toxicity Form (T29) | HEMATURI |
