CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Outcomes and End Points
CRF: Toxicity Form

Displaying 1 - 50 of 71
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
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 Outcomes and End Points Renal Function Testing/Status

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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 Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Toxicity Form (T29) ALLOANTB
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 Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Acute GVHD Form (GVH) LIVETOTH
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 Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Toxicity Form (T29) VODBIOP
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 Outcomes and End Points Renal Function Testing/Status 100

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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 Outcomes and End Points Renal Function Testing/Status

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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 Outcomes and End Points Renal Function Testing/Status

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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 Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Toxicity Form (T29) HUREC
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 Outcomes and End Points Renal Function Testing/Status 100

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BMTCTN 1507A Release 5.10 Acute GVHD Form (GVH) GVHLIVRS
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 Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Toxicity Form (T29) INFBIOP
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 Outcomes and End Points Renal Function Testing/Status

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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 Outcomes and End Points Renal Function Testing/Status

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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 Outcomes and End Points Renal Function Testing/Status

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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 Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Toxicity Form (T29) ANEMIA
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 Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Acute GVHD Form (GVH) GVHLIVRB
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 Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Toxicity Form (T29) OTHBIOP
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 Outcomes and End Points Renal Function Testing/Status 100

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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 Outcomes and End Points Renal Function Testing/Status

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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 Outcomes and End Points Renal Function Testing/Status

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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 Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-10 12:30:05.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-04 13:57:59.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-11 10:51:15.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-16 10:28:43.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-11 13:51:29.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-16 13:49:19.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 3.00 2013-07-20 10:21:25.65 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-10 12:34:44.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-15 13:39:46.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-11 10:56:04.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-16 10:31:42.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-11 13:51:29.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-16 13:53:51.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 3.00 2013-07-16 14:01:43.01 Toxicity Form Outcomes and End Points Renal Function Testing/Status 4000

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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 Proposed 1.00 2019-01-10 12:40:48.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-15 13:39:46.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-11 10:59:03.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-16 11:49:21.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-11 13:51:29.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-16 13:56:46.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2014-06-18 08:10:12.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-10 12:45:24.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-15 13:39:46.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-11 11:04:12.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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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 Proposed 1.00 2019-01-16 11:52:34.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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BMTCTN 1507A Release 5.10 Toxicity Form (T29) HEMATURI
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 Proposed 1.00 2019-01-11 13:51:29.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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 Proposed 1.00 2019-01-17 07:16:45.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

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 Proposed 1.00 2018-01-23 12:29:34.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

Single Pre-Defined Value Selected

C59044 Dialysis receive indicate code DialysisReceiveIndCode Code indicating whether the patient received dialysis Code indicating whether the patient received dialysis Did the patient receive dialysis? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2019-01-10 12:51:43.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) RCVDIALY
C59100 Liver abnormality other doppler ultrasound result code LvrAbnmtyOthDplrUltrsdRstCode Code denoting whether doppler ultrasound results confirmed an etiology of Other for abnormal liver function Code denoting whether doppler ultrasound results confirmed an etiology of Other for abnormal liver function Other etiology: doppler ultrasound result 1;2;3 Confirmed;Not confirmed;Not done Numeric Values Adult;Pediatric Proposed 1.00 2019-01-15 13:39:46.0 Toxicity Form Outcomes and End Points Renal Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) OTHDOPP
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