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
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 Cardiac Function Testing/Status

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

Single Pre-Defined Value Selected

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 Cardiac Function Testing/Status

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

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

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

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXHYPXIA
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 Cardiac Function Testing/Status

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 Proposed 3.00 2013-07-16 14:01:43.01 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status 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 Proposed 1.00 2019-01-11 13:51:29.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

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

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

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

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXXPRES
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 Cardiac Function Testing/Status

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

Free-Form Entry

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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXBILIRB
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 Cardiac Function Testing/Status

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) INFDOPP
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 Cardiac Function Testing/Status

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) THRMBPUR
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 Cardiac 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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXALKPH
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 Cardiac 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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) OTHDOPP
C59111 Hemolysis grade HemolysisGrade Grade of hemolysis exhibited by the patient. Grade of hemolysis exhibited by the patient. Hemolysis 0;3;4;5 Grades 0–2;Transfusion or medical intervention indicated (e.g. steroids);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 11:56:34.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) HEMOLYSI
C59065 Capillary leak syndrome grade CapillryLeakSyndromeGrade Grade of capillary leak syndrome exhibited by the patient. Grade of capillary leak syndrome exhibited by the patient. Capillary leak syndrome 0;3;4;5 Grades 0–2;Severe symptoms, intervention 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 2019-01-11 11:11:23.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) CAPLKSYN
C59122 Hyperpigmentation skin under nail indicate code HyprpgmntatnSknUndNailIndCode Code indicating whether the patient has hyperpigmentation of the skin under the nails Code indicating whether the patient has hyperpigmentation of the skin under the nails Does the patient have hyperpigmentation of the skin under the nails? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2019-01-17 07:19:38.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) HYPEPIGM
C58968 Etiology liver abnormality GVHD indicate code EtiolLivrAbnormGVHDIndCode Code indicating whether the etiology of the liver abnormality was determined to be GVHD (graft-versus-host disease). Code indicating whether the etiology of the liver abnormality was determined to be GVHD (graft-versus-host disease). Etiology: GVHD 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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Acute GVHD Form (GVH) LIVETGVH
C59077 Hepatomegaly indicate code HepatomegalyIndCode Code indicating whether hepatomegaly is exhibited by the patient. Code indicating whether hepatomegaly is exhibited by the patient. Hepatomegaly 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 Proposed 1.00 2019-01-11 14:22:12.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) HEPTMGLY
C59055 Dialysis result laboratory values correct indicate code DialysRsltLabValCrctIndCode Code indicating that dialysis resulted in correct laboratory values. Code indicating that dialysis resulted in correct laboratory values. If the patient received dialysis, were the laboratory values corrected? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2019-01-11 10:16:18.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) LBVALCOR
C59101 Transfusion related reaction grade TxfusnRelateReactnGrade Grade of the patient's reaction related to blood transfusion Grade of the patient's reaction related to blood transfusion Infusion related 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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) INFRLRXN
C59112 Infection grade InfectionGrade Grade of infection exhibited by the patient. Grade of infection exhibited by the patient. Infection 0;3;4;5 Grades 0–2;IV antibiotic, antifungal, or antiviral indicated, radiologic, operative intervention 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 11:59:41.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) INFECTIN
C59066 Hypertension grade HypertensionGrade Grade of hypertension exhibited by the patient. Grade of hypertension exhibited by the patient. Hypertension 0;3;4;5 Grades 0–2;Stage 2 [systolic BP 160+ mmHg or diastolic BP 100+ mmHg], medical intervention 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 2019-01-11 11:14:30.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) HYPERTSN
C59123 Hair thinning indicate code HairThinningIndCode Code indicating whether the patient has thinning hair Code indicating whether the patient has thinning hair Does the patient have thinning hair? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2019-01-17 07:21:13.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) THINHAIR
C58972 Etiology liver abnormality infection indicate code EtiolLivrAbnrmInfctnIndCode Code indicating whether the etiology of the liver abnormality was determined to be an infection. Code indicating whether the etiology of the liver abnormality was determined to be an infection. Etiology: infection 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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Acute GVHD Form (GVH) LIVETINF
C59078 Pain right upper quadrant indicate code PnRtUpQuadIndCode Code indicating whether pain in the right upper quadrant indicative of abnormal liver function is exhibited by the patient. Code indicating whether pain in the right upper quadrant indicative of abnormal liver function is exhibited by the patient. Right upper quadrant pain 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 Proposed 1.00 2019-01-11 14:24:51.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) RTQUADPN
C59056 Hemorrhage grade HemorrhageGrade Grade of hemorrhage Grade of hemorrhage Hemorrhage 0;3;4;5 Grades 0–2;Transfusion, radiologic, endoscopic, or elective operative intervention 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 2019-01-11 10:20:17.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) HEMORRHG
C59102 Fever grade FeverGrade Grade of fever exhibited by the patient Grade of fever exhibited by the patient Fever 0;3;4;5 Grades 0–2;>40.0 degrees C (>104.0 degrees F) for <= 24 hours;>40.0 degrees C (>104.0 degrees F) for > 24 hours;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 14:30:15.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXFEVER
C59113 Iron overload grade IronOverloadGrade Grade of iron overload exhibited by the patient. Grade of iron overload exhibited by the patient. Iron overload 0;3;4;5 Grades 0–2;Severe symptoms, intervention indicated;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 12:03:06.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) IRONOVER
C59067 Dyspnea grade DyspneaGrade Grade of dyspnea exhibited by the patient. Grade of dyspnea exhibited by the patient. Dyspnea 0;3;4;5 Grades 0–2;Shortness of breath at rest, 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 11:28:38.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXDYSPNA
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 Proposed 1.00 2019-01-17 07:23:04.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Acute GVHD Form (GVH) LIVETVOD
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 Proposed 1.00 2019-01-11 14:28:31.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXWGHTGN
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 Proposed 1.00 2019-01-11 10:27:10.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

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 Proposed 1.00 2019-01-15 14:38:17.0 Toxicity Form Outcomes and End Points Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) MAPARASH
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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) ALLOANTB
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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXXIPS
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 Cardiac Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Acute GVHD Form (GVH) LIVETOTH
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