CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Toxicity Form

71 results.
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
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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other 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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) CAPLKSYN
71 results.
CSV