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 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
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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) HEPTMGLY
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 Vascular 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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Acute GVHD Form (GVH) LIVETGVH
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 Vascular 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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) INFRLRXN
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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) HYPERTSN
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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) INFECTIN
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 Vascular 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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) RTQUADPN
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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) THINHAIR
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 Vascular 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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXFEVER
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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXDYSPNA
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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) IRONOVER
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 Vascular 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 Vascular Function Testing/Status

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 Proposed 1.00 2019-01-17 07:23:04.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) OLGSPERM
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 Vascular 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 Vascular Function Testing/Status

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 Proposed 1.00 2019-01-11 11:32:52.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

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 Proposed 1.00 2019-01-16 12:35:26.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

Single Pre-Defined Value Selected

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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

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 Vascular Function Testing/Status 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 Proposed 1.00 2019-01-15 14:41:05.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

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 Proposed 1.00 2019-01-11 13:17:56.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

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 Proposed 1.00 2019-01-16 12:48:41.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

Single Pre-Defined Value Selected

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 Vascular Function Testing/Status 100

Free-Form Entry

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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

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 Vascular Function Testing/Status

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 Proposed 1.00 2019-01-15 14:23:40.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

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 Proposed 1.00 2019-01-11 13:20:38.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

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 Proposed 1.00 2019-01-16 13:32:44.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

Single Pre-Defined Value Selected

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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

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 Vascular Function Testing/Status

Single Pre-Defined Value Selected

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 Vascular Function Testing/Status 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 Proposed 1.00 2019-01-16 10:23:09.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

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 Proposed 1.00 2019-01-11 13:48:16.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

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 Proposed 1.00 2019-01-16 13:45:25.0 Toxicity Form Outcomes and End Points Vascular Function Testing/Status

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

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

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

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

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

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

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Toxicity Form (T29) TXHYPXIA
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