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
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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other 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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other 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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

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 Additional Proposed Instruments Other

Single Pre-Defined Value Selected

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