CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Protocol Experience
CRF: Follow Up Status Form - 1507

20 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
C58811 Infection new diagnose date InfectionNewDiagnoseDate Date on which the subject/participant was diagnosed with a new infection Date on which the subject/participant was diagnosed with a new infection Date of infection Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 12:50:31.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23INFDT
C58801 Red blood cell transfusion not receive last 6 month indicate code RBCTxfusNoRcvLst6MoIndCode Code indicating whether the subject/participant has NOT received a RBC (red blood cell) transfusion in the last 6 months Code indicating whether the subject/participant has NOT received a RBC (red blood cell) transfusion in the last 6 months Has the patient achieved RBC transfusion independence (no transfusion in the past 6 months)? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 12:26:51.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23RBCIN
C58812 Hospitalization indicate code HospitalizationIndCode Code indicating whether the subject/participant has been hospitalized Code indicating whether the subject/participant has been hospitalized Has the patient been hospitalized? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 12:53:51.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23HOSP
C58802 Hemoglobin S measurement HemoglobinSMeasr Measurement of the subject/participant's hemoglobin S (HbS) level, in percent Measurement of the subject/participant's hemoglobin S (HbS) level, in percent Record the patient's HbS level Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 12:30:10.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

0 99.9 percent BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23HMSVL
C58813 Hospitalization not transplant indicate code HospitalztnNotTxpltIndCode Code indicating whether the subject/participant has been hospitalized for a reason other than receiving a transplant Code indicating whether the subject/participant has been hospitalized for a reason other than receiving a transplant Has the patient been hospitalized (other than for transplant) 1;2;1;2 Yes;No;Yes;No Numeric Values

If Yes, a Re-Admission Form must be submitted.

Adult;Pediatric Proposed 1.00 2018-12-12 12:56:45.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23HOSP
C58803 Hemoglobin S measurement date HemoglobinSMeasrDate Date on which the subject/participant's hemoglobin S (HbS) level was measured Date on which the subject/participant's hemoglobin S (HbS) level was measured Date HbS level obtained Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 12:32:37.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23HSVDT
C58814 Hospitalization date HospitalizationDate Date on which the subject/participant was hospitalized Date on which the subject/participant was hospitalized Date of hospitalization Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 12:59:23.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23HSPDT
C58804 Red blood cell transfusion most recent date RBCTxfusMostRecentDate Date of the subject/participant's most recent RBC (red blood cell) transfusion Date of the subject/participant's most recent RBC (red blood cell) transfusion Date of most recent RBC transfusion Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 12:34:37.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23RBCDT
C58815 Adverse event grade 3 5 unexpected indicate code AdvEvtGrd35UnexpctIndCode Code indicating whether the subject/participant has experienced any unexpected Grade 3–5 Adverse Events Code indicating whether the subject/participant has experienced any unexpected Grade 3–5 Adverse Events Has the patient experienced any Unexpected, Grade 3-5 Adverse Events? 1;2;1;2 Yes;No;Yes;No Numeric Values

If Yes, an Unexpected, Grade 3-5 Adverse Event Form must be submitted.

Adult;Pediatric Proposed 1.00 2018-12-12 13:01:31.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23UAE
C58805 Secondary graft failure indicate code SecndryGraftFailurIndCode Code indicating whether the subject/participant has experienced a secondary graft failure Code indicating whether the subject/participant has experienced a secondary graft failure Has the patient experienced secondary graft failure? 1;2;1;2 Yes;No;Yes;No Numeric Values

If Yes, a Secondary Graft Failure Form must be submitted.

Adult;Pediatric Proposed 1.00 2018-12-12 12:36:49.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23SCGRF
C58816 Adverse event grade 3 5 unexpected date AdvEvtGrd35UnexpctDate Date on which the subject/participant experienced an unexpected Grade 3–5 Adverse Event Date on which the subject/participant experienced an unexpected Grade 3–5 Adverse Event Date of onset of Unexpected, Grade 3-5 Adverse Event Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 13:03:22.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23UAEDT
C58806 Donor cell at secondary graft failure percent value DonrCelAtScndyGrftFailurPctVal Value in percent of donor cells at the time of secondary graft failure Value in percent of donor cells at the time of secondary graft failure Record the percentage of donor cells at the time of secondary graft failure Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 12:39:01.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

0 99 percent BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23DNHMC
C58807 Secondary graft failure sample date SecndryGraftFailurSampleDate Date on which the sample pertaining to secondary graft failure was taken Date on which the sample pertaining to secondary graft failure was taken Date sample obtained Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 12:42:25.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23DNHDT
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 Follow Up Status Form - 1507 Protocol Experience Study Management 4000

Free-Form Entry

DeBaun Forms
C58808 Hematopoietic cell second infusion indicate code HmtpoietcCel2ndInfusIndCode Code indicating whether the subject/participant has received a second infusion of hematopoietic cells Code indicating whether the subject/participant has received a second infusion of hematopoietic cells Has the patient had a second infusion of hematopoietic cells (with or without preparative regimen)? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-12 12:44:40.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23SECCL
C58749 Last contact date LastContactDate Indicate the date of the last study visit. Indicate the date of the last study visit. Date of last contact: Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-10 09:46:30.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 SCD Events of Special Interest Form (ESI) ESICNTDT
C58809 Hematopoietic cell second infusion date HmtpoietcCel2ndInfusDate Date on which the subject/participant received a second infusion of hematopoietic cells Date on which the subject/participant received a second infusion of hematopoietic cells Date of second infusion of hematopoietic cells Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 12:46:32.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23SECDT
C58799 Death indicate code DeathIndCode Code indicating whether the subject/participant has died Code indicating whether the subject/participant has died Has the patient died? 1;2;1;2 Yes;No;Yes;No Numeric Values

If Yes, a Death Form must be submitted.

Adult;Pediatric Proposed 1.00 2018-12-12 12:21:58.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23DEATH
C58810 Infection new indicate code InfectionNewIndicateCode Code indicating whether the subject/participant has experienced any new infections Code indicating whether the subject/participant has experienced any new infections Has the patient experienced any new clinically significant infections? 1;2;1;2 Yes;No;Yes;No Numeric Values

If Yes, an Infection Form must be submitted.

Adult;Pediatric Proposed 1.00 2018-12-12 12:48:54.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23NWINF
C58800 Death date DeathDate Date on which the subject/participant died Date on which the subject/participant died Date of patient death Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-12 12:24:18.0 Follow Up Status Form - 1507 Protocol Experience Study Management

Free-Form Entry

BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23DTHDT
20 results.
CSV