CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Follow Up Status Form - BMT CTN 1507
Sub-Domain: Additional Proposed Instruments
CRF: Follow Up Status Form - BMT CTN 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other | 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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up Status Form - 1507 (F23) | F23DTHDT | |||||||||||||||||||||||||||||
| 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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
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 - BMT CTN 1507 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up Status Form - 1507 (F23) | F23UAEDT |
20 results.