CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Outcomes and End Points
CRF: Death Form
Sub-Domain: Outcomes and End Points
CRF: Death Form
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59951 | Death cause secondary underlying comorbid reason | DthCsScndyUndlyCmbdRsn | Reason(s) which was/were the secondary/underlying or comorbid cause(s) of the subject/participant's death. | Reason(s) which was/were the secondary/underlying or comorbid cause(s) of the subject/participant's death. | Secondary/underlying or comorbid causes of death from other sources (identify in consultation with PI) (select all that apply): | Infection;Kidney failure;Liver failure;Pulmonary embolism;Trauma;Other, specify;Acute chest syndrome;Respiratory failure;Sudden death;Stroke, ischemic;Stroke, hemorrhagic;Cardiac arrest;Sickle Cell Disease Multiorgan Failure Syndrome;Cancer (specify type, location) | Infection;Kidney failure;Liver failure;Pulmonary embolism;Trauma;Other, specify;Acute chest syndrome;Respiratory failure;Sudden death;Stroke, ischemic;Stroke, hemorrhagic;Cardiac arrest;Sickle Cell Disease Multiorgan Failure Syndrome;Cancer (specify type, location) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 15:35:34.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Multiple Pre-Defined Values Selected |
Sickle Cell Implementation Consortium | Mortality and Survival | |||||||||||||||||||||||||||||
| C59086 | Consent withdrawal date | ConsentWithdrwlDate | Date indicating when patient withdrew consent | Date indicating when patient withdrew consent | Refused further participation (or withdrew consent), date: | Date or Date & Time | Adult;Pediatric | Supplemental | 1.00 | 2019-01-14 14:14:15.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Withdrawal of Consent Form (WOC) | WOCSTPDT | |||||||||||||||||||||||||||||
| C59952 | Cancer death cause primary type anatomic site text | CncrDthCsPrmTypAntSitTxt | Text specifying the type and anatomic site of cancer that was a primary/intermediate cause of the subject/participant's death | Text specifying the type and anatomic site of cancer that was a primary/intermediate cause of the subject/participant's death | Cancer, primary/intermediate cause of death (specify type, location): | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 15:38:46.0 | Death Form | Outcomes and End Points | Mortality/Survival | 255 |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | ||||||||||||||||||||||||||||||
| C59942 | Study withdraw reason | StudyWithdrawRsn | Reason for which the subject/participant withdrew from the study. | Reason for which the subject/participant withdrew from the study. | Refused further participation (or withdrew consent), reason: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 14:47:24.0 | Death Form | Outcomes and End Points | Mortality/Survival | 255 |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | ||||||||||||||||||||||||||||||
| C59953 | Death cause primary intermediate reason other text | DthCsPrmyIntrmdRsnOTH | The free-text field related to 'Death cause primary intermediate reason', specifying other text. | The free-text field related to 'Death cause primary intermediate reason', specifying other text. | Other primary (specify); | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 15:43:19.0 | Death Form | Outcomes and End Points | Mortality/Survival | 4000 |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | ||||||||||||||||||||||||||||||
| C59943 | Study followup loss reason | StudyFollowupLossRsn | Reason for which the subject/participant was lost to study follow-up. | Reason for which the subject/participant was lost to study follow-up. | Lost to follow-up (or cannot be located), reason: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 14:51:51.0 | Death Form | Outcomes and End Points | Mortality/Survival | 255 |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | ||||||||||||||||||||||||||||||
| C59954 | Death cause secondary underlying comorbid reason other text | DthCsScndyUndlyCmbdRsnOTH | The free-text field related to 'Death cause secondary underlying comorbid reason', specifying other text. | The free-text field related to 'Death cause secondary underlying comorbid reason', specifying other text. | Other secondary (specify): | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 15:46:51.0 | Death Form | Outcomes and End Points | Mortality/Survival | 4000 |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | ||||||||||||||||||||||||||||||
| C59944 | Study followup loss date | StudyFollowupLossDate | Date on which the subject/participant was lost to study follow-up. | Date on which the subject/participant was lost to study follow-up. | Lost to follow-up (or cannot be located), date: | Date or Date & Time | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 14:53:53.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | |||||||||||||||||||||||||||||||
| C59955 | Autopsy report available indicator | AutopsyRptAvailableInd | Indicator of whether an autopsy report is available for the deceased subject/participant. | Indicator of whether an autopsy report is available for the deceased subject/participant. | Is an autopsy report available? | No;Yes | No;Yes | Alphanumeric |
Copies of autopsy reports should be maintained locally. |
Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 15:49:17.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Single Pre-Defined Value Selected |
Sickle Cell Implementation Consortium | Mortality and Survival | ||||||||||||||||||||||||||||
| C59945 | Participant living last known date | PrtcpntLvngLstKnwnDate | Date on which the subject/participant was most recently known to be living. | Date on which the subject/participant was most recently known to be living. | Date last known alive: | Date or Date & Time | Adult;Pediatric | Core | 1.00 | 2020-08-19 14:57:14.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | |||||||||||||||||||||||||||||||
| C59956 | Cancer death cause secondary type anatomic site text | CncrDthCsScdTypAntSitTxt | Text specifying the type and anatomic site of cancer that was a secondary/underlying or comorbid cause of the subject/participant's death | Text specifying the type and anatomic site of cancer that was a secondary/underlying or comorbid cause of the subject/participant's death | Cancer, secondary/underlying or comorbid cause of death (specify type, location): | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 15:38:46.0 | Death Form | Outcomes and End Points | Mortality/Survival | 255 |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | ||||||||||||||||||||||||||||||
| C59946 | Death location | DeathLoc | Location at which the subject/participant died. | Location at which the subject/participant died. | Place of death: | Hospital - inpatient stay;Hospital - emergency room;Home;Community;Other, specify;Unknown;Hospice | Hospital - inpatient stay;Hospital - emergency room;Home;Community;Other, specify;Unknown;Hospice | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 15:00:29.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Single Pre-Defined Value Selected |
Sickle Cell Implementation Consortium | Mortality and Survival | |||||||||||||||||||||||||||||
| C59947 | Death cause secondary text | DeathCausSecndryTxt | Text identifying secondary cause(s) of the subject/participant's death. | Text identifying secondary cause(s) of the subject/participant's death. | Secondary cause(s) of death: | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2020-08-19 15:03:31.0 | Death Form | Outcomes and End Points | Mortality/Survival | 1000 |
Free-Form Entry |
Sickle Cell Implementation Consortium | Mortality and Survival | ||||||||||||||||||||||||||||||
| C02203 | Off study reason | OffStdyRsn | Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). | Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). | Event: | Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died | Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died | Alphanumeric | Adult;Pediatric | Core | 3.00 | 2013-07-18 16:35:19.49 | Death Form | Outcomes and End Points | Mortality/Survival |
Single Pre-Defined Value Selected |
2979313 | DeBaun Forms | |||||||||||||||||||||||||||||
| C59948 | Death cause source | DeathCauseSource | Source from which the cause of the subject/participant's death was obtained. | Source from which the cause of the subject/participant's death was obtained. | Source of cause of death (select all that apply): | Medical record;Autopsy report;Death certificate;Family member | Medical record;Autopsy report;Death certificate;Family member | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2020-08-19 15:06:04.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Multiple Pre-Defined Values Selected |
Sickle Cell Implementation Consortium | Mortality and Survival | |||||||||||||||||||||||||||||
| C04800 | Death cause text | DeathCauseTxt | Text describing the primary reason or cause of the participant/subject's death. If possible, this should be the explanation of the cessation of life according to the Death Certificate. | Text describing the primary reason or cause of the participant/subject's death. If possible, this should be the explanation of the cessation of life according to the Death Certificate. | Primary cause of death: | Alphanumeric | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Death Form | Outcomes and End Points | Mortality/Survival | 255 |
Free-Form Entry |
3142852 | |||||||||||||||||||||||||||||||
| C59949 | Death related or complication sickle cell disease gene therapy indicator | DthRelOrCmpSCDGnThrInd | Indicator of whether the subject/participant's death was related to or a complication of gene therapy for sickle cell disease (SCD). | Indicator of whether the subject/participant's death was related to or a complication of gene therapy for sickle cell disease (SCD). | Was the death related to, or a complication of, gene therapy for sickle cell disease? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2020-08-19 15:15:51.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Single Pre-Defined Value Selected |
Sickle Cell Implementation Consortium | Mortality and Survival | |||||||||||||||||||||||||||||
| C18862 | Death location other text | DeathLoctnOTH | The free-text field related to 'Death location type' specifying other text. Type of location where the participant/subject died | The free-text field related to 'Death location type' specifying other text. Type of location where the participant/subject died | Place of death: other, specify: | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Death Form | Outcomes and End Points | Mortality/Survival | 4000 |
Free-Form Entry |
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| C59950 | Death cause primary intermediate reason | DthCsPrmyIntrmdRsn | Reason which was the primary or intermediate cause of death of the subject/participant. | Reason which was the primary or intermediate cause of death of the subject/participant. | Primary/intermediate cause of death from other sources (identify in consultation with PI) (select one): | Infection;Kidney failure;Liver failure;Pulmonary embolism;Trauma;Other, specify;Acute chest syndrome;Respiratory failure;Sudden death;Stroke, ischemic;Stroke, hemorrhagic;Cardiac arrest;Sickle Cell Disease Multiorgan Failure Syndrome;Cancer (specify type, location) | Infection;Kidney failure;Liver failure;Pulmonary embolism;Trauma;Other, specify;Acute chest syndrome;Respiratory failure;Sudden death;Stroke, ischemic;Stroke, hemorrhagic;Cardiac arrest;Sickle Cell Disease Multiorgan Failure Syndrome;Cancer (specify type, location) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2020-08-19 15:24:48.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Single Pre-Defined Value Selected |
Sickle Cell Implementation Consortium | Mortality and Survival | |||||||||||||||||||||||||||||
| C58800 | Death date | DeathDate | Date on which the subject/participant died | Date on which the subject/participant died | Date of death: | Date or Date & Time | Adult;Pediatric | Core | 1.00 | 2018-12-12 12:24:18.0 | Death Form | Outcomes and End Points | Mortality/Survival |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up Status Form - 1507 (F23) | F23DTHDT |
20 results.