CDE Detailed Report
Disease: Sickle Cell Disease
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
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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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