CDE Detailed Report

Disease: content
Subdomain Name: Clinical Event End Points
CRF: welcome

Displaying 1 - 6 of 6
CDE ID CDE Name Variable Name Definition Short Description 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 / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C22780 Date time clock type DateTimeClockTyp Type of clock used to record date and time Type of clock used to record date and time Date and Time of Death am;PM;24-hour clock am;PM;24-hour clock Alphanumeric

Record the date (and time) of death and verify with the death certificate if possible. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://www.iso.org/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in an unambiguous format acceptable to the study database like DD-MMM-YYYY. When date/time data are prepared for aggregation or sharing, they should be converted to the format specified by ISO 8601; YYYY-MM-DD T:hh:mm:ss (https://www.iso.org/iso-8601-date-and-time-format.html). If uncertainty exists on the occurrence of death or date of death, confirm death and date of death using vital status search, such as the Social Security Death Index in the US.

No references available Adult;Pediatric Supplemental 1.1 10/16/2024 8:50:25 AM Death Report Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C60367 Autopsy indicator AutopsyInd Indicator of whether an autopsy was performed Indicator of whether an autopsy was performed Was an autopsy performed? No;Yes No;Yes Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1 10/16/2024 8:50:27 AM Death Report Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C60368 Death certificate status DeathCertificateStat Status of the participant's death certificate Status of the participant's death certificate Death Certificate Provided;Requested;Not Available;Status Unknown Provided;Requested;Not Available;Status Unknown Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 1 10/16/2024 8:50:28 AM Death Report Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C04800 Death cause text DeathCauseTxt Text describing the primary reason or cause of the participant'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's death. If possible, this should be the explanation of the cessation of life according to the Death Certificate Cause of Death Alphanumeric

Record what the death certificate lists as the official cause of death. Record the cause or causes of death using explanatory text and the associated ICD-10-CM code. Include the primary cause of death first followed by any secondary causes.

No references available Adult;Pediatric Supplemental 3.1 10/16/2024 8:50:25 AM Death Report Clinical Event End Points Outcomes and End Points 255

Free-Form Entry

3142852
C04802 Death date and time DeathDateTime Date (and time, if known) of participant's death Date (and time, if known) of participant's death Date and Time of Death Date or Date & Time

Record the date (and time) of death and verify with the death certificate if possible. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (https://www.iso.org/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in an unambiguous format acceptable to the study database like DD-MMM-YYYY. When date/time data are prepared for aggregation or sharing, they should be converted to the format specified by ISO 8601; YYYY-MM-DD T:hh:mm:ss (https://www.iso.org/iso-8601-date-and-time-format.html). If uncertainty exists on the occurrence of death or date of death, confirm death and date of death using vital status search, such as the Social Security Death Index in the US.

No references available Adult;Pediatric Supplemental 3.1 10/16/2024 8:50:24 AM Death Report Clinical Event End Points Outcomes and End Points

Free-Form Entry

2004152
C21665 Death cause ICD-10-CM code DeathCauseICD10CMCode ICD-10-CM code that describes the cause of participant's death ICD-10-CM code that describes the cause of participant's death ICD-10-CM Code Alphanumeric

Record what the death certificate lists as the official cause of death. Record the cause or causes of death using explanatory text and the associated ICD-10-CM code. Include the primary cause of death first followed by any secondary causes.

No references available Adult;Pediatric Supplemental 3.1 10/16/2024 8:50:26 AM Death Report Clinical Event End Points Outcomes and End Points 255

Free-Form Entry

CSV