CDE Detailed Report
Subdomain Name: Hospital/Care Management
CRF: Adverse Events
Displaying 1 - 17 of 17
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C60386 | Adverse event site aware date and time | AdvrsEvntSiteAwareDateTime | Date (and time, if applicable and known) on which the site first became aware of the adverse event | Date (and time, if applicable and known) on which the site first became aware of the adverse event | Site AE Awareness Date | Date or Date & Time |
Record the date and time the site became aware of the adverse event. 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). |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:51:05 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Free-Form Entry |
||||||||||
| C60387 | Adverse event ongoing indicator | AdvrsEvntOngoingInd | Indicator of whether the adverse event experienced by the participant is ongoing | Indicator of whether the adverse event experienced by the participant is ongoing | Ongoing? | No;Yes | No;Yes | Alphanumeric |
Choose No or Yes. If NO, record date of resolution. |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:51:06 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
||||||||
| C60388 | Adverse event severity intensity CDISC grade | AdvrsEvntSeverIntnstCDISCGrade | Grade of severity or intensity of the adverse event according to the Clinical Data Interchange Standards Consortium (CDISC) terminologies | Grade of severity or intensity of the adverse event according to the Clinical Data Interchange Standards Consortium (CDISC) terminologies | Severity | Mild;Moderate;Severe | Mild;Moderate;Severe | Alphanumeric |
Choose the one severity that best describes the investigator?s assessment of the intensity of the AE. The three severity grades are from the Clinical Data Interchange Standards Consortium (CDISC) terminologies. Severe events interrupt the participant?s normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating. Consequently, a change in severity may constitute a new reportable AE. Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day?s hospitalization and thus is an SAE. It is helpful to define the severity categories in the protocol or Manual of Operations to obtain consistency in reporting across sites. |
Clinical Data Interchange Standards Consortium (CDISC) (https://www.cdisc.org/kb/ecrf/adverse-events) | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:51:07 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
||||||||
| C60389 | Adverse event study intervention action take type other text | AdvEvntStdyIntrvntActTakTypOTH | The free-text field related to 'Adverse event study intervention action take type', specifying other text. Type of action taken for adverse event in relation to study intervention | The free-text field related to 'Adverse event study intervention action take type', specifying other text. Type of action taken for adverse event in relation to study intervention | Other, specify | Alphanumeric |
This CDE is only appropriate for clinical trials and should be removed from the CRF if a study does not have an intervention. |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:51:10 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations | 4000 |
Free-Form Entry |
|||||||||
| C02300 | Adverse event study intervention action take type | AdvEvntStdyIntrvntActTakTyp | Type of action taken for adverse event in relation to study intervention | Type of action taken for adverse event in relation to study intervention | Action Taken with Study Intervention | None;Study Intervention Interrupted;Study Intervention Discontinued;Study Intervention Modified;Other, specify | None;Study Intervention Interrupted;Study Intervention Discontinued;Study Intervention Modified;Other, specify | Alphanumeric |
Choose one. This CDE is only appropriate for clinical trials and should be removed from the CRF if a study does not have an intervention. |
No references available | Adult;Pediatric | Supplemental | 4 | 10/16/2024 8:51:09 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
3141289 | |||||||
| C18659 | Unexpected adverse event indicator | UnexpectAdvrsEvntInd | Indicator of whether the adverse event is unexpected | Indicator of whether the adverse event is unexpected | Unexpected Adverse Event? | No;Yes | No;Yes | Alphanumeric |
Choose No or Yes. This question should be answered YES if the AE was not previously identified as an adverse event associated with use of the investigational drug or medical device, based on those described in the Investigator?s Brochure. An event may also be identified as unexpected if the adverse event increased in frequency or severity than what is described by the Investigator?s Brochure. |
No references available | Adult;Pediatric | Supplemental | 1.1 | 10/16/2024 8:51:00 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
||||||||
| C02301 | Adverse event end date and time | AdverseEvntEndDateTime | Date (and time, if applicable and known) on which the adverse event discontinued/stopped | Date (and time, if applicable and known) on which the adverse event discontinued/stopped | Resolution Date | Date or Date & Time |
Record the date (and time) the adverse event stopped or worsened. 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 an AE worsens, record an end date/time and create a new AE record with a new start date/time and severity. |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:06 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Free-Form Entry |
2189843 | |||||||||
| C22702 | Institutional review board notification indicator | IRBNotifInd | Indicator of whether the Institutional Review Board (IRB) was notified following an adverse event | Indicator of whether the Institutional Review Board (IRB) was notified following an adverse event | IRB notified | No;Yes | No;Yes | Alphanumeric |
No: Not needed now because was not serious but will be reported at annual review; Yes: Required if serious. |
Adult;Pediatric | Supplemental | 3.00 | 7/18/2013 2:26:07 PM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
3171540 | ||||||||
| C02302 | Adverse event other action take type | AdvEvntOthrActionTakeTyp | Type of action taken due to adverse event other than action taken with study intervention/ treatment | Type of action taken due to adverse event other than action taken with study intervention/ treatment | Other Action Taken | None;Non-Study Treatment Required | None;Non-Study Treatment Required | Alphanumeric |
Choose one. If non-study medical treatment was required, then the corresponding medication(s) needs to be recorded on the Prior and Concomitant Medications CRF. If non-study interventions other than medications were required, they need to be documented on the appropriate study-specific CRF. |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:11 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
3141322 | |||||||
| C02303 | Adverse event outcome status | AdvrsEvntOutcomStatus | Final status of the participant related to the adverse event | Final status of the participant related to the adverse event | Outcome Attributed to the Event | Recovered/Resolved;Recovered/Resolved with Sequelae;Recovering/Resolving;Not Recovered/Not Resolved;Fatal | Recovered/Resolved;Recovered/Resolved with Sequelae;Recovering/Resolving;Not Recovered/Not Resolved;Fatal | Alphanumeric |
Choose one. The outcome of an AE may not be captured at the visit during which it was first reported, but must be captured to provide a complete picture of the event. Entering the outcome of an AE may be deferred until the AE is resolved, or the participant completes the study. For AEs that have not resolved at the time of a study visit, the outcome should be marked as ?Not recovered/Not resolved? on the AE CRF. |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:11 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
2746517 | |||||||
| C02304 | Adverse event study intervention relatedness investigator assessment grade | AdvrsEvntStdyIntRltInvAstGrade | Grade of the causality between the treatment modality/intervention and the specific adverse event | Grade of the causality between the treatment modality/intervention and the specific adverse event | Investigator Assessment of Study Intervention Causality | Unrelated;Unlikely;Definite;Probable;Possible | Unrelated;Unlikely;Definite;Probable;Possible | Alphanumeric |
Choose one. Record the investigator?s assessment as to whether there is at least a reasonable possibility that the AE is related to (or caused by) use of the study intervention. Definitions for each of the relatedness responses should be supplied in the protocol. Permissible values included are from NCI Guidelines: Adverse Event Reporting Requirements (https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs...): Unrelated to investigational agent/intervention Unrelated ? The AE is clearly not related to the intervention Unlikely ? The AE is doubtfully related to the intervention Related to investigational agent/intervention Possible ? The AE may be related to the intervention Probably ? The AE is likely related to the intervention Definite ? The AE is clearly related to the intervention |
NCI Guidelines: Adverse Event Reporting Requirements (https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf) | Adult;Pediatric | Supplemental | 4 | 10/16/2024 8:51:08 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
1285 | |||||||
| C02306 | Adverse event start date and time | AdvrsEvntStartDateTime | Date (and time, if applicable and known) on which the adverse event was first evident | Date (and time, if applicable and known) on which the adverse event was first evident | Onset Date and Time | Date or Date & Time |
Record the date (and time) the adverse event started. 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 a previously recorded AE worsens, a new record should be created with a new start date/time. There should be no AE start date prior to the date of the informed consent. Any AE that started prior to the informed consent date belongs instead in the medical history. If an item recorded on the medical history worsens during the study, the date of the worsening is entered as an AE with the start date/time as the date/time the condition worsened. |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:04 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Free-Form Entry |
2744993 | |||||||||
| C02307 | Adverse event verbatim term text | AdvrsEvntVerbatimTermT xt | The free-text field that describes the adverse event word for word as described by the participant | The free-text field that describes the adverse event word for word as described by the participant | Adverse Event | Alphanumeric |
Any untoward medical occurrence in a study participant that does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study intervention or study procedure, whether or not related to the study intervention or study procedure. Each AE should be listed on a separate line. Any worsening of a baseline condition or reoccurrence of a baseline condition that had previously ended for a time should be listed as an AE. Events, such as nausea and vomiting are considered two events, and therefore should be listed on separate lines. A participant may experience an unexpected AE. An unexpected adverse reaction has a nature or severity of which is not consistent with the study intervention description (e.g. Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). The unexpected AE must be reported, whether related to the study intervention or not, with as much detail as is available. See the Data Dictionary for additional information on coding the adverse events using either the Common Terminology Criteria for Adverse Events (CTCAE) or the Medical Dictionary for Regulatory Activities (MedDRA). |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:33 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations | 4000 |
Free-Form Entry |
2188132 | ||||||||
| C02308 | Adverse event during study indicator | AdvrsEvntDuringStudyInd | Indicator of whether the participant experienced any adverse events during the study | Indicator of whether the participant experienced any adverse events during the study | Has the participant had any adverse events during the study? | Yes;No | Yes;No | Alphanumeric |
Choose one. If answered Yes, at least one AE must be recorded. |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:02 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
2188132;3177812 | |||||||
| C02309 | Serious adverse event indicator | SeriousAdvrsEvntInd | Indicator of whether the adverse event is serious | Indicator of whether the adverse event is serious | Serious Adverse Event? | Yes;No | Yes;No | Alphanumeric |
Choose either No or Yes. This question should only be answered YES if the outcome of the AE results in at least one of the following: death; a life-threatening experience; results in inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; or an important medical event. If an AE is serious, this provides a trigger that additional information must be provided by the site investigator. The site investigator then completes a Serious Adverse Event (SAE) form. Additionally, the site institution and/or IRB may also have an SAE form and procedures for reporting SAEs. |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:29 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations |
Single Pre-Defined Value Selected |
2199908 | |||||||
| C02310 | Adverse event CTCAE term name | AdvrsEvntCTCAETermName | Name that represents the Common Terminology Criteria for Adverse Events (CTCAE) term for an adverse event | Name that represents the Common Terminology Criteria for Adverse Events (CTCAE) term for an adverse event | Adverse Event | Alphanumeric |
Code the adverse event verbatim text with the Common Terminology Criteria for Adverse Events (CTCAE) term name. CTCAE is a freely available standard terminology for adverse event data. |
Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm) | Adult;Pediatric | Supplemental | 4 | 10/16/2024 8:50:33 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations | 255 |
Free-Form Entry |
3125302 | ||||||||
| C02311 | Adverse event MedDRA lowest level term code | AdvsEvntMedDRALowstLvlTermCode | Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lowest Level Term (LLT) for an adverse event | Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lowest Level Term (LLT) for an adverse event | Adverse Event | Alphanumeric |
Code the adverse event verbatim text with the Medical Dictionary for Regulatory Activities (MedDRA) Lowest Level Term (LLT) codes. |
Medical Dictionary for Regulatory Activities (https://www.meddra.org/index.asp) | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:34 AM | Adverse Events | Hospital/Care Management | Assessments and Examinations | 255 |
Free-Form Entry |
3133353 |
