CDE Detailed Report
Subdomain Name: Adverse Events
CRF: Adverse Event Tracking Log
Displaying 1 - 13 of 13
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 Yes or No. 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 adverse drug experience; results in inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; or a congenital anomaly/birth defect. 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 Event Tracking Log | Adverse Events | Safety Data |
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 | Alphanumeric |
Code the adverse event verbatim text with the Common Terminology Criteria for Adverse Events (CTCAE) low level term name. CTCAE is a freely available standard terminology for adverse event data. |
Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html) | Adult;Pediatric | Supplemental | 4 | 10/16/2024 8:50:33 AM | Adverse Event Tracking Log | Adverse Events | Safety Data | 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 | Alphanumeric |
Code the adverse event verbatim text with the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) codes. |
Medical Dictionary for Regulatory Activities (http://www.meddramsso.com/index.asp) | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:34 AM | Adverse Event Tracking Log | Adverse Events | Safety Data | 255 |
Free-Form Entry |
3133353 | |||||||||
| 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 | None;Study Intervention Interrupted;Study Intervention Discontinued;Study Intervention Modified | Alphanumeric |
Choose one. If treatment was required, then the corresponding treatment needs to be recorded on the Prior and Concomitant Medications CRF. |
No references available | Adult;Pediatric | Supplemental | 4 | 10/16/2024 8:51:09 AM | Adverse Event Tracking Log | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
3141289 | |||||||
| C14272 | Adverse event AED action taken text | AdverseEventAEDActTxt | Text of action taken with the anti-epileptic drug (AED) due to the adverse event | Text of action taken with the anti-epileptic drug (AED) due to the adverse event | Alphanumeric |
Choose one. |
No references available | Adult;Pediatric | Supplemental | 1.00 | 2012-10-05 00:00:00.0 | Adverse Event Tracking Log | Adverse Events | Safety Data | 255 |
Free-Form Entry |
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| 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 | End Date | Date or Date & Time |
Record the date (and time) the adverse event stopped or worsened. If an AE worsens, record an end date and create a new AE record with a new start date and severity. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/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.). |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:06 AM | Adverse Event Tracking Log | Adverse Events | Safety Data |
Free-Form Entry |
2189843 | |||||||||
| C18659 | Unexpected adverse event indicator | UnexpectAdvrsEvntInd | Indicator of whether the adverse event is unexpected | Indicator of whether the adverse event is unexpected | Serious Adverse Event | No;Yes | No;Yes | Alphanumeric |
Choose Yes or No. 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 Event Tracking Log | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
||||||||
| 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 | Recovered/Resolved;Recovered/Resolved with Sequelae;Recovering/Resolving;Not Recovered/Not Resolved;Fatal;Unknown | Recovered/Resolved;Recovered/Resolved with Sequelae;Recovering/Resolving;Not Recovered/Not Resolved;Fatal;Unknown | Alphanumeric |
Choose one outcome. The outcome of an AE may not be captured at the visit during which it was first reported, but must eventually 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/subject 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 case report form. |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:11 AM | Adverse Event Tracking Log | Adverse Events | Safety Data |
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 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. |
No references available | Adult;Pediatric | Supplemental | 4 | 10/16/2024 8:51:08 AM | Adverse Event Tracking Log | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
1285 | |||||||
| C02305 | Adverse event severity scale grade | AdvrsEvntSeverSclGrade | The grading scale of the severity or intensity of the adverse event | The grading scale of the severity or intensity of the adverse event | Severity | Grade 1;Grade 2;Grade 3;Grade 4;Grade 5 | Mild: asymptomatic or mild symtoms, clinical or diagnostic observations only, intervention not indicated.;Moderate: minimal, local or noninvasive intervention indicated, limiting age-appropriate Activities of Daily Living.;Severe or medically significant but not immediately life-threatening: hospitalization or prolongation of hospitalization indicated, disabling, limiting self care Activities of Daily Living;Life-threatening consequences: urgent intervention indicated;Death related to adverse event | Alphanumeric |
Choose the one severity that best describes the investigator's assessment of the intensity of the AE. The five severity grades are from the Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Severe events interrupt the participant's/subject'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. |
Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html) | Adult;Pediatric | Supplemental | 5.00 | 2022-07-29 12:16:09.0 | Adverse Event Tracking Log | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
2201188 | |||||||
| 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 | Start Date | Date or Date & Time |
Record the date (and time) the adverse event started. If a previously recorded AE worsens, a new record should be created with a new start date. 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 as the date the condition worsened. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/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.). |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:04 AM | Adverse Event Tracking Log | Adverse Events | Safety Data |
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/subject 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 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/subject 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. |
No references available | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:33 AM | Adverse Event Tracking Log | Adverse Events | Safety Data | 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/subject 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 Event Tracking Log | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
2188132;3177812 |
