CDE Detailed Report

Disease: content
Sub-Domain: Adverse Events
CRF: welcome

Displaying 1 - 13 of 13
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 External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C02310 Adverse event CTCAE low level term name AdvrsEvntCTCAELowLvlTermName Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event. Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name 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 3.00 2013-08-28 16:08:00.453 Adverse Event Tracking Log Adverse Events Safety Data 255

Free-Form Entry

3125302
C02311 Adverse event MedDRA lower level term code AdvsEvntMedDRALowerLvlTermCode Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower 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 3.00 2013-07-18 16:35:19.49 Adverse Event Tracking Log Adverse Events Safety Data 255

Free-Form Entry

3133353
C02300 Adverse event study intervention action taken type AdvEvntStdyIntrvntActTakenTyp Type of action taken for adverse event in relation to study intervention The 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 3.00 2013-07-18 16:35:19.49 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

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 3.00 2013-07-18 16:35:19.49 Adverse Event Tracking Log Adverse Events Safety Data

Free-Form Entry

2189843
C18659 Unexpected adverse event indicator UnexpectAdvrsEvntInd The indicator of whether the adverse event is unexpected The 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 1.00 2014-01-30 00:00:00.0 Adverse Event Tracking Log Adverse Events Safety Data

Single Pre-Defined Value Selected

C02303 Adverse event outcome status AdvrsEvntOutcomStatus Final status of the participant/subject related to the adverse event Final status of the participant/subject 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 3.00 2013-07-22 09:34:41.527 Adverse Event Tracking Log Adverse Events Safety Data

Single Pre-Defined Value Selected

2746517
C02304 Adverse event relatedness scale AdvrsEvntRelatednessScale Scale of the causality between the treatment modality/intervention and the specific adverse event The scale 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 3.00 2013-07-18 16:35:19.49 Adverse Event Tracking Log Adverse Events Safety Data

Single Pre-Defined Value Selected

1285
C02305 Adverse event severity grade scale AdvrsEvntSeverScale 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 4.00 2013-07-22 09:34:41.527 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 3.00 2013-07-18 16:35:19.49 Adverse Event Tracking Log Adverse Events Safety Data

Free-Form Entry

2744993
C02307 Adverse event verbatim term text AdvrsEvntVerbatimTermText Text that describes the adverse event word for word as described by the participant/subject Adverse event verbatim term text 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 3.00 2013-07-18 16:35:19.49 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/subject experienced any adverse events during the study Indicator of whether the participant/subject 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 3.00 2013-07-18 16:35:19.49 Adverse Event Tracking Log Adverse Events Safety Data

Single Pre-Defined Value Selected

2188132;3177812
C02309 Serious adverse event indicator SeriousAdvrsEvntInd The indicator of whether the adverse event is serious. The 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 3.00 2013-08-28 16:08:00.453 Adverse Event Tracking Log Adverse Events Safety Data

Single Pre-Defined Value Selected

2199908
CSV