CDE Detailed Report

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

Displaying 1 - 39 of 39
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 / 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
C12232 Laboratory director name LabDirectorName Name of laboratory director where assessment was performed Name of laboratory director where assessment was performed Principal Investigator's name and address Alphanumeric

(please specify)

Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Serious Adverse Events Adverse Events Safety Data 255

Free-Form Entry

C20398 Serious adverse event medication administration text SerAdvrsEvntMedAdmText The free-text field to describe the administration of study intervention. The free-text field to describe the administration of study intervention. Describe administration of study intervention (e.g. dose, frequency and route used for a drug) Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data 4000

Free-Form Entry

2630200
C20409 Adverse event attribution indicator AdvrsEvntAttrInd Indicator of whether the adverse event was cause by the treatment in question. Indicator of whether the adverse event was cause by the treatment in question. Based on the sponsor's assessment, is there at least a reasonable possibility that the adverse event was caused by use of the investigational agent or device? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-03-23 14:58:59.0 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C00008 Age value AgeVal Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject. Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject. Age Numeric Values

(please provide)

Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Serious Adverse Events Adverse Events Safety Data

Free-Form Entry

0 1800 month
C17447 Event description text EvntDescrTxt The free-text field to describe the event. The free-text field to describe the event. Describe event or problem Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Serious Adverse Events Adverse Events Safety Data 255

Free-Form Entry

C20399 Serious averse event end treatment indicator SerAdvrsEvntEndTxInd Indicate whether the study was discontinued due to the serious adverse event. Indicate whether the study was discontinued due to the serious adverse event. Was study intervention discontinued due to the event? Yes;No;N/A Yes;No;N/A Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C20410 Serious adverse event not resolution indicator SerAdvrsEvntRslnInd Indicates whether the adverse event was not resolved. Indicates whether the adverse event was not resolved. Resolution Date (Not applicable) Not resolved Not resolved Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C01522 Height measurement HgtMeasr Measurement of participant's/subject's height. Measurement of participant's/subject's height. Height Numeric Values

(please provide)

Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Serious Adverse Events Adverse Events Safety Data

Free-Form Entry

0 400 centimeter 649
C18659 Unexpected adverse event indicator UnexpectAdvrsEvntInd The indicator of whether the adverse event is unexpected The indicator of whether the adverse event is unexpected Does this adverse event meet the definition to be an unexpected event? No;Yes No;Yes Alphanumeric

Unexpected: An adverse event is categorized by the sponsor as "unexpected" because the adverse event has not been previously described in the Investigator's Brochure or has increased in frequency or severity compared to what is described by the Investigator's Brochure.

Adult;Pediatric Supplemental 1.00 2014-01-30 00:00:00.0 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C20400 Serious adverse event resolution indicator SerAdvrsEvntResolInd Indicator to ask whether an adverse event ended after treatment with the study protocol drug or agent was stopped. Indicator to ask whether an adverse event ended after treatment with the study protocol drug or agent was stopped. Was the seriousness of the event abated after discontinuation of the study intervention? Yes;No;N/A Yes;No;N/A Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C20411 Serious adverse event outcome status other text SerAdvrsEvntOutStatOthTxt Free-text field to specify an alternate outcome attributed to the serious adverse event. Free-text field to specify an alternate outcome attributed to the serious adverse event. Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2015-03-24 10:00:30.0 Serious Adverse Events Adverse Events Safety Data 2000

Free-Form Entry

C01541 Weight measurement WgtMeasr Measurement of participant's/subject's weight Measurement of participant's/subject's weight Weight Numeric Values

(please provide)

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data

Free-Form Entry

0 500 kilogram 2179689
C19256 Study protocol name StudyProtocolName Name of study protocol Name of study protocol Name of study intervention Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-05 16:38:14.0 Serious Adverse Events Adverse Events Safety Data 4000

Free-Form Entry

C20401 Serious adverse event reappearance indicator SerAdvrsEvntReappInd Indicate whether the adverse event reappeared after the treatment was restarted. Indicate whether the adverse event reappeared after the treatment was restarted. Did event reappear after reintroduction of the study intervention? Yes;No;N/A Yes;No;N/A Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C20412 Serious adverse event outcome status SerAdvrsEvntOutcomStatus Final status of the participant/subject related to the serious adverse event Final status of the participant/subject related to the serious adverse event Outcomes attributed to event Congenital anomaly/birth defect;Death on;In-patient hospitalization/prolongation of present hospitalization;Life-threatening event;Other, specify:;Persistent or significant disability/incapacity;Required intervention to prevent permanent impairment/damage Congenital anomaly/birth defect;Death on;In-patient hospitalization/prolongation of present hospitalization;Life-threatening event;Other, specify:;Persistent or significant disability/incapacity;Required intervention to prevent permanent impairment/damage Alphanumeric

(check all that apply)

Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

2746517
C01581 Weight unit of measure WgtUoM Unit of measure for the weight numerical value Unit of measure for the weight numerical value Weight (unit of measure) Pounds;Kilograms Pounds;Kilograms Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

2630200
C20391 Sex type SexTyp The sex of the subject/participant The sex of the subject/participant Sex Male;Female Male;Female Alphanumeric Adult;Pediatric Supplemental 4.00 2013-07-25 16:35:19.0 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C20402 Serious adverse event blind broken indicator SerAdvrsEvntBlindBrokInd Indicate whether the study blind was broken. Indicate whether the study blind was broken. Was the study blind broken? Yes;No;N/A Yes;No;N/A Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C20413 Investigator assessment concomitant medication specify text InvestAssessConcomMedSpecTxt The free-text field to specify the concomitant medication that might have caused the serious adverse event. The free-text field to specify the concomitant medication that might have caused the serious adverse event. Specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data 2000

Free-Form Entry

2630200
C01582 Height unit of measure HgtUOM Unit of measure for the height numerical value for subject/participant Unit of measure for the height numerical value for subject/participant Height (unit of measure) Inches;Centimeters Inches;Centimeters Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

2538920
C20392 Serious adverse event treatment description text SerAdvrsEvntTxDescText The text that describes the interventions specific to the serious adverse event. The text that describes the interventions specific to the serious adverse event. Record treatment for event Alphanumeric

Data to be filled in by site

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data 4000

Free-Form Entry

2630200
C20403 Serious adverse event investigator assessment SerAdvrsEvntInvAssess Indicate the principal investigator's opinion of the cause of the event. Indicate the principal investigator's opinion of the cause of the event. Principal Investigator's Opinion of what caused the event Study intervention;Concomitant medication;Concurrent disorder;Withdrawal of study intervention Study intervention;Concomitant medication;Concurrent disorder;Withdrawal of study intervention Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

C20414 Investigator assessment intervention withdrawal specify text InvestAssessIntrvWthdrlSpecTxt The free-text field to specify the details of the withdrawal of study intervention that might have caused the serious adverse event. The free-text field to specify the details of the withdrawal of study intervention that might have caused the serious adverse event. Specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data 4000

Free-Form Entry

2630200
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 Events Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Serious Adverse Events Adverse Events Safety Data 4000

Free-Form Entry

2188132
C20393 Serious adverse event start date and time SerAdvrsEvntStartDateTime Date (and time, if applicable and known) on which the serious adverse event was first evident Date (and time, if applicable and known) on which the serious adverse event was first evident Date of Onset Date or Date & Time

(mm/dd/yyyy)

Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Serious Adverse Events Adverse Events Safety Data

Free-Form Entry

2744993
C20404 Investigator assessment concurrent disorder specify text InvestAssessConcurDisorSpecTxt The free-text field to specify the concurrent disorder that might have caused the serious adverse event. The free-text field to specify the concurrent disorder that might have caused the serious adverse event. Specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data 2000

Free-Form Entry

2630200
C20415 Serious adverse event report completed date SerAdvrsEvntRprtCompDt Date when the report on the adverse event was completed. Date when the report on the adverse event was completed. Date Report Completed Date or Date & Time

(mm/dd/yyy)

Adult;Pediatric Supplemental 1.00 2015-03-24 11:55:24.0 Serious Adverse Events Adverse Events Safety Data

Free-Form Entry

C02309 Serious adverse event indicator SeriousAdvrsEvntInd The indicator of whether the adverse event is serious. The indicator of whether the adverse event is serious. Does this adverse event meet the definition to be a serious adverse event? Yes;No Yes;No Alphanumeric

Serious: An adverse event is defined by the investigator or sponsor as "serious" because it is life-threatening, results in death, requires in-patient hispitalization, prolongs existing hospitalization, results in persistent or significant disability, or is a congenital anomaly/birth defect.

Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

2199908
C20394 Serious adverse event end date and time SeradvrsEvntEndDateTime Date (and time, if applicable and known) on which the serious adverse event discontinued/stopped Date (and time, if applicable and known) on which the serious adverse event discontinued/stopped Resolution Date Date or Date & Time

(mm/dd/yyyy)

Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Serious Adverse Events Adverse Events Safety Data

Free-Form Entry

2189843
C20405 Serious adverse events anticipated indicator SerAdvrsEvntAnticInd Indicate whether the adverse event was anticipated. Indicate whether the adverse event was anticipated. Was this type of event anticipated in the protcol and consent form? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-03-23 13:23:54.0 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

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. Adverse Events Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Serious Adverse Events Adverse Events Safety Data 255

Free-Form Entry

3125302
C20395 Serious adverse event laboratory data text SerAdvrsEvntLabDataText The text that describes the relevant tests or laboratory data specific to the serious adverse event. The text that describes the relevant tests or laboratory data specific to the serious adverse event. Record relevant tests or laboratory data Alphanumeric

Data to be filled in by site; record relevant tests or laboratory data, including dates or attach the appropriate documentation.

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data 4000

Free-Form Entry

2630200
C20406 Serious adverse events comment text SerAdvrsEvntCmntTxt Provide any additional information that pertains to the adverse event. Provide any additional information that pertains to the adverse event. Comments Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Serious Adverse Events Adverse Events Safety Data 255

Free-Form Entry

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 Adverse Events Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Serious Adverse Events Adverse Events Safety Data 255

Free-Form Entry

3133353
C20396 Serious adverse event concomitant medications text SerAdvrsEvntConcomMedText The text that describes the concomitant medications taken. The text that describes the concomitant medications taken. Record concomitant medications Alphanumeric

Data to be filled in by site; record concomitant medications or attach the appropriate Case Report Form (CRF) page(s).

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data 2000

Free-Form Entry

2630200
C20407 Adverse event reporting identifier name AdvrsEvntRepIdName A name of an authorized group or person reporting the adverse event. A name of an authorized group or person reporting the adverse event. Reporter name and telephone number Alphanumeric

(please specify)

Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Serious Adverse Events Adverse Events Safety Data 255

Free-Form Entry

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

(mm/dd/yyyy)

Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Serious Adverse Events Adverse Events Safety Data

Free-Form Entry

2004152
C20397 Serious adverse event relevant history text SerAdvrsEvntRelHisText The text that describes relevant history including pre-existing medical conditions. The text that describes relevant history including pre-existing medical conditions. Record relevant history including pre-existing medical conditions Alphanumeric

Data to be filled in by site; record medical history inclusing pre-existing medical conditionsor attach appropriate CRF page(s):

Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Serious Adverse Events Adverse Events Safety Data 4000

Free-Form Entry

2630200
C20408 Serious adverse event report type SerAdvrsEvntRepTyp Specify which type of report is being completed for the adverse event. Specify which type of report is being completed for the adverse event. Type of report Final report;Follow-up report;Initial report Final report;Follow-up report;Initial report Alphanumeric Adult;Pediatric Supplemental 1.00 2015-03-23 14:24:12.0 Serious Adverse Events Adverse Events Safety Data

Single Pre-Defined Value Selected

CSV