CDE Detailed Report
Subdomain Name: Adverse Events
CRF: welcome
Displaying 1 - 43 of 43
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C60379 | Study intervention name | StdyIntrvntnName | Name of study intervention | Name of study intervention | Name of study intervention | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:45 AM | Serious Adverse Events | Adverse Events | Safety Data | 255 |
Free-Form Entry |
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| C60369 | Serious adverse event site aware date and time | SerAdvrsEvntSiteAwareDateTime | Date (and time, if applicable and known) on which the site first became aware of the serious adverse event | Date (and time, if applicable and known) on which the site first became aware of the serious adverse event | Site SAE awareness date | Date or Date & Time |
Record the date and time the site became aware of the serious 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 8:50:30 AM | Serious Adverse Events | Adverse Events | Safety Data |
Free-Form Entry |
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| C60380 | Serious adverse event cause discontinue study indicator | SerAdvrsEvntCseDscntnStdyInd | Indicator of whether the serious adverse event caused the participant to be discontinued from the study | Indicator of whether the serious adverse event caused the participant to be discontinued from the study | Did the adverse event cause the participant to be discontinued from the study? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:49 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60370 | Serious adverse event ongoing indicator | SerAdvrsEvntOngoingInd | Indicator of whether the serious adverse event experienced by the participant is ongoing | Indicator of whether the serious adverse event experienced by the participant is ongoing | Ongoing? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:31 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60381 | Serious adverse event investigator assessment reason other text | SerAdvrsEvntInvAssessRsnOTH | The free-text field related to 'Serious adverse event investigator assessment reason', specifying other text. Reason in the opinion of the principal investigator that is attributed as the cause of the serious adverse event | The free-text field related to 'Serious adverse event investigator assessment reason', specifying other text. Reason in the opinion of the principal investigator that is attributed as the cause of the serious adverse event | Other, specify | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:52 AM | Serious Adverse Events | Adverse Events | Safety Data | 4000 |
Free-Form Entry |
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| C60371 | Serious adverse event result death indicator | SerAdvrsEvntResltDeathInd | Indicator of whether the serious adverse event resulted in death | Indicator of whether the serious adverse event resulted in death | Did the adverse event result in death? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
Clinical Data Interchange Standards Consortium (CDISC) (https://www.cdisc.org/kb/ecrf/adverse-events) | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:35 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60382 | Principal investigator name | PrincipalInvestigatorName | Name of principal investigator | Name of principal investigator | Principal Investigator's name and address | Alphanumeric |
Please specify |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:54 AM | Serious Adverse Events | Adverse Events | Safety Data | 255 |
Free-Form Entry |
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| C60372 | Serious adverse event threaten life indicator | SerAdvrsEvntThreatenLifeInd | Indicator of whether the serious adverse event is life threatening | Indicator of whether the serious adverse event is life threatening | Is the adverse event life threatening? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
Clinical Data Interchange Standards Consortium (CDISC) (https://www.cdisc.org/kb/ecrf/adverse-events) | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:36 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60383 | Principal investigator address text | PrincipalInvestigatorAddrssTxt | The free-text field to specify the principal investigator's address | The free-text field to specify the principal investigator's address | Principal Investigator's name and address | Alphanumeric |
Please specify |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:55 AM | Serious Adverse Events | Adverse Events | Safety Data | 255 |
Free-Form Entry |
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| C60373 | Serious adverse event initial prolong hospital indicator | SerAdvrsEvntIntlPrlngHospInd | Indicator of whether the serious adverse event resulted in initial or prolonged hospitalization for the participant | Indicator of whether the serious adverse event resulted in initial or prolonged hospitalization for the participant | Did the adverse event result in initial or prolonged hospitalization for the participant? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
Clinical Data Interchange Standards Consortium (CDISC) (https://www.cdisc.org/kb/ecrf/adverse-events) | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:37 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60384 | Adverse event report identifier telephone number | AdvrsEvntRepIdTelephoneNum | Telephone number of an authorized group or person reporting the adverse event | Telephone number of an authorized group or person reporting the adverse event | Reporter name and telephone number | Alphanumeric |
Please specify |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:56 AM | Serious Adverse Events | Adverse Events | Safety Data | 25 |
Free-Form Entry |
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| C60374 | Serious adverse event intervention require prevent permanent impairment damage indicator | SerAdvrsEvntIntRqrPrvPrImDmInd | Indicator of whether the serious adverse event required intervention to prevent permanent impairment or damage | Indicator of whether the serious adverse event required intervention to prevent permanent impairment or damage | Did the adverse event require intervention to prevent permanent impairment or damage? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:38 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60385 | Serious adverse event sponsor assessment indicator | SeriousAdvrsEvntSpnsrAssmtInd | Indicator of whether the adverse event is serious, based on the sponsor's assessment | Indicator of whether the adverse event is serious, based on the sponsor's assessment | Does this adverse event meet the definition to be a serious adverse event? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:59 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60375 | Serious adverse event result persistent significant disability incapacity indicator | SerAdvrsEvntRslPrsSgnDsbIncInd | Indicator of whether the serious adverse event resulted in persistent or significant disability or incapacity | Indicator of whether the serious adverse event resulted in persistent or significant disability or incapacity | Did the adverse event result in persistent or significant disability or incapacity? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
Clinical Data Interchange Standards Consortium (CDISC) (https://www.cdisc.org/kb/ecrf/adverse-events) | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:38 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60376 | Serious adverse event associate congenital anomaly birth defect indicator | SerAdvrsEvntAscCngAnmBrtDfcInd | Indicator of whether the serious adverse event is associated with a congenital anomaly or birth defect | Indicator of whether the serious adverse event is associated with a congenital anomaly or birth defect | Is the adverse event associated with a congenital anomaly or birth defect? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
Clinical Data Interchange Standards Consortium (CDISC) (https://www.cdisc.org/kb/ecrf/adverse-events) | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:39 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60377 | Serious adverse event other important medical event indicator | SerAdvrsEvntOthrImptMdcEvntInd | Indicator of whether the serious adverse event is a medically important event not covered by other 'serious' criteria | Indicator of whether the serious adverse event is a medically important event not covered by other 'serious' criteria | Is the adverse event a medically important event not covered by other 'serious' criteria? | No;Yes | No;Yes | Alphanumeric |
No instructions available |
Clinical Data Interchange Standards Consortium (CDISC) (https://www.cdisc.org/kb/ecrf/adverse-events) | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:40 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C60378 | Serious adverse event other important medical event text | SerAdvrsEvntOthrImptMdcEvntTxt | The free-text field to describe the medically important event not covered by other 'serious' criteria | The free-text field to describe the medically important event not covered by other 'serious' criteria | If YES, specify | Alphanumeric |
No instructions available |
No references available | Adult;Pediatric | Supplemental | 1 | 10/16/2024 8:50:41 AM | Serious Adverse Events | Adverse Events | Safety Data | 4000 |
Free-Form Entry |
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| C18659 | Unexpected adverse event indicator | UnexpectAdvrsEvntInd | Indicator of whether the adverse event is unexpected | 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 | 1.1 | 10/16/2024 8:51:00 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C20402 | Study blind broken indicator | StdyBlindBrokInd | Indicator of whether the study blind was broken | Indicator of whether the study blind was broken | Was the study blind broken? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:48 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C20392 | Serious adverse event treatment description text | SerAdvrsEvntTxDescTxt | The free-text field that describes the interventions specific to the serious adverse event | The free-text field that describes the interventions specific to the serious adverse event | Record treatment for event or attach appropriate documentation | Alphanumeric |
Data to be filled in by site; record treatment for event or attach appropriate documentation |
Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:42 AM | Serious Adverse Events | Adverse Events | Safety Data | 4000 |
Free-Form Entry |
2630200 | |||||||||
| C20403 | Serious adverse event investigator assessment reason | SerAdvrsEvntInvAssessRsn | Reason in the opinion of the principal investigator that is attributed as the cause of the serious adverse event | Reason in the opinion of the principal investigator that is attributed as the cause of the serious adverse event | Principal Investigator's opinion of what caused the event | Study intervention;Concomitant medication, specify;Concurrent disorder, specify;Withdrawal of study intervention, specify;Other, specify | Study intervention;Concomitant medication, specify;Concurrent disorder, specify;Withdrawal of study intervention, specify;Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 4 | 10/16/2024 8:50:50 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| 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 | If YES, serious adverse event onset date? | Date or Date & Time |
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). |
Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:29 AM | Serious Adverse Events | Adverse Events | Safety Data |
Free-Form Entry |
2744993 | ||||||||||
| C20404 | Serious adverse event investigator assessment concurrent disorder specify text | SerAdvrsEvntInvAsmtCncrDsSpTxt | The free-text field to specify the concurrent disorder that might have caused the serious adverse event, in the opinion of the principal investigator | The free-text field to specify the concurrent disorder that might have caused the serious adverse event, in the opinion of the principal investigator | Concurrent disorder, specify | Alphanumeric | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:51 AM | Serious Adverse Events | Adverse Events | Safety Data | 2000 |
Free-Form Entry |
2630200 | ||||||||||
| 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 | If NO, resolution date | Date or Date & Time |
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). |
Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:32 AM | Serious Adverse Events | Adverse Events | Safety Data |
Free-Form Entry |
2189843 | ||||||||||
| C20405 | Serious adverse event anticipate indicator | SerAdvrsEvntAnticInd | Indicator of whether the serious adverse event was anticipated | Indicator of whether the serious adverse event was anticipated | Was this type of event anticipated in the protocol and consent form? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.1 | 10/16/2024 8:50:53 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C20395 | Serious adverse event laboratory data text | SerAdvrsEvntLabDataTxt | The free-text field that describes the relevant tests or laboratory data specific to the serious adverse event | The free-text field that describes the relevant tests or laboratory data specific to the serious adverse event | Record relevant tests or laboratory data, including dates or attach the appropriate documentation | Alphanumeric |
Data to be filled in by site; record relevant tests or laboratory data, including dates or attach the appropriate documentation. See General CDE Data Standards Laboratory Tests and Tracking CRF Module |
Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:42 AM | Serious Adverse Events | Adverse Events | Safety Data | 4000 |
Free-Form Entry |
2630200 | |||||||||
| C20406 | Serious adverse event comment text | SerAdvrsEvntCmntTxt | The free-text field to provide any additional information that pertains to the serious adverse event | The free-text field to provide any additional information that pertains to the serious adverse event | Comments | Alphanumeric | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:51:01 AM | Serious Adverse Events | Adverse Events | Safety Data | 255 |
Free-Form Entry |
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| C20396 | Serious adverse event concomitant medication text | SerAdvrsEvntConcomMedTxt | The free-text field that describes the concomitant medications taken specific to the serious adverse event | The free-text field that describes the concomitant medications taken specific to the serious adverse event | Record concomitant medications or attach the appropriate Case Report Form (CRF) page(s) | Alphanumeric |
Data to be filled in by site; record concomitant medications or attach the appropriate Case Report Form (CRF) page(s). See General CDE Data Standards Prior and Concomitant Medications CRF Module |
Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:43 AM | Serious Adverse Events | Adverse Events | Safety Data | 2000 |
Free-Form Entry |
2630200 | |||||||||
| C20407 | Adverse event report identifier name | AdvrsEvntRepIdName | Name of an authorized group or person reporting the adverse event | Name of an authorized group or person reporting the adverse event | Reporter name and telephone number | Alphanumeric |
Please specify |
Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:55 AM | Serious Adverse Events | Adverse Events | Safety Data | 255 |
Free-Form Entry |
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| C20397 | Serious adverse event relevant history text | SerAdvrsEvntRelHisTxt | The free-text field that describes relevant history including pre-existing medical conditions specific to the serious adverse event | The free-text field that describes relevant history including pre-existing medical conditions specific to the serious adverse event | Record relevant history including pre-existing medical conditions or attach appropriate CRF pages(s) | Alphanumeric |
Data to be filled in by site; record medical history including pre-existing medical conditions or attach appropriate CRF page(s). See General CDE Data Standards Medical History CRF Module |
Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:44 AM | Serious Adverse Events | Adverse Events | Safety Data | 4000 |
Free-Form Entry |
2630200 | |||||||||
| C20408 | Serious adverse event report type | SerAdvrsEvntRepTyp | Type of report being completed for the serious adverse event | Type of report being completed for the serious adverse event | Type of report | Final report;Follow-up report;Initial report | Final report;Follow-up report;Initial report | Alphanumeric | Adult;Pediatric | Supplemental | 1.1 | 10/16/2024 8:50:57 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| 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 |
Text may be prepopulated from Adverse Events CRF. 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 separately. 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 | Serious Adverse Events | Adverse Events | Safety Data | 4000 |
Free-Form Entry |
2188132 | ||||||||
| C20398 | Serious adverse event study intervention administration text | SerAdvrsEvntStdyIntrvntAdmTxt | 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 | 3.1 | 10/16/2024 8:50:45 AM | Serious Adverse Events | Adverse Events | Safety Data | 4000 |
Free-Form Entry |
2630200 | ||||||||||
| C20409 | Adverse event sponsor attribution indicator | AdvrsEvntSpnsrAttrInd | Indicator of whether the adverse event was caused by the study intervention in question, based on the sponsor's assessment | Indicator of whether the adverse event was caused by the study intervention in question, based on the sponsor's assessment | Based on the sponsor's assessment, is there at least a reasonable possibility that the adverse event was caused by use of the study intervention? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 2 | 10/16/2024 8:51:00 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C02309 | Serious adverse event indicator | SeriousAdvrsEvntInd | Indicator of whether the adverse event is serious | Indicator of whether the adverse event is serious | Is the adverse event serious? | Yes;No | Yes;No | Alphanumeric |
Choose either Yes or 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; or 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 the Serious Adverse Event (SAE) form. Additionally, the site institution and/or IRB may also have an SAE form and procedures for reporting SAEs. If NO, do not complete the rest of the form. |
Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:29 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
2199908 | ||||||||
| C20399 | Serious adverse event end study intervention indicator | SerAdvrsEvntEndStdyIntrvntInd | Indicator of whether the study intervention was discontinued due to the serious adverse event | Indicator of whether the study intervention was discontinued due to the serious adverse event | Was study intervention discontinued due to the event? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:46 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C20413 | Serious adverse event investigator assessment concomitant medication specify text | SerAdvrsEvntInvAsmtCncmMdSpTxt | The free-text field to specify the concomitant medication that might have caused the serious adverse event, in the opinion of the principal investigator | The free-text field to specify the concomitant medication that might have caused the serious adverse event, in the opinion of the principal investigator | Concomitant medication, specify | Alphanumeric | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:50 AM | Serious Adverse Events | Adverse Events | Safety Data | 2000 |
Free-Form Entry |
2630200 | ||||||||||
| 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 | Serious Adverse Events | Adverse Events | Safety Data | 255 |
Free-Form Entry |
3125302 | ||||||||
| C20400 | Serious adverse event resolve end study intervention indicator | SerAdvrsEvntResolEndStdyIntInd | Indicator of whether a serious adverse event ended after the study intervention was stopped | Indicator of whether a serious adverse event ended after the study intervention was stopped | Was the seriousness of the event abated after discontinuation of the study intervention? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:47 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C20414 | Serious adverse event investigator assessment intervention withdrawal specify text | SerAdvrsEvntInvAsmtIntWdlSpTxt | The free-text field to specify the details of the withdrawal of study intervention that might have caused the serious adverse event, in the opinion of the principal investigator | The free-text field to specify the details of the withdrawal of study intervention that might have caused the serious adverse event, in the opinion of the principal investigator | Withdrawal of study intervention, specify | Alphanumeric | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:52 AM | Serious Adverse Events | Adverse Events | Safety Data | 4000 |
Free-Form Entry |
2630200 | ||||||||||
| 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 | Serious Adverse Events | Adverse Events | Safety Data | 255 |
Free-Form Entry |
3133353 | ||||||||
| C20401 | Serious adverse event reappearance restart study intervention indicator | SerAdvrsEvntReappRstStdyIntInd | Indicator of whether the adverse event reappeared after the study intervention was restarted | Indicator of whether the adverse event reappeared after the study intervention was restarted | Did event reappear after reintroduction of the study intervention? | Yes;No;N/A | Yes;No;N/A | Alphanumeric | Adult;Pediatric | Supplemental | 3.1 | 10/16/2024 8:50:47 AM | Serious Adverse Events | Adverse Events | Safety Data |
Single Pre-Defined Value Selected |
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| C20415 | Serious adverse event report complete date | SerAdvrsEvntRprtCompDate | Date when the report on the serious adverse event was completed | Date when the report on the serious adverse event was completed | Date report completed | Date or Date & Time |
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 should be recorded to the level of granularity known (e.g., year, year and month, complete date) 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). |
Adult;Pediatric | Supplemental | 1.1 | 10/16/2024 8:50:58 AM | Serious Adverse Events | Adverse Events | Safety Data |
Free-Form Entry |
