CDE Detailed Report

Disease: General (For all diseases)
Subdomain Name: Adverse Events
CRF: Serious Adverse Events

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
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CSV