Adverse experiences Example 1

The AE domain includes clinical data describing "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment" (ICH E2A). In consultation with regulatory authorities, sponsors may extend or limit the scope of adverse event collection (e.g., collecting pre-treatment events related to trial conduct, not collecting events that are assessed as efficacy endpoints). Events included in the AE domain should be consistent with protocol requirements. Adverse event terms may be captured either as free text or via a prespecified list of terms.

Outstanding Issues

The standard SDTM uses the term study treatment for several variables ( AEREL, AEACN. Should this be changes to study product (or another term).

This is an example of a CRF used to collect all adverse experiences that occurred after informed consent is obtained. Adverse experiences were collect using free-text.

Indicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF.	Were any adverse events experienced? AEYN Not Submitted	Yes No <NY codelist>
	Adverse Event Category AECAT Hidden/pre-populated	Sponsor Defined
	Adverse Event Subcategory AESCAT Hidden/pre-populated	Sponsor Defined
If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.	AE Number AESPID	_______
Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise, enter a sign or symptom.	What is the adverse event term? AETERM	_________________
Record the start date of the AE using this format (DD-MON-YYYY).	Start Date AESTDAT AESTDTC	_ _ / _ _ _ / _ _ _ _
Indicate if the adverse event has not resolved at the time of data collection; leave the End Date blank.	Is the adverse event ongoing? AEONGO AEENRTPT AEENRF	Yes <NY codelist>
Record the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.	End Date AEENDAT AEENDTC	_ _ / _ _ _ / _ _ _ _
The reporting physician/healthcare professional will assess the severity of the event using sponsor-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported AE to similar type events observed in clinical practice. Severity is not equivalent to seriousness.	Severity AESEV	MILD MODERATE SEVERE <AESEV codelist>
Assess if an adverse event should be classified as serious based on the criteria defined in the protocol.	Was the adverse event serious? AESER	Yes No <NY codelist>
Record whether the serious adverse event resulted in death.	Did the adverse event result in death? AESDTH	Yes No <NY codelist>
Record the date of death.	Death Date DTHDAT DM.DTHDTC	_ _ / _ _ _ / _ _ _ _
Record whether the serious adverse event is life-threatening.	Life Threatening AESLIFE	Yes No <NY codelist>
Record whether the serious adverse event resulted in an initial or prolonged hospitalization.	Hospitalization (initial or prolonged) AESHOSP	Yes No <NY codelist>
Record whether the serious adverse event resulted in a persistent or significant disability or incapacity.	Disability or Permanent Damage AESDISAB	Yes No <NY codelist>
Record whether the serious adverse event was associated with congenital anomaly or birth defect.	Congenital Anomaly or Birth Defect AESCONG	Yes No <NY codelist>
Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.	Needs Intervention to Prevent Impairment AESINTV SUPPAE.QVAL	Yes No <NY codelist>
Record whether the serious adverse event is an important medical event, which may be defined in the protocol or in the investigator brochure.	Other Serious (Important Medical Events) AESMIE	Yes No <NY codelist>
Indicate if the cause of the adverse event was related to the study treatment and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions).	Relationship to Study Treatment AEREL	NOT RELATED UNLIKELY RELATED POSSIBLY RELATED RELATED
Record changes made to the study treatment resulting from the adverse event.	Action Taken with Study Treatment AEACN	DRUG WITHDRAWN DOSE REDUCED DOSE INCREASED DOSE NOT CHANGED UNKNOWN NOT APPLICABLE <ACN codelist>
Record the appropriate outcome of the event in relation to the subject's status.	Outcome AEOUT	RECOVERING / RESOLVING NOT RECOVERED / NOT RESOLVED RECOVERED / RESOLVED RECOVERED / RESOLVED WITH SEQUELAE FATAL <OUT codelist>

Order	Question Text	Prompt	CRF Completion Instructions	Type	CDASH Variable	SDTMIG Target Variable	SDTMIG Target Mapping	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value	Query Display	List Style	Hidden
1	Were any adverse events experienced?	Any Adverse Events	Indicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF.	Text	AEYN	N/A		(NY)	Yes; No
2	What is the category of the adverse event?	Adverse Event Category	Record the adverse event category, if not pre-printed on the CRF.	Text	AECAT	AECAT				Sponsor Defined			Yes
3	What is the subcategory of the adverse event?	Adverse Event Subcategory	Record the adverse event subcategory, if not pre-printed on the CRF.	Text	AESCAT	AESCAT				Sponsor Defined			Yes
4	What is the adverse event identifier?	AE Number	If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.	Integer	AESPID	AESPID					prompt
5	What is the adverse event term?	Adverse Event	Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise, enter a sign or symptom.	Text	AETERM	AETERM
6	What is the adverse event start date?	Start Date	Record the start date of the AE using this format (DD-MON-YYYY).	Date	AESTDAT	AESTDTC					prompt
7	Is the adverse event ongoing?	Ongoing	Indicate if the adverse event has not resolved at the time of data collection; leave the End Date blank.	Text	AEONGO	AEENRTPT; AEENRF	AEENRTPT; AEENRF	(NY)	Yes			checkbox
8	What was the adverse event end date?	End Date	Record the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.	date	AEENDAT	AEENDTC					prompt
9	What is the severity of the adverse event?	Severity	The reporting physician/healthcare professional will assess the severity of the event using sponsor-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported AE to similar type events observed in clinical practice. Severity is not equivalent to seriousness.	Text	AESEV	AESEV		(AESEV)	MILD; MODERATE; SEVERE		prompt
10	Was the adverse event serious?	Serious	Assess if an adverse event should be classified as serious based on the criteria defined in the protocol.	Text	AESER	AESER		(NY)	Yes; No
11	Did the adverse event result in death?	Death	Record whether the serious adverse event resulted in death.	Text	AESDTH	AESDTH		(NY)	Yes; No
12	What [is/was] the subject’s date of death?	Death Date	Record the date of death.	date	DTHDAT	DM.DTHDTC					prompt
13	Was the adverse event life-threatening?	Life Threatening	Record whether the serious adverse event is life-threatening.	Text	AESLIFE	AESLIFE		(NY)	Yes; No		prompt
14	Did the adverse event result in initial or prolonged hospitalization for the subject?	Hospitalization (initial or prolonged)	Record whether the serious adverse event resulted in an initial or prolonged hospitalization.	Text	AESHOSP	AESHOSP		(NY)	Yes; No		prompt
15	Did the adverse event result in disability or permanent damage?	Disability or Permanent Damage	Record whether the serious adverse event resulted in a persistent or significant disability or incapacity.	Text	AESDISAB	AESDISAB		(NY)	Yes; No		prompt
16	Was the adverse event associated with a congenital anomaly or birth defect?	Congenital Anomaly or Birth Defect	Record whether the serious adverse event was associated with congenital anomaly or birth defect.	Text	AESCONG	AESCONG		(NY)	Yes; No		prompt
17	Did the adverse event require intervention to prevent permanent impairment or damage resulting from the use of a medical product?	Needs Intervention to Prevent Impairment	Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.	Text	AESINTV	SUPPAE.QVAL		(NY)	Yes; No		prompt
18	Was the adverse event a medically important event not covered by other "serious" criteria?	Other Serious (Important Medical Events)	Record whether the serious adverse event is an important medical event, which may be defined in the protocol or in the investigator brochure.	Text	AESMIE	AESMIE		(NY)	Yes; No		prompt
19	Was this adverse event related to study treatment?	Relationship to Study Treatment	Indicate if the cause of the adverse event was related to the study treatment and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions).	Text	AEREL	AEREL			NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED		prompt
20	What action was taken with the study treatment?	Action Taken with Study Treatment	Record changes made to the study treatment resulting from the adverse event.	Text	AEACN	AEACN		(ACN)	DRUG WITHDRAWN; DOSE REDUCED; DOSE INCREASED; DOSE NOT CHANGED; UNKNOWN; NOT APPLICABLE		prompt
21	What is the outcome of this adverse event?	Outcome	Record the appropriate outcome of the event in relation to the subject's status.	Text	AEOUT	AEOUT		(OUT)	RECOVERING / RESOLVING; NOT RECOVERED / NOT RESOLVED; RECOVERED / RESOLVED; RECOVERED / RESOLVED WITH SEQUELAE; FATAL		prompt

This SDTM dataset illustrates data collected on the example AE CRF above, AEs were coded using MedDRA, and the sponsor’s procedures include the possibility of modifying the reported term to aid in coding. The CRF was structured so that seriousness category variables (e.g., AESDTH, AESHOSP) were checked only when AESER is answered “Y.” In this study, the study reference period started at the start of study treatment. Three AEs were reported for this subject.

Rows 1-2:

Show examples of modifying the reported term for coding purposes, with the modified term in AEMODIFY. These adverse events were not serious, so the seriousness criteria variables are null. Note that for the event in row 2, AESTDY = "1". Day 1 was the day treatment started; the AE start and end times, as well as dates, were collected to allow comparison of the AE timing to the start of treatment.

Row 3:

Shows an example of the overall seriousness question AESER answered with "Y" and the relevant corresponding seriousness category variables (AESHOSP and AESLIFE) answered "Y". The other seriousness category variables are left blank. This row also shows AEENRF being populated because the AE was marked as “Continuing” as of the end of the study reference period for the subject (see Section 4.4.7, Use of Relative Timing Variables).

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Row	STUDYID	DOMAIN	USUBJID	AESEQ	AETERM	AEMODIFY	AEDECOD	AEBODSYS	AESEV	AESER	AEACN	AEREL	AEOUT	AESHOSP	AESLIFE	EPOCH	AESTDTC	AEENDTC	AESTDY	AEENDY	AEENRF
1	ABC123	AE	123101	1	POUNDING HEADACHE	HEADACHE	Headache	Nervous system disorders	SEVERE	N	NOT APPLICABLE	DEFINITELY NOT RELATED	RECOVERED/RESOLVED			SCREENING	2005-10-12	2005-10-12	-1	-1
2	ABC123	AE	123101	2	BACK PAIN FOR 6 HOURS	BACK PAIN	Back pain	Musculoskeletal and connective tissue disorders	MODERATE	N	DOSE REDUCED	PROBABLY RELATED	RECOVERED/RESOLVED			TREATMENT	2005-10-13T13:05	2005-10-13T19:00	1	1
3	ABC123	AE	123101	3	PULMONARY EMBOLISM		Pulmonary embolism	Vascular disorders	MODERATE	Y	DOSE REDUCED	PROBABLY NOT RELATED	RECOVERING/RESOLVING	Y	Y	TREATMENT	2005-10-21		9		AFTER

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Adverse experiences Example 1