Diabetic Ketoacidosis Adverse Events

Illustrates Domains

AE
FA

Illustrates Variables

AEOCCUR
AESSEVCN
AECONTRT
AESHOSP
AESINTV
AEANYDEV
FAORRES
FAAENO

Content

In this study, the sponsor included a regular study AE CRF and a DKA AE CRF. This DKA AE CRF collects information about a subject's DKA event. This CRF includes information on the relationship to any devices the subject is using and the actions taken with those devices. If the same information is collected for multiple devices, this would typically be displayed to investigators as repeating fields in a tabular format. However, this format is not shown below; instead, variables using the notation (n) represent the data that would be displayed by an EDC system as a table using repeating fields.

Because cerebral edema is associated with DKA events in children, the sponsor collected information on whether this event occurred. If this event occurred, the sponsor reported this event on the regular study AE CRF (not shown).

This DKA AE CRF includes the CDASH variable FAAENO. This variable was used by the sponsor to assign/derive the appropriate timing variables associated with the use of the SDTM Trial and SM domains. These mapping instructions are not provided.

Title: On-study DKA Event

CRF Completion Instructions

Record all DKA events on this DKA AE CRF after informed consent is obtained. Other AEs should be reported on the regular study AE form.
All serious adverse events (AEs), regardless of relationship to study drug, must be reported via telephone or fax within 24 hours of discovery.
Safety information (e.g., AE, SAE) identified for all subjects must be recorded on source documents from the time informed consent is obtained.

Indicate whether or not diabetic ketoacidosis (DKA) occurred. Each episode should be listed as a separate event.	Did the subject have (confirmed) diabetic ketoacidosis? DKA_AEOCCUR Not Submitted or FAORRES=the value of AEOCCUR where FATESTCD="OCCUR"	Yes No
If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.	AE Number AESPID	_________________
	Adverse Event AETERM Hidden/pre-populated	Diabetic ketoacidosis
	MIDS Hidden/pre-populated	Sponsor-defined
	AEPRESP Hidden/pre-populated	Y
Record start date using this format (DD-MMM-YYYY).	What is the start date of the DKA event? AESTDAT AESTDTC MIDSDTC	_________________
Indicate whether confirmatory laboratory results were available. If Yes, complete the appropriate sections of the DKA Laboratory CRF.	Were confirmatory laboratory results available for this DKA event? LBYN Not submitted	Yes No
Indicate whether the subject was actively using any diabetic devices at the time of the event. If Yes, complete the appropriate sections of the DKA Device CRF.	Was the subject actively using any diabetes-related devices at the time of the event? DXYN Not submitted	Yes No
Indicate whether signs and symptoms were present. If Yes, complete the DKA Signs/Symptoms and Precipitating Factors CRF.	Were signs/symptoms present? CEYN Not submitted	Yes No
Indicate whether any precipitating factors were present. If Yes, complete the DKA Signs/Symptoms and Precipitating Factors CRF.	Were there any precipitating factors reported? PFACTOR_FAYN Not submitted	Yes No
Indicate whether any non-study drug treatments were given. If Yes, complete the Concomitant Medication CRF.	Were any non-study drug treatments given for the DKA event? AECONTRT	Yes No
Indicate the criteria used to assess the DKA severity.	Which criteria were used to define the severity of the DKA event? NSV_AESSEVCN NSAE.AESSEVCN	ADA Version x ISPAD Version x Unknown
Indicate the severity of the DKA event.	What was the severity of the DKA event? NSV_AESTDSEV NSAE.AESTDSEV	MILD MODERATE SEVERE
Assess whether the adverse event should be classified as serious based on the criteria defined in the protocol.	Was the adverse event serious? AESER	Yes No
Record whether the serious adverse event resulted in an initial or prolonged hospitalization.	Did the adverse event result in initial or prolonged hospitalization for the subject? AESHOSP	Yes No
Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.	Did the adverse event require intervention to prevent permanent impairment or damage resulting from the use of a medical product? AESINTV NSAE.AESINTV	Yes No
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).	Was this adverse event related to study treatment? AEREL	NOT RELATED UNLIKELY RELATED POSSIBLY RELATED RELATED
Record changes made to the study treatment resulting from the adverse event.	What action was taken with study treatment? AEACN	DRUG WITHDRAWN DOSE REDUCED DOSE INCREASED DOSE NOT CHANGED UNKNOWN NOT APPLICABLE
Record the appropriate outcome of the event in relation to the subject's status. Record any sequelae as a separate event.	What was the outcome of this adverse event? AEOUT	RECOVERING / RESOLVING NOT RECOVERED / NOT RESOLVED RECOVERED / RESOLVED RECOVERED / RESOLVED WITH SEQUELAE FATAL
Record whether the subject experienced cerebral edema . If Yes, record the event on the regular study AE form.	Did the subject have cerebral edema associated with this DKA event? FAOCCUR FAORRES where FAOBJ="Cerebral edema" and FATESTCD="OCCUR".	Yes No
Record the identifier for the reported cerebral edema event.	What is the identifier for the adverse event associated with cerebral edema? FAAENO Not submitted	_________________
Select No if there was no relationship and no action taken with any device. If Yes, complete the following questions for each evaluated device.	Was there a relationship, or action taken, with any device? AEANYDEV NSAE.AERLDEV AEACNDEV	Yes No
Select the device being evaluated for relationship and the action taken with respect to this adverse event.	Which device was evaluated with respect to this adverse event? CSPDEVID(n) SPDEVID	Real-Time Continuous Glucose Monitor Flash Glucose Monitor Glucose Meter Glucose/Ketones Meter Ketones Meter Insulin Inhaler Electronic Insulin Pump Mechanical Insulin Pump Automated Insulin Delivery System
Record the relationship of the adverse event to each study or non-study device used in the study. Record 1 relationship per line.	Was this adverse event related to the specified device? AERLDEV(n) NSAE.AERLDEV or FAORRES where FATESTCD = "RLDEV" and FAOBJ= "Diabetic ketoacidosis"	NOT RELATED UNLIKELY RELATED POSSIBLY RELATED RELATED
Record the action taken resulting from the adverse event that are related to a study or non-study device. Record 1 device action taken per line.	What action was taken with the specified device? AEACNDEV(n) AEACNDEV or FAORRES where FATESTCD = "ACNDEV" and FAOBJ= "Diabetic ketoacidosis"	_________________

View CRF Metadata

Order Number	TAUG Reference	CDASHIG Variable	Question Text	Prompt	Data Type	Case Report Form Completion Instructions	SDTMIG Target	SDTMIG Variable Mapping	CRF Implementation Notes	Permissible Values	Pre-specified Value	Query Display	List Style	Hidden
1	TAUG-T1D-P&D	DKA_AEOCCUR	Did the subject have (confirmed) diabetic ketoacidosis?	Adverse Event Occurrence	text	Indicate whether or not diabetic ketoacidosis (DKA) occurred. Each episode should be listed as a separate event.		Not Submitted or FAORRES=the value of AEOCCUR where FATESTCD="OCCUR"	Primary intent/purpose of field is to help with data cleaning and monitoring. May be represented in an FAAE domain. Where AEOCCUR="Y", there should be a corresponding record in the AE domain, with the event of interest..	Yes; No;
2	TAUG-T1D-P&D	AESPID	What is the adverse event identifier?	AE Number	text	If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier.	AESPID					prompt
3	TAUG-T1D-P&D	AETERM	Adverse Event Reported Term	Adverse Event	text	Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise, enter a sign or symptom.	AETERM				Diabetic ketoacidosis			Y
4	TAUG-T1D-P&D	MIDS	N/A	N/A	text		MIDS		Sponsor derived name of the event (e.g., DKA01, DKA-02. May be determined from AESPID.		Sponsor-defined			Y
5	TAUG-T1D-P&D	AEPRESP	N/A	N/A	text	N/A	AEPRESP		A hidden field on a CRF defaulted to Y, or added during the SDTM-based dataset creation,		Y			Y
6	TAUG-T1D-P&D	AESTDAT	What is the start date of the DKA event?	Start Date	text	Record start date using this format (DD-MMM-YYYY).	AESTDTC; MIDSDTC		This CRF assumes that a DKA trial milestone is defined. In this situation, MIDSTDTC is defined as the start date of the DKA event.
7	TAUG-T1D-P&D	LBYN	Were confirmatory laboratory results available for this DKA event?	Performed	text	Indicate whether confirmatory laboratory results were available. If Yes, complete the appropriate sections of the DKA Laboratory CRF.			Primary intent/purpose of field is to help with data cleaning and monitoring. This field is used to navigate to other CRF modules.	Yes;No;
8	TAUG-T1D-P&D	DXYN	Was the subject actively using any diabetes-related devices at the time of the event?	Any Diabetic Devices in Use	text	Indicate whether the subject was actively using any diabetic devices at the time of the event. If Yes, complete the appropriate sections of the DKA Device CRF.			Primary intent/purpose of field is to help with data cleaning and monitoring. This field is used to navigate to other CRF modules.	Yes;No			radio
9	TAUG-T1D-P&D	CEYN	Were signs/symptoms present?		text	Indicate whether signs and symptoms were present. If Yes, complete the DKA Signs/Symptoms and Precipitating Factors CRF.			Primary intent/purpose of field is to help with data cleaning and monitoring. This field is used to navigate to other CRF modules.	Yes; No
10	TAUG-T1D-P&D	PFACTOR_FAYN	Were there any precipitating factors reported?		text	Indicate whether any precipitating factors were present. If Yes, complete the DKA Signs/Symptoms and Precipitating Factors CRF.			Primary intent/purpose of field is to help with data cleaning and monitoring. This field is used to navigate to other CRF modules.	Yes; No
11	TAUG-T1D-P&D	AECONTRT	Were any non-study drug treatments given for the DKA event?	Concomitant or Additional Trtmnt Given	text	Indicate whether any non-study drug treatments were given. If Yes, complete the Concomitant Medication CRF.	AECONTRT			Yes; No
12	TAUG-T1D-P&D	NSV_AESSEVCN	Which criteria were used to define the severity of the DKA event?	Standardized Severity Criteria Name	text	Indicate the criteria used to assess the DKA severity.	NSAE.AESSEVCN			ADA Version x; ISPAD Version x; Unknown;
13	TAUG-T1D-P&D	NSV_AESTDSEV	What was the severity of the DKA event?	Standardized Severity/intensity	text	Indicate the severity of the DKA event.	NSAE.AESTDSEV			MILD; MODERATE; SEVERE
14	TAUG-T1D-P&D	AESER	Was the adverse event serious?	Adverse Event Serious Event	text	Assess whether the adverse event should be classified as serious based on the criteria defined in the protocol.	AESER			Yes;No;
15	TAUG-T1D-P&D	AESHOSP	Did the adverse event result in initial or prolonged hospitalization for the subject?	Initial or Prolonged Hospitalization	text	Record whether the serious adverse event resulted in an initial or prolonged hospitalization.	AESHOSP			Yes;No
16	TAUG-T1D-P&D	AESINTV	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	text	Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product.	NSAE.AESINTV			Yes;No
17	TAUG-T1D-P&D	AEREL	Was this adverse event related to study treatment?	Adverse Event Causality	text	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).	AEREL		Other possible responses may be used. However, Controlled Terminology may be defined in the future	NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED
18	TAUG-T1D-P&D	AEACN	What action was taken with study treatment?	Action Taken with Study Treatment	text	Record changes made to the study treatment resulting from the adverse event.	AEACN			DRUG WITHDRAWN; DOSE REDUCED; DOSE INCREASED; DOSE NOT CHANGED; UNKNOWN; NOT APPLICABLE
19	TAUG-T1D-P&D	AEOUT	What was the outcome of this adverse event?	Outcome of Adverse Event	text	Record the appropriate outcome of the event in relation to the subject's status. Record any sequelae as a separate event.	AEOUT			RECOVERING / RESOLVING; NOT RECOVERED / NOT RESOLVED; RECOVERED / RESOLVED; RECOVERED / RESOLVED WITH SEQUELAE; FATAL
20	TAUG-T1D-P&D	FAOCCUR	Did the subject have cerebral edema associated with this DKA event?	FAOCCUR	text	Record whether the subject experienced cerebral edema . If Yes, record the event on the regular study AE form.	FAORRES	FAORRES where FAOBJ="Cerebral edema" and FATESTCD="OCCUR".	In this example, the sponsor, submitted this item. When FAOCCUR="Y", there should be a corresponding record in the AE domain,with the event of interest..	Yes;No
21	TAUG-T1D-P&D	FAAENO	What is the identifier for the adverse event associated with cerebral edema?	FAAENO	text	Record the identifier for the reported cerebral edema event.			The sponsor may use this identifier to assign the value of MIDS to the AE record created for cerebral edema. When, MIDS are used, RELREC may not be needed.
22	TAUG-T1D-P&D	AEANYDEV	Was there a relationship, or action taken, with any device?		text	Select No if there was no relationship and no action taken with <i>any device</i>. <br/>If Yes, complete the following questions for each evaluated device.	NSAE.AERLDEV;AEACNDEV		If "No", then AEACNDEV = "NONE" and NSAE.AERLDEV = "NOT RELATED". If "Yes" and multiple devices evaluated, then AEACNDEV = "MULTIPLE" and NSAE.AERLDEV = "MULTIPLE".	Yes;No			radio
23	TAUG-T1D-P&D	CSPDEVID(n)	Which device was evaluated with respect to this adverse event?	Collected Sponsor Device Identification	text	Select the device being evaluated for relationship and the action taken with respect to this adverse event.	SPDEVID		If a single device is evaluated, SPDEVID in AE is populated with the device identifier from DI, which corresponds with the selected device. If multiple devices are evaluated, then then each evaluation (relationship/action taken) records are created in FA for each device evaluation and SPDEVID in FA is populated with the device identifier from DI, which corresponds with the selected device.	Real-Time Continuous Glucose Monitor; Flash Glucose Monitor; Glucose Meter; Glucose/Ketones Meter; Ketones Meter; Insulin Inhaler; Electronic Insulin Pump; Mechanical Insulin Pump; Automated Insulin Delivery System			radio
24	TAUG-T1D-P&D	AERLDEV(n)	Was this adverse event related to the specified device?	Adverse Event Relationship to Device	text	Record the relationship of the adverse event to each study or non-study device used in the study. Record 1 relationship per line.	NSAE.AERLDEV;FAORRES	NSAE.AERLDEV or FAORRES where FATESTCD = "RLDEV" and FAOBJ= "Diabetic ketoacidosis"	Other possible responses may be used. However, Controlled Terminology may be defined in the future. If a single device is evaluated, then the relationship maps to NSAE.AERLDEV. If relationships to multiple devices are collected, then, then each relationship is associated with the appropriate device identifier, and lines are created in FA for each device.	NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED
25	TAUG-T1D-P&D	AEACNDEV(n)	What action was taken with the specified device?	Actions Taken with Device	text	Record the action taken resulting from the adverse event that are related to a study or non-study device. Record 1 device action taken per line.	AEACNDEV;FAORRES	AEACNDEV or FAORRES where FATESTCD = "ACNDEV" and FAOBJ= "Diabetic ketoacidosis"	If a single device is evaluated, then the action take maps to AEACNDEV. If actions are taken with multiple devices, then each action is associated with the appropriate device identifier, and lines are created in FA for each device where an action was taken.