CDE Detailed Report | NINDS Common Data Elements

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Subdomain Name: History of Disease/Injury Event
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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
C58716	Specific system relapse type	SpecSysRelapseTyp	The specific system(s) involved in the relapse	The specific system(s) involved in the relapse	If Yes, was the [specify system] system involved in the relapse? (Choose all that apply)	Mental;Visual;Ambulation;Pyramidal;Sensory;Cerebellar;Bowel and/or Bladder	Mental;Visual;Ambulation;Pyramidal;Sensory;Cerebellar;Bowel and/or Bladder	Alphanumeric			Adult;Pediatric	Supplemental	1.00	2020-05-06 17:41:26.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Multiple Pre-Defined Values Selected
C16103	Fever due to intercurrent illness indicator	FeverIntrcrntIllnessInd	Indicates whether the participant/subject has fever due to intercurrent illness	Indicates whether the participant/subject has fever due to intercurrent illness	Did the participant/subject have a fever due to intercurrent illness	Yes;No	Yes;No	Alphanumeric	If 'Yes' is answered, skip to question 7	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C16104	MS symptoms stable or improving indicator	MSSympsStblImprvngInd	Indicates whether prior to the onset of this event, the participant's/subject's Multiple Sclerosis (MS) symptoms were stable or improving over the last 30 days	Indicates whether prior to the onset of this event, the participant's/subject's MS symptoms were stable or improving over the last 30 days	Prior to the onset of this event, were the participant's/subject's MS symptom(s) stable or improving over the last 30 days	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	No additional instructions	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C16105	MS relapse onset within the last 24 hours indicator	MSRlpse24HrsInd	Indicates whether onset of relapse was within the last 24 hours	Indicates whether onset of relapse was within the last 24 hours	Was onset within the last 24 hours	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	Only answered if "Yes" was answered for "Prior to the onset of this event, were the participant's/subject's MS symptom(s) stable or improving over the last 30 days?"	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C16106	MS relapse onset within the last 7 days indicator	MSRlpse7DaysInd	Indicates whether onset of relapse was within the last 7 days	Indicates whether onset of relapse was within the last 7 days	Was the onset within the last 7 days	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	Only answered if "No" was answered for "Prior to the onset of this event, were the participant's/subject's MS symptom(s) stable or improving over the last 30 days?"	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C16107	Symptom associated with new neurologic findings indicator	SymptmAssocNewNeuroIFindnd	Indicates whether the symptom(s) are associated with new neurologic findings	Indicates whether the symptom(s) are associated with new neurologic findings	Are the symptom(s) associated with new neurologic findings	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	No additional instructions	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C16109	System deficit type indicator	SysDefecitTypInd	Indicates whether the symptom(s)/deficit was present in the system	Indicates whether the symptom(s)/deficit was present in the system	In which system(s) was/is the deficit present	Yes;No	Yes;No	Alphanumeric	Answer for all system(s).	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C16110	Symptom associated with new neurologic findings ongoing indicator	SymptmAssocNeuroFind	Indicates whether the symptom(s) associated with new neurologic findings are ongoing	Indicates whether the symptom(s) associated with new neurologic findings are ongoing	Are the participant's/subject's symtom(s) ongoing	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	No additional instructions	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C16116	Symptom end date	SymptmEndDate	The last or final date (and time, if applicable and known) when a symptom was present	Last or final date (and time, if known) of a symptom(s)	End Date			Date or Date & Time	Only answered if "No" was answered for "Are the participant's/subject's symptom(s) ongoing?" Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/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.).	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Free-Form Entry
C05404	Symptom onset date and time	SymptmOnsetDateTime	Date (and time, if applicable and known) reported for onset of participant's/subject's symptoms	Date (and time, if applicable and known) reported for onset of participant's/subject's symptoms	Date of onset			Date or Date & Time	Symptoms Onset Date – Record the date of relapse onset to the level of certainty available (mm/dd/yyyy). Onset is the time of onset at which the patient initially reports the new neurological symptom consistent with MS or worsening/recurrence of prior MS symptoms Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/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.). Symptom is referring to dysphasia, dysarthria, focal weakness, shortness of breath, gait disturbance. Symptom does NOT refer to cramps, fatigue or fasciculati The time of symptom discovery is either the time at which the patient was first noted by another person to have stroke symptoms or the self-reported time by an individual who may not be accurate or reliable in their assessment of stroke symptoms onset (e.g., in the setting of neglect or anosagnosia, or aphasia). When the event is witnessed by another person, then the time of discovery is identical to the time of last known well; however, when unwitnessed or self-reported by an unreliable patient, this time of discovery will be later chronologically than the time last known well. For Multiple Sclerosis studies, it is sufficient to just record the month and year of first symptoms in the format MM/YYYY.	Get With The Guidelines (GWTG) Stroke Patient Management Tool Coding Instructions (Updated on 11/4/2009); Paul Coverdell National Acute Stroke Registry	Adult;Pediatric	Supplemental	3.00	2013-07-25 08:54:08.2	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Free-Form Entry
C16117	Protocol defined qualifying relapse indicator	ProtclQualfRlpseInd	If applicable, is this a protocol defined qualifying relapse according to the definition set in the study protocol	If applicable, is this a protocol defined qualifying relapse according to the definition set in the study protocol	Is this a protocol defined qualifying relapse according to the definition set in the study protocol	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	No additional instructions	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C16100	Symptoms new or worsening neurologic indicator	SymptmNewWrseNeuroInd	Indicates whether the participant/subject has new neurologic symptoms or an acute worsening of preexisting neurologic symptoms	Indicates whether the participant/subject has new neurologic symptoms or an acute worsening of preexisting neurologic symptoms	Is the participant/subject having new neurologic symptom(s) or an acute worsening of preexisting neurologic symptoms	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	If 'No' is answered, stop form	No references available	Adult;Pediatric	Supplemental-Highly Recommended	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected
C17447	Event description text	EvntDescrTxt	The free-text field to describe the event	The free-text field to describe the even	Please describe event, symptom(s) and treatment that occurred with the participant/subject			Alphanumeric		No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events	255	Free-Form Entry
C16102	Symptom new or worsening greater than 24 hours indicator	SymptmGreater24HrsInd	Indicates whether any new or worsening symptoms have occurred lasting more than 24 hours that may signal a new episode or progression of multiple sclerosis	Indicates whether any new or worsening symptoms have occurred that may signal a new episode or progression of multiple sclerosis	Did the symptoms last more than 24 hours	Yes;No;Unknown	Yes;No;Unknown	Alphanumeric	If 'No' is answered, skip to question 7	No references available	Adult;Pediatric	Supplemental	3.00	2013-06-11 00:00:00.0	Relapse	History of Disease/Injury Event	Disease/Injury Related Events		Single Pre-Defined Value Selected