CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: History of Disease/Injury Event
CRF: Relapse

Displaying 1 - 14 of 14
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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

C16108 System deficit type SysDefecitTyp The system(s) where the symptom(s) were discovered The system(s) where the symptom(s) were discovered In which system(s) was/is the deficit present Pyramidal;Sensory;Cerebellar;Bowel and/or Bladder;Brainstem;Mental;Visual Pyramidal;Sensory;Cerebellar;Bowel and/or Bladder;Brainstem;Mental;Visual Alphanumeric

Choose all that apply

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

Multiple Pre-Defined Values 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

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

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

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

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 3.00 2013-06-11 00:00:00.0 Relapse History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

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

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 8

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

C17447 Event description text EvntDescrTxt The free-text field to describe the event. The free-text field to describe the event. 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

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 8

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

CSV