CDE Detailed Report
Subdomain Name: History of Disease/Injury Event
CRF: Relapse
Displaying 1 - 14 of 14
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
