CDE Detailed Report

Disease: Amyotrophic Lateral Sclerosis
Subdomain Name: Classification
CRF: Symptom, Sign, Diagnosis Criteria

Displaying 1 - 25 of 25
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
C11125 Awaji criteria indicator AwajiCriteriaInd Awaji criteria for diagnosis of amyotrophic lateral sclerosis (ALS) category of diagnostic certainty or confidence Awaji criteria for diagnosis of amyotrophic lateral sclerosis (ALS) category of diagnostic certainty or confidenc Awaji Criteria Possible;Probable;Definite Possible;Probable;Definite Alphanumeric

Choose one

 No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17856 Right upper extremity lower motor neuron electromyogram indicator RUELMNEMGInd Indicator of whether an electromyogram (EMG) of the right upper extremity (RUE) region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different nerve roots Indicator of whether an electromyogram (EMG) of the right upper extremity (RUE) region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different n RUE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17817 Left lower extremity lower motor neuron electromyogram indicator LLELMNEMGInd Indicator of whether an electromyogram (EMG) of the left lower extremity (LLE) region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different nerve roots Indicator of whether an electromyogram (EMG) of the left lower extremity (LLE) region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different ne LLE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17857 Right upper extremity upper motor neuron clinical indicator RUEUMNClinInd Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the right upper extremity (RUE) region Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the right upper extremity (RUE) regio RUE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17818 Left lower extremity lower motor neuron clinical indicator LLELMNClinInd Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the left lower extremity (LLE) Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the left lower extremity (LLE LLE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17866 Trunk lower motor neuron clinical indicator TrunkLMNClinInd Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the trunk region Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the trunk regio Trunk Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification 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 Symptom 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 fasciculations.

 ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Free-Form Entry
C17819 Left lower extremity upper motor neuron clinical indicator LLEUMNClinInd Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the left lower extremity (LLE) region Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the left lower extremity (LLE) regio LLE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17867 Trunk lower motor neuron electromyogram indicator TrunkLMNEMGInd Indicator of whether an electromyogram (EMG) of the trunk region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different nerve roots Indicator of whether an electromyogram (EMG) of the trunk region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different nerve root Trunk Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C08007 Diagnosis first given date and time DiagnosFirstGivnDateTime Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder Diagnosis 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.).

 ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html) Adult;Pediatric Core 3.00 2013-07-24 11:38:01.2 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Free-Form Entry
C17820 Left upper extremity lower motor neuron clinical indicator LUELMNClinicalInd Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the left upper extremity (LUE) region Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the left upper extremity (LUE) regio LUE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17868 Trunk upper motor neuron clinical indicator TrunkUMNClinInd Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the trunk region Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the trunk regio Trunk Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C11119 Body part first affected text BodyPartFirstAffectedTxt Identification of the body part(s) first affected by the disease Identification of the body part(s) first affected by the diseas Body part first affected by the disease Bulbar;LUE;RUE;Trunk;LLE;RLE;Respiratory;Other, specify Bulbar;LUE (left upper extremity);RUE (right upper extremity);Trunk;LLE (left lower extremity);RLE (right lower extremity);Respiratory;Other, specify Alphanumeric

Select one. If more than one body part was first involved, then more than one may be selected.

 No references available Adult Core 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Multiple Pre-Defined Values Selected
C17821 Left upper extremity lower motor neuron electromyogram clinical indicator LUELMNEMGInd Indicator of whether an electromyogram (EMG) of the left upper extremity (LUE) region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and renovation in two muscles innovated by different peripheral nerve and different nerve roots Indicator of whether an electromyogram (EMG) of the left upper extremity (LUE) region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and renovation in two muscles innovated by different peripheral nerve and different nerve root LUE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C18823 Body part first affected other text BodyPartFirstAffectedOTH The free-text field related to 'Body part first affected text' specifying other text. Identification of the body part(s) first affected by the disease The free-text field related to 'Body part first affected text' specifying other text. Identification of the body part(s) first affected by the diseas Other, specify Alphanumeric

Select one. If more than one body part was first involved, then more than one may be selected.

 No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events 4000

Free-Form Entry
C11120 ALS diagnostic finding anatomic site ALSDiagnosFindingAntmicSite Region of the body examined for signs of ALS (Amyotrophic Lateral Sclerosis) Region of the body examined for signs of ALS (Amyotrophic Lateral Sclerosis Region Bulbar;LUE;RUE;Trunk;LLE;RLE;Respiratory Bulbar;LUE (left upper extremity);RUE (right upper extremity);Trunk;LLE (left lower extremity);RLE (right lower extremity);Respiratory Alphanumeric

For each anatomic site document the examination findings. This CDE is shown only on the CRF as the column heading for a table.

 No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17822 Left upper extremity upper motor neuron clinical indicator LUEUMNClinInd Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the left upper extremity (LUE) region Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the left upper extremity (LUE) regio LUE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C11121 Bulbar upper motor neuron clinical indicator BulbarUMNClinBulbInd Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the bulbar region Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the bulbar regio Bulbar Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric

Record for each body region

 No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17852 Right lower extremity lower motor neuron clinical indicator RLELMNClinInd Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the right lower extremity (RLE) region Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the right lower extremity (RLE) regio RLE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C11122 Bulbar lower motor neuron clinical indicator BulbarLMNClinInd Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the bulbar region Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the bulbar region Bulbar Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric

Record for each body region

 No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17853 Right lower extremity lower motor neuron electromyogram indicator RLELMNEMGInd Indicator of whether an electromyogram (EMG) of the right lower extremity (RLE) region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different nerve roots Indicator of whether an electromyogram (EMG) of the right lower extremity (RLE) region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different n RLE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C11123 Bulbar lower motor neuron electromyogram indicator BulbarLMNEMGInd Indicator of whether an electromyogram (EMG) of the bulbar region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different nerve roots Indicator of whether an electromyogram (EMG) of the bulbar region found lower motor neuron dysfunction (LMN), defined as ongoing denervation and chronic renovation in two muscles innovated by different peripheral nerve and different nerve root Bulbar Yes;No;Not assessed Yes;No;Not assessed Alphanumeric

Record for each body region

 No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17854 Right lower extremity upper motor neuron clinical indicator RLEUMNClinInd Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the right lower extremity (RLE) region Indicator of whether the examination found clinical evidence of upper motor neuron (UMN) dysfunction in the right lower extremity (RLE) regio RLE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C11124 El Escorial revised criteria indicator ElEscorialReviseCriteriaInd Indicator of El Escorial World Federation of Neurology criteria for the diagnosis of amyotrophic lateral sclerosis (ALS) category of diagnostic certainty or confidence Indicator of El Escorial World Federation of Neurology criteria for the diagnosis of amyotrophic lateral sclerosis (ALS) category of diagnostic certainty or confidenc Revised El Escorial Criteria Definite;Probable;Lab supported-probable;Possible;Familial Definite;Probable;Lab supported-probable;Possible;Familial Alphanumeric

Choose one

 No references available Adult Core 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
C17855 Right upper extremity lower motor neuron clinical indicator RUELMNClinInd Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the right upper extremity (RUE) region Indicator of whether the examination found clinical evidence of lower motor neuron (LMN) dysfunction in the right upper extremity (RUE) regio RUE Yes;No;Not assessed;Unknown Yes;No;Not assessed;Unknown Alphanumeric No references available Adult Supplemental 3.00 2013-07-22 16:57:17.79 Symptom, Sign, Diagnosis Criteria Classification Disease/Injury Related Events

Single Pre-Defined Value Selected
CSV