CDE Detailed Report
Disease: Amyotrophic Lateral Sclerosis
Subdomain Name: Functional Outcomes
CRF: Clinical Milestones
Displaying 1 - 11 of 11
Subdomain Name: Functional Outcomes
CRF: Clinical Milestones
Displaying 1 - 11 of 11
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C10626 | Condition diary date and time | CondDiaryDateTime | Date (and time, if applicable and known) the diary data are recorded | Date (and time, if applicable and known) the diary data are recorded | Date | 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.). |
Brooks BR, Shodis KA, Lewis DH, Rawling JD, Sanjak M, Belden DS, Hakim H, DeTan Y, Gaffney JM. (1995) Natural History of Amyotrophic Lateral Sclerosis. Advances in Neurology: 68, 163-84. ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm | Adult;Pediatric | Exploratory | 3.00 | 2013-08-28 16:08:00.453 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Free-Form Entry |
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| C10628 | Diary day falls status | DiaryFallsStatus | Describes whether the participant/subject experienced falls on a particular day | The status to report occurrence of fall(s) that the participant/subject experienced on the day of the diary as part of the Clinical Milestones and Events questionnaire | Clinical Events - Falls | No Falls;Near Falls;Falls | No Falls;Near Falls;Falls | Alphanumeric |
If a near fall or falls is checked, indicate the number. |
Brooks BR, Shodis KA, Lewis DH, Rawling JD, Sanjak M, Belden DS, Hakim H, DeTan Y, Gaffney JM. (1995) Natural History of Amyotrophic Lateral Sclerosis. Advances in Neurology: 68, 163-84. | Adult | Exploratory | 3.00 | 2013-07-22 16:57:17.79 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10629 | Diary day falls experienced number | DiaryNearFallDailyCt | Number of falls the participant/subject experienced on a particular day | Number of near falls that the participant/subject experienced on the day of the diary as part of the Clinical Milestones and Events questionnaire | Near Falls | Numeric Values |
Record the number of falls on days when "Falls" is checked/chosen |
Brooks BR, Shodis KA, Lewis DH, Rawling JD, Sanjak M, Belden DS, Hakim H, DeTan Y, Gaffney JM. (1995) Natural History of Amyotrophic Lateral Sclerosis. Advances in Neurology: 68, 163-84. | Adult | Exploratory | 3.00 | 2013-07-22 16:57:17.79 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Free-Form Entry |
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| C10630 | Diary day near falls experienced number | DiaryFallDailyCt | Number of near falls the participant/subject experienced on a particular day | Number of falls that the participant/subject experienced on the day of the diary as part of the Clinical Milestones and Events questionnaire | Falls | Numeric Values |
Record the number of near falls on days when "Near Falls" is checked/chosen |
Brooks BR, Shodis KA, Lewis DH, Rawling JD, Sanjak M, Belden DS, Hakim H, DeTan Y, Gaffney JM. (1995) Natural History of Amyotrophic Lateral Sclerosis. Advances in Neurology: 68, 163-84. | Adult | Exploratory | 3.00 | 2013-07-22 16:57:17.79 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Free-Form Entry |
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| C10632 | Diary day cramps status | DiaryCrampsInd | Describes whether the participant/subject experienced cramps on a particular day | Did the participant/subject experience cramps on the day of the diary as part of the Clinical Milestones and Events questionnaire | Clinical Events - Cramps | No Cramps;Cramps | No Cramps;Cramps | Alphanumeric |
If cramps, indicate the number. |
Brooks BR, Shodis KA, Lewis DH, Rawling JD, Sanjak M, Belden DS, Hakim H, DeTan Y, Gaffney JM. (1995) Natural History of Amyotrophic Lateral Sclerosis. Advances in Neurology: 68, 163-84. | Adult | Exploratory | 3.00 | 2013-07-22 16:57:17.79 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10633 | Diary day cramps experienced number | DiaryCrampsDailyCt | Number of cramps the participant/subject experienced on a particular day | Number of cramps that the participant/subject experienced on the day of the diary as part of the Clinical Milestones and Events questionnaire | Cramps | Numeric Values |
Record the number of cramps on days when "Cramps" is checked/chosen |
Brooks BR, Shodis KA, Lewis DH, Rawling JD, Sanjak M, Belden DS, Hakim H, DeTan Y, Gaffney JM. (1995) Natural History of Amyotrophic Lateral Sclerosis. Advances in Neurology: 68, 163-84. | Adult | Exploratory | 3.00 | 2013-07-22 16:57:17.79 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Free-Form Entry |
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| C10634 | Diary month cramp severity category | DiaryCrampsSevScale | Global severity rating of the cramps experienced by the participant/subject in the past 30 days | Severity of cramps that the participant/subject experienced over the whole diary as part of the Clinical Milestones and Events questionnaire | Global rating of cramp severity over the period | 4;3;2;1;0 | Activity interrupted by severe cramps;More than one cramp per day, or seven per week;Spontaneous cramps one to seven times weekly;Rare cramps, related to voluntary muscle activity;None | Numeric values |
Choose one |
Herndon, R.M. (2006). Handbook of Neurologic Rating Scales, second edition. New York: Demos Medical Publishing, Inc. Brooks BR, Shodis KA, Lewis DH, Rawling JD, Sanjak M, Belden DS, Hakim H, DeTan Y, Gaffney JM. (1995) Natural History of Amyotrophic Lateral Sclerosis. Advances in Neurology: 68, 163-84. | Adult | Exploratory | 3.00 | 2013-07-22 16:57:17.79 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C17774 | Diary cramps date | DiaryCrampsDate | Date in the diary where the participant/subject was evaluated for the presence of cramps as part of the Clinical Milestones and Events questionnaire | Date in the diary where the participant/subject was evaluated for the presence of cramps as part of the Clinical Milestones and Events questionnaire | Date | 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.). |
Brooks BR, Shodis KA, Lewis DH, Rawling JD, Sanjak M, Belden DS, Hakim H, DeTan Y, Gaffney JM. (1995) Natural History of Amyotrophic Lateral Sclerosis. Advances in Neurology: 68, 163-84. | Adult | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Free-Form Entry |
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| C10615 | Clinical event or milestone type | ClinEvntMilestoneTyp | Type of clinical event or milestone pertinent to the disease or disorder | Type of clinical event or milestone pertinent to the disease or disorder | Milestone or Event | Noninvasive ventilation (NIV) utilized;Loss of speech;Loss of ambulation;Percutaneous endoscopic gastrostomy (PEG)/feeding tube placement;Tracheostomy performed;Death;Walk by 17 months old;Speak his/her first words by 12 months;Speak in two word combinations by 2 years;Speak in complete sentences by 3 years;Have a cognitive/learning disability;Attend a day care group (with > 5 other children);Head control;Raise both arms above head simultaneously;Roll completely;Maintain seated position supported;Maintain seated position unsupported;Crawl- combat style;Crawl- four point;Stand with support;Cruise along furniture;Stand without support;Walk with support (hand, braces);Walk independently (without braces);Climb stairs | Noninvasive ventilation (NIV) utilized;Loss of speech;Loss of ambulation;Percutaneous endoscopic gastrostomy (PEG)/feeding tube placement;Tracheostomy performed;Death;Walk by 17 months old;Speak his/her first words by 12 months;Speak in two word combinations by 2 years;Speak in complete sentences by 3 years;Have a cognitive/learning disability;Attend a day care group (with > 5 other children);Head control;Raise both arms above head simultaneously;Roll completely;Maintain seated position supported;Maintain seated position unsupported;Crawl- combat style;Crawl- four point;Stand with support;Cruise along furniture;Stand without support;Walk with support (hand, braces);Walk independently (without braces);Climb stairs | Alphanumeric |
For each clinical event or milestone indicate whether it occurred and if applicable the date(s) it occurred. *If participant/subject died, complete Death CRF |
No references available | Adult;Pediatric | Exploratory | 3.00 | 2013-07-25 08:54:08.2 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10616 | Clinical event or milestone achieved indicator | ClinEvntMilestoneAchvInd | Indicator whether the participant/subject achieved or experienced the specific clinical event or milestone pertinent to the disease or disorder | Indicator whether the participant/subject achieved or experienced the specific clinical event or milestone pertinent to the disease or disorder | Yes/No/Unknown | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one for each clinical event or milestone |
No references available | Adult;Pediatric | Exploratory | 3.00 | 2013-07-25 08:54:08.2 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10617 | Clinical event or milestone date and time | ClinEvntDateTime | Date (and time, if applicable and known) the participant/subject achieved the clinical event or milestone | Date the participant/subject experienced the event as part of the Clinical Milestones and Events questionnaire | Date(s) | Date or Date & Time |
List all, as applicable 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 - http://www.iso.org/iso/iso_catalogue.htm | Adult | Exploratory | 3.00 | 2013-07-22 16:57:17.79 | Clinical Milestones/Events | Functional Outcomes | Outcomes and End Points |
Free-Form Entry |
