CDE Detailed Report

Disease: Amyotrophic Lateral Sclerosis
Sub-Domain: 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 / 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
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

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

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

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

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

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

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

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

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

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

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

CSV