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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease:
Sub-Domain: Therapies
CRF: Gastrointestinal Therapies
Item count: 99 (33 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C12198
Gastrointestinal therapy received indicator
GITherapyRecieveInd
Indicator of whether the participant/subject is currently receiving any gastrointestinal (GI) therapies.
Is the participant/subject on any GI therapies?
Yes;No;
Yes;No;
Alphanumeric
If this question is answered No then leave the rest of the form blank.
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Gastrointestinal Therapies indicator
 
Single Pre-Defined Value Selected
       
C12199
Gastrointestinal therapy feed method type
GITherapyFeedMethodTyp
Type of method by which the participant/subject receives therapeutic feedings
Are the feedings given
Orally only;Tube Feeding only;Combination oral and tube feeding;
Orally only;Tube Feeding only;Combination oral and tube feeding;
Alphanumeric
If Orally only is answered, skip to question 5.
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
GI feeding type
 
Single Pre-Defined Value Selected
       
C12200
Gastrointestinal therapy feed tube type
GITherapyFeedTubeTyp
Type of tube through which the participant/subject receives therapeutic tube feedings
Tube Type
Nasogastric;Nasojejunal;Gastrostomy (G-tube);Gastrojejunal;Jejunal;Other, specify;
Nasogastric;Nasojejunal;Creation of an artificial external opening into the stomach for nutritional support or gastrointestinal compression;Gastrojejunal;Jejunal;Other, specify;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
GI feeding tube type
 
Single Pre-Defined Value Selected
       
C18826
Gastrointestinal therapy feed tube other text
GITherapyFeedTubeOTH
The free-text field related to 'Gastrointestinal therapy feed tube type' specifying other text. Type of tube through which the participant/subject receives therapeutic tube feedings
Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C12532
Gastrointestinal therapy feed tube first place date
GITherapFeedTube1stPlaceDate
Date on which the participant/subject's feeding tube was first placed
Date Feeding Tube First Placed:
  
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.).
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding tube placed date
 
Free-Form Entry
       
C17883
Gastrointestinal therapy water flush status
GITherapyWaterFlushStatus
The status of whether water was used to flush the participant/subject's feeding tube, if applicable
 
N/A - no water flush;
N/A - no water flush;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C12202
Gastrointestinal therapy fundoplication indicator
GITherapyFundoplicationInd
Indicator whether the participant/subject has had fundoplication surgery
Fundoplication?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Fundoplication indicator
 
Single Pre-Defined Value Selected
       
C12203
Gastrointestinal therapy fundoplication date
GITherapyFundoplicationDate
Date on which the participant/subject had fundoplication surgery
Fundoplication? If Yes, a. 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.).
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Fundoplication date
 
Free-Form Entry
       
C12204
Gastrointestinal therapy fundoplication age value
GITherapyFundoplicationAgeVal
Value of the participant/subject's age at which s/he had fundoplication surgery
Fundoplication? If Yes, b. Age:
  
Numeric Values
Only answered if Nissin fundoplication is answered Yes. Record the age of the subject when Nissen fundoplication was performed Age is a derived variable; Use Date of Birth from Demographics form
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Fundoplication age
 
Free-Form Entry
  
year
    
C17884
Gastrointestinal therapy continuous feed start time value
GITherapContinFeedStrtTimeVal
The value for the time of day that the participant/subject's continuous feeding is normally begun
Continuous feeding start time
am;PM;
am;PM;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C17885
Gastrointestinal therapy other feed tube text
GITherapyOtherFeedTubeTxt
Text identification of unlisted tube type through which the participant/subject receives therapeutic tube feedings
Tube Type: Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
 
255
Free-Form Entry
       
C12205
Gastrointestinal therapy feed tube placement method type
GITherapFeedTubPlcmntMethdTyp
Type of method by which the participant/subject's feeding tube was placed
Method of placement
Microscopic Laparotomy;Interventional Radiology;Percutaneous Endoscopic Gastrostomy;
Microscopic Laparotomy;Interventional Radiology;Percutaneous Endoscopic Gastrostomy;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Method placement type
 
Single Pre-Defined Value Selected
       
C12206
Gastrointestinal therapy medication type
GITherapyMedicationTyp
Type(s) of medications taken by the participant/subject for her/his gastrointestinal (GI) therapy
Medications
PPI;H2 blocker;Gastric motility;Polyethylene glycol;
PPI;H2 blocker;Gastric motility;Polyethylene glycol;
Alphanumeric
For each medication used for GI therapy, record on the Concomitant Medication form with detailed information about dosing and frequency.
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
GI medications
 
Multiple Pre-Defined Values Selected
       
C12207
Gastrointestinal therapy take nutrition supplement indicator
GITherTakeNutritionSupplInd
Indicator whether the participant/subject is taking nutritional supplements
Is the participant/subject taking nutritional supplements?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Nutritional supplement taken indicator
 
Single Pre-Defined Value Selected
       
C12208
Gastrointestinal therapy nutrition supplement type
GITherpyNutritionSupplementTyp
Type(s) of nutritional supplement(s) being taken by the participant/subject
Is the participant/subject taking nutritional supplements? If yes, specify supplements:
Turmeric;Fiber;Creatine;CoQ10;Other, specify;
Turmeric;Fiber;Creatine;CoQ10;Other, specify;
Alphanumeric
Check all that apply
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Nutritional supplement type
 
Multiple Pre-Defined Values Selected
     
2183828
 
C18827
Gastrointestinal therapy nutrition supplement other text
GITherpyNutritionSupplementOTH
The free-text field related to 'Gastrointestinal therapy nutrition supplement type' specifying other text. Type(s) of nutritional supplement(s) being taken by the participant/subject
Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
 
4000
Free-Form Entry
     
2183828
 
C12209
Gastrointestinal therapy feed schedule table number
GITherapyFeedScheduleTableNum
Number of the table used to describe the participant/subject's feeding schedule
Feeding schedule
Table 1;Table 2;
Table 1;Table 2;
Alphanumeric
Complete either Table 1 or Table 2, but not both, and questions 10 and 11 to capture data on the participant/subject's original feeding schedule and any changes to the feeding schedule over the course of the study.
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding schedule table number
 
Single Pre-Defined Value Selected
       
C12210
Gastrointestinal therapy feed type
GITherapyFeedTyp
Type of feeding received by the participant/subject
Feeding Schedule: Table 1: Type of feeding
Bolus G tube;Continuous G tube;Oral liquid supplement intake;
Bolus G tube;Continuous G tube;Oral liquid supplement intake;
Alphanumeric
Choose only one. This element applies to Table 1 only
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding method type
 
Single Pre-Defined Value Selected
       
C12212
Gastrointestinal therapy feed duration
GITherapyFeedDur
Duration of feedings received by the participant/subject
Feeding Schedule: Table 1: Duration
  
Numeric Values
Record the duration in HH:MM
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding duration
 
Free-Form Entry
       
C12213
Gastrointestinal therapy continuous feed start time
GITherapContinFeedStrtTime
Time of day that the participant/subject's continuous feeding is normally begun
Continuous feeding start time
  
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.).
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding start time
 
Free-Form Entry
       
C12214
Gastrointestinal therapy continuous feed end time
GITherapContinFeedEndTime
Time of day that the participant/subject's continuous feeding is normally ended
Continuous feeding end time
  
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.).
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding end time
 
Free-Form Entry
       
C17887
Gastrointestinal therapy continuous feed end time value
GITherapContinFeedEndTimeVal
The value for the time of day that the participant/subject's continuous feeding is normally ended
Continuous feeding end time
am;PM;
am;PM;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C12533
Gastrointestinal therapy daily feed value
GITherapyDailyFeedVal
Number of times per day that the participant/subject receives feedings
Number of Times per Day
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding times per day value
 
Free-Form Entry
       
C12216
Gastrointestinal therapy feed formula dose
GITherapyFeedFormulaDose
Dose, in mL, of formula that the participant/subject receives at each feeding for non-continuous feeding
Amount of Formula per Feed
  
Numeric Values
Include units - e.g., 240 ml
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding amount measurement
 
Free-Form Entry
  
milliliter
    
C12217
Gastrointestinal therapy continuous feed formula rate
GITherapContinFeedFormulRat
Rate, in mL/hr, at which the participant/subject receives formula if receiving continuous feeding
Rate
  
Numeric Values
mL/hr
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Feeding rate
 
Free-Form Entry
  
millimeter per hour
    
C12218
Gastrointestinal therapy formula name
GITherapyFormulaName
Name of the formula taken by the participant/subject for non-continuous feeding
Formula Name
  
Alphanumeric
Trade or Generic
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Gastrointestinal Therapies
Therapies
Treatment/Intervention Data
Formula name
255
Free-Form Entry
       
12-17-2018
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