CDE Detailed Report

Disease: Myasthenia Gravis
Sub-Domain: Therapies
CRF: Gastrointestinal Therapies

Displaying 1 - 33 of 33
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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
C12217 Gastrointestinal therapy continuous feed formula rate GITherapContinFeedFormulRat Rate, in mL/hr, at which the participant/subject receives formula if receiving continuous feeding 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

millimeter per hour
C17883 Gastrointestinal therapy water flush status GITherapyWaterFlushStatus The status of whether water was used to flush the participant/subject's feeding tube, if applicable 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 references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12205 Gastrointestinal therapy feed tube placement method type GITherapFeedTubPlcmntMethdTyp Type of method by which the participant/subject's feeding tube was placed 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 3.00 2013-07-25 08:54:08.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12218 Gastrointestinal therapy formula name GITherapyFormulaName Name of the formula taken by the participant/subject for non-continuous feeding 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data 255

Free-Form Entry

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 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 references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

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 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C12220 Gastrointestinal therapy estimate caloric intake value GITherapyEstCaloricIntakeVal Value of the participant/subject's caloric intake received through formula Value of the participant/subject's caloric intake received through formula Estimated caloric intake Numeric Values

Record the estimated caloric intake in kilocalories (kc) This element applies to both Tables 1 and 2.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

kilocalorie
C17885 Gastrointestinal therapy other feed tube text GITherapyOtherFeedTubeTxt Text identification of unlisted tube type through which the participant/subject receives therapeutic tube feedings Text identification of unlisted tube type through which the participant/subject receives therapeutic tube feedings Tube Type: Other, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data 255

Free-Form Entry

C12207 Gastrointestinal therapy take nutrition supplement indicator GITherTakeNutritionSupplInd Indicator whether the participant/subject is taking nutritional supplements 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12221 Gastrointestinal therapy water flush dose GITherapyWaterFlushDose Dose, with unit of measurement, of water used to flush the participant/subject's feeding tube, if applicable Dose, with unit of measurement, of water used to flush the participant/subject's feeding tube, if applicable Amount of water flush Alphanumeric

Record the amount of water flush and include the corresponding units. If no water flush, check "N/A - no water flush" This element applies to Table 1 only

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data 255

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 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 references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12208 Gastrointestinal therapy nutrition supplement type GITherpyNutritionSupplementTyp Type(s) of nutritional supplement(s) being taken by the participant/subject 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Multiple Pre-Defined Values Selected

2183828
C12222 Gastrointestinal therapy other oral intake text GITherapyOthrOralIntakeTxt Text of other nutriment taken orally, if any Text of other nutriment taken orally, if any Other Oral Intake Alphanumeric

This element applies to both Tables 1 and 2.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data 255

Free-Form Entry

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 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data 4000

Free-Form Entry

C12209 Gastrointestinal therapy feed schedule table number GITherapyFeedScheduleTableNum Number of the table used to describe the participant/subject's feeding schedule 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 3.00 2013-07-25 08:54:08.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12223 Gastrointestinal therapy other oral intake estimate caloric value GITherapOthrOrlIntkEstCalVal Value of the subject/participant's caloric intake received through other oral intake Value of the subject/participant's caloric intake received through other oral intake Estimated Calories Numeric Values

Record the estimated caloric intake in kilocalories (kc) This element applies to both Tables 1 and 2.

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

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 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 references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data 4000

Free-Form Entry

2183828
C12198 Gastrointestinal therapy received indicator GITherapyRecieveInd Indicator of whether the participant/subject is currently receiving any gastrointestinal (GI) therapies. 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12210 Gastrointestinal therapy feed type GITherapyFeedTyp Type of feeding received by the participant/subject 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12224 Gastrointestinal therapy feed schedule start date GITherapFeedSchedStrtDate Date on which the feeding schedule for gastrointestinal therapy began Date on which the feeding schedule for gastrointestinal therapy began Start of Feeding Schedule: 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

C12199 Gastrointestinal therapy feed method type GITherapyFeedMethodTyp Type of method by which the participant/subject receives therapeutic feedings 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12212 Gastrointestinal therapy feed duration GITherapyFeedDur Duration of feedings received by the participant/subject 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

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 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 3.00 2013-07-25 08:54:08.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

C12200 Gastrointestinal therapy feed tube type GITherapyFeedTubeTyp Type of tube through which the participant/subject receives therapeutic tube feedings 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12213 Gastrointestinal therapy continuous feed start time GITherapContinFeedStrtTime Time of day that the participant/subject's continuous feeding is normally begun 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

C12533 Gastrointestinal therapy daily feed value GITherapyDailyFeedVal Number of times per day that the participant/subject receives feedings Number of times per day that the participant/subject receives feedings Number of Times per Day Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

C12202 Gastrointestinal therapy fundoplication indicator GITherapyFundoplicationInd Indicator whether the participant/subject has had fundoplication surgery Indicator whether the participant/subject has had fundoplication surgery Fundoplication? Yes;No Yes;No Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Single Pre-Defined Value Selected

C12214 Gastrointestinal therapy continuous feed end time GITherapContinFeedEndTime Time of day that the participant/subject's continuous feeding is normally ended 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

C12534 Gastrointestinal therapy formula grade GITherapyFormulaGrade Grade, in cal/oz, of formula taken by the participant/subject if receiving continuous feeding Grade, in cal/oz, of formula taken by the participant/subject if receiving continuous feeding Formula Type Alphanumeric

cal/oz

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data 255

Free-Form Entry

calories per ounce
C12203 Gastrointestinal therapy fundoplication date GITherapyFundoplicationDate Date on which the participant/subject had fundoplication surgery 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

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 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

milliliter
C12535 Gastrointestinal therapy feed schedule end date GITherapFeedSchedEndDat Date on which the feeding schedule for gastrointestinal therapy ended, if applicable Date on which the feeding schedule for gastrointestinal therapy ended, if applicable End of Feeding Schedule: 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

C12204 Gastrointestinal therapy fundoplication age value GITherapyFundoplicationAgeVal Value of the participant/subject's age at which s/he had fundoplication surgery 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 3.00 2013-07-24 11:38:01.2 Gastrointestinal Therapies Therapies Treatment/Intervention Data

Free-Form Entry

year
CSV