CDE Detailed Report
Disease: Spinal Muscular Atrophy
Subdomain Name: Therapies
CRF: Gastrointestinal Therapies
Displaying 1 - 33 of 33
Subdomain Name: Therapies
CRF: Gastrointestinal Therapies
Displaying 1 - 33 of 33
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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| 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 |
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| 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 | |||||||||
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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) therapie | 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 |
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| 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 | |||||||||
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 ende | 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 |
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| 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 |
