CDE Detailed Report

Disease: Spinal Cord Injury
Subdomain Name: General Health History
CRF: Prior and Concomitant Medications

Displaying 1 - 35 of 35
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
C02011 Medication prior or concomitant dose frequency MedctnPriorConcmtntDoseFreq Frequency of use of a prior/concomitant medication Frequency of use of a prior/concomitant medicatio Frequency BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;alt. d.;HS;PRN;OTH;UNK;NA twice a day;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;every morning;every evening;one a day;every other day (on alternate days);at bedtime;as needed;Other, specify;unknown;Not applicable Alphanumeric

Record how often the medication is being taken. See the data dictionary for additional information on coding the frequency using CDISC SDTM Frequency Terminology.

CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/ Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

3162733
C06196 Oral laxative drops liquid type OrlLaxDropsLiquidTyp Type of drops or liquid oral laxative, a medicine taken by mouth to encourage bowel movements to relieve constipation taken within the last four weeks Type of drops or liquid oral laxative, a medicine taken by mouth to encourage bowel movements to relieve constipation taken within the last four week If yes, drops or liquids Bulking/osmotic;Irritant Bulking/osmotic;Irritant Alphanumeric

Oral laxatives are commonly used by individuals with SCI. A large number of oral laxatives exist either as drops or tablets and it is impractical to give a full list within the frames of this data set. Commonly used bulking or osmotic agents are lactulose, psyllium, magnesium and sorbitol. Commonly used irritant laxatives are bisacodyl and sodium picosulphate. Cisapride, previously the most commonly used oral prokinetic agent, is now withdrawn from common use and is rarely used inpersons with SCI.

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Prior and Concomitant Medications General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C19187 Medication affecting bowel function constipating agent other text MedAffBowlFxnConstAgntOTH The free-text field related to 'Bowel function medication indicator' specifying other text. Indicator for medication affecting bowel function/constipating agents (within the last four weeks) The free-text field related to 'Bowel function medication indicator' specifying other text. Indicator for medication affecting bowel function/constipating agents (within the last four weeks) Other, specify Alphanumeric Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Exploratory 1.00 2014-06-02 11:24:00.0 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

C02013 Medication prior or concomitant dose unit of measure UCUM code MedctnPriorOrConDseUOMUCUMCode Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM) Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM) Dose Units Alphanumeric

Code the unit of measure of the medication dosage using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.10 2022-08-02 14:42:09.0 Prior and Concomitant Medications General Health History Participant History and Family History 255

Free-Form Entry

C06251 Medication cardiovascular function type MedctnCardioFnctnTyp Type of medication affecting cardiovascular functions. Type of medication affecting cardiovascular functions. If Yes, indicate type of medication affecting cardiovascular function Anticholinergics;Antihypertensives;Antihypotensives;Cardiac;Other, specify Anticholinergics;Antihypertensives (beta-blocker, antiarhythmics, ACE etc);Antihypotensives;Cardiac (digitalis, anti-arrhythmics etc);Other, specify Alphanumeric Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Prior and Concomitant Medications General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C19188 Oral laxative medication indicator OralLaxativeMedicationInd Indicator for oral laxative medication use (within the last four weeks) Indicator for oral laxative medication use (within the last four weeks) Oral laxatives (within the last four weeks) No;Yes;Unknown No;Yes;Unknown Alphanumeric

Within the last four weeks

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Exploratory 1.00 2014-06-02 11:39:57.0 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

C02014 Medication prior or concomitant name MedctnPriorConcomName Name of the prior/concomitant agent or drug administered Name of the prior/concomitant agent or drug administere Medication Name Alphanumeric

Record the verbatim name (generic or trade name) of the medication the participant/subject reports taking. See the data dictionary for additional information on coding the medication name using RXNorm.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

3162728
C06448 Spasticity spasm treat last four week indicator SpasctySpsmTrtLst4WkInd Indicator of whether the person with SCI has received any kind of treatment for spasticity/spasms within the last four weeks Indicator of whether the person with SCI has received any kind of treatment for spasticity/spasms within the last four week Any treatment for spasticity/spasms within the last four weeks Yes;No;Unknown Yes;No;Unknown Alphanumeric

A "yes" is indicated if any kind of treatment has been used for spasticity over the last four weeks regardless of whether it was or was not prescribed. This may include physical, pharmacological, surgical or other. Four weeks has been chosen to give recent status.

Biering-SØrensen F, Burns AS, Curt A, Harvey LA, Jane Mulcahey M, Nance PW, Sherwood AM, Sisto SA. International spinal cord injury musculoskeletal basic data set. Spinal Cord. 2012 Nov;50(11):797-802. doi: 10.1038/sc.2012.102. Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19189 Oral laxative tablets capsules granulates other text OralLaxTabCapGrnlOTH The free-text field related to 'Oral laxative tablets capsules granulates type' specifying other text The free-text field related to 'Oral laxative tablets capsules granulates type' specifying other tex Other, specify Alphanumeric Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Exploratory 1.00 2014-06-02 13:19:50.0 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

C02015 Medication prior or concomitant route type MedctnPriorOrConcomRteTyp Type of access route for the administration of the prior/concomitant medication Type of access route for the administration of the prior/concomitant medication Route Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By Ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify Alphanumeric

Record the route of administration. Acceptable responses for Route are shown below the medication table.

No references available Adult;Pediatric Supplemental 3.10 2022-08-02 14:44:16.0 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

3162743
C18736 Medication prior or concomitant dose unit of measure other text MedctnPriorOrConcomDoseUoMOTH The free-text field related to 'Medication prior or concomitant dose unit of measure', specifying other text. Dosage unit of measure of the prior or concomitant medication administered The free-text field related to 'Medication prior or concomitant dose unit of measure', specifying other text. Dosage unit of measure of the prior or concomitant medication administere Other, specify Alphanumeric

Record the units of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 2.10 2022-08-02 14:27:44.0 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

3162730
C19190 Examination day cardiovascular function medication indicator ExamDayCardioFunctMedicatnInd Indicator for medication affecting cardiovascular function on the day of the examination Indicator for medication affecting cardiovascular function on the day of the examination Any medication affecting cardiovascular function on the day of examination No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Exploratory 1.00 2014-06-02 13:21:03.0 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

C02016 Medication prior or concomitant start date and time MedctnPriorOrConcmStrtDateTime The date (and time, if applicable and known) on which the prior/concomitant medication usage began The date (and time, if applicable and known) on which the prior/concomitant medication usage began. Start Date Date or Date & Time

Record the date (and time if applicable to the study) the participant/subject started taking the medication. 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.) and in the format acceptable to the study database. Start Date can be used to distinguish between prior medications and concomitant medications. Studies that need to collect Start Time will need to add fields for time to the form template.

No references available Adult;Pediatric Supplemental 3.10 2022-08-02 16:58:56.0 Prior and Concomitant Medications General Health History Participant History and Family History

Free-Form Entry

3162752
C18737 Medication prior or concomitant route type other text MedctnPriorOrConcomRteTypOTH The free-text field related to 'Medication prior or concomitant route type', specifying other text. Type of access route for the administration of the prior/concomitant medication The free-text field related to 'Medication prior or concomitant route type', specifying other text. Type of access route for the administration of the prior/concomitant medication Other, specify Alphanumeric

Record the route of administration. Acceptable responses for Route are shown below the medication table.

No references available Adult;Pediatric Supplemental 2.00 2022-08-02 16:52:05.0 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

3162743
C19191 Examination day cardiovascular function medication other text ExamDayCardioFunctMedOTH Free-text field for medication affecting cardiovascular function on the day of the examination Free-text field for medication affecting cardiovascular function on the day of the examination Other, specify Alphanumeric Krassioukov A, Alexander MS, Karlsson AK, Donovan W, Mathias CJ, Biering-SØrensen F. International spinal cord injury cardiovascular function basic data set. Spinal Cord. 2010 Aug;48(8):586-90. Adult;Pediatric Exploratory 1.00 2014-06-02 13:32:36.0 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

C02022 Medication prior or concomitant dose unit of measure MedctnPriorOrConcomDoseUOM Dosage unit of measure of the prior or concomitant medication administered Dosage unit of measure of the prior or concomitant medication administered Dose g;mcg;mcL;mg;mL;oz;Other, specify;Unknown;NA gram;microgram;microliter;milligram;milliliter;ounce;Other, specify;Unknown;Not applicable Alphanumeric

Record the units of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.10 2022-08-02 14:36:00.0 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

3162730
C19180 Steroid administration type SteroidAdministrationTyp Type of steroids (methylprednisone/corticosteroids) administered at any point during stay Type of steroids (methylprednisone/corticosteroids) administered at any point during stay Any steroids administered NASCIS II (Methylprednisolone or Solumedrol run as an infusion x 23 or 24 hrs);NASCIS III (Methylprednisolone or solumedrol run as an infusion x 47 or 48 hrs);None;Other, specify;Unknown NASCIS II (Methylprednisolone or Solumedrol run as an infusion x 23 or 24 hrs);NASCIS III (Methylprednisolone or solumedrol run as an infusion x 47 or 48 hrs);None;Other, specify;Unknown Alphanumeric

Methylprednisone/Corticosteroids:

Adult;Pediatric Exploratory 1.00 2014-06-02 10:33:02.0 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

C21670 Medication history date MedctnHistDate Date the medication history was taken Date the medication history was taken Date medication history taken Date or Date & Time Adult;Pediatric Exploratory 3.00 2013-08-28 16:08:00.453 Prior and Concomitant Medications General Health History Participant History and Family History

Free-Form Entry

3162753
C02024 Medication prior or concomitant indication text MedctnPriorConcomIndTxt Text describing reason for administration of a prior/concomitant (nonstudy) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subject Text describing reason for administration of a prior/concomitant (nonstudy) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subjec Indication Alphanumeric

Record the reason the participant/subject gives for taking the medication. If given for an AE, enter exact term from Adverse Event CRF.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

3158920
C19181 Steroid administration other text SteroidAdministrationOTH The free-text field related to 'Steroid administration type' specifying other text. Type of steroids (methylprednisone/corticosteroids) administered at any point during stay The free-text field related to 'Steroid administration type' specifying other text. Type of steroids (methylprednisone/corticosteroids) administered at any point during stay Other, specify Alphanumeric Adult;Pediatric Exploratory 1.00 2014-06-02 10:36:14.0 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

C21671 Urinary tract antibiotic antiseptic use reason UrnTrctAntibioAntisepURsn Reason antibiotics or antiseptics were used for the urinary tract Reason antibiotics or antiseptics were used for the urinary tract Antibiotics/antiseptics For prophylactic reasons;For treatment of urinary tract infection For prophylactic reasons;For treatment of urinary tract infection Alphanumeric Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30. Adult;Pediatric Exploratory 1.00 2016-04-27 10:17:02.0 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

C02002 Medication prior or concomitant use indicator MedctnPriorConcomUseInd Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol Did the patient/participant take any medications __ days before or during the study? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If this question is answered YES then at least one prior/concomitant medication record needs to be recorded. Do NOT record study medications taken (if study has a drug intervention) on this form. Refer to the Study Drug Dosing form to record study medications.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

2220500
C02025 Medication prior or concomitant RXNorm code MedctnPriorConcomRxNormCode Code for name of the prior/concomitant agent or drug administered Code for name of the prior/concomitant agent or drug administere Medication Name Alphanumeric

Code the verbatim name (generic or trade name) of the medication using RXNorm.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Concomitant Medications General Health History Participant History and Family History 255

Free-Form Entry

3162728
C19182 Steroid administration date SteroidAdministrationDate Date at which steroids (methylprednisone/corticosteroids) were administered during stay Date at which steroids (methylprednisone/corticosteroids) were administered during stay Date and time administered 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.).

Adult;Pediatric Exploratory 1.00 2014-06-02 10:38:23.0 Prior and Concomitant Medications General Health History Participant History and Family History

Free-Form Entry

C22779 Vasopressor use date VasopressUseDate Date (and time, if applicable) when the vasopressor was administered Date (and time, if applicable) when the vasopressor was administere Date and time administered Date or Date & Time Adult;Pediatric Exploratory 1.00 2016-10-25 13:44:34.0 Prior and Concomitant Medications General Health History Participant History and Family History

Free-Form Entry

C02003 Medication prior or concomitant ongoing indicator MedctPrConcomOngoingInd Indicator of or description that the prior/concomitant medication usage is ongoing Indicator of or description that the prior/concomitant medication usage is ongoin Ongoing? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. Answer YES if the participant/subject is still taking the medication or NO if the participant/subject has stopped taking the medication.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

2321822
C06023 Urinary tract drug type UrinTractDrgTyp Type of drug, systemic or intravesical, for the urinary tract used Type of drug, systemic or intravesical, for the urinary tract used If yes, indicate type of drugs for the urinary tract used within the last year Antibiotics/antiseptics;Bladder relaxant drugs (anticholinergics, tricyclic antidepressants, etc.);Other,specify;Sphincter/bladder neck relaxant drugs (alpha adrenergic blockers, etc.) Antibiotics/antiseptics;Bladder relaxant drugs (anticholinergics, tricyclic antidepressants, etc.);Other, specify;Sphincter/bladder neck relaxant drugs (alpha adrenergic blockers, etc.) Alphanumeric

Bladder relaxant drugs, i.e. drugs causing relaxation of the detrusor, include anticholinergics, tricyclic antidepressant, etc. These drugs may also be delivered intravesically. This does not include treatment with injections into the detrusor.
Sphincter and bladder neck relaxant drugs include alpha adrenergic blockers, etc. This does not include treatment with injections into the sphincter. Antibiotics and antiseptics used for treatment respective prophylaxis of urinary tract infections are coded separately. For prevention of urinary tract infections, drugs such as methenamine are included. For other possible drugs it is recommended to write them in a text-field, from which it will be possible to retrieve more detailed data when necessary.

Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30. Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Prior and Concomitant Medications General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C19183 Vasopressor use indicator VasopressorUseInd Indicator for use of vasopressor Indicator for use of vasopressor Any vasopressor use No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Exploratory 1.00 2014-06-02 10:40:47.0 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

C53047 Oral laxative tablet capsule granulate type OrlLaxTabCapsGrnlTyp Type of tablets, capsules or granulate oral laxative, a medicine taken by mouth to encourage bowel movements to relieve constipation Type of tablets, capsules or granulate oral laxative, a medicine taken by mouth to encourage bowel movements to relieve constipatio Yes, tablets, capsules or granulates Bulking/osmotic;Irritant;Prokinetics/chloride channel activators;Other, specify Bulking/osmotic;Irritant;Prokinetics/chloride channel activators;Other, specify Alphanumeric

Oral laxatives are commonly used by individuals with SCI. A large number of oral laxatives exist either as drops or tablets and it is impractical to give a full list within the frames of this data set. Commonly used bulking or osmotic agents are lactulose, psyllium, magnesium and sorbitol. Commonly used irritant laxatives are bisacodyl and sodium picosulphate. Cisapride, previously the most commonly used oral prokinetic agent, is now withdrawn from common use and is rarely used inpersons with SCI.

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Prior and Concomitant Medications General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C02006 Medication prior or concomitant dose MedctnPriorOrConcomDose Dose of prior/concomitant medication taken per administration Dose of prior/concomitant medication taken per administration Dose Numeric Values

Record the strength and units of the medication the participant/subject is taking.

No references available Adult;Pediatric Supplemental 3.10 2022-08-02 14:33:32.0 Prior and Concomitant Medications General Health History Participant History and Family History

Free-Form Entry

3162729
C06194 Bowel function medication constipating agent type BwlFUncMedConstAgtTyp Type of medication affecting bowel function / constipating agents Type of medication affecting bowel function / constipating agents If yes, specify medication affecting bowel function/constipating agents Anticholinergics;Narcotics;Other,specify Anticholinergics;Narcotics;Other, specify Alphanumeric

A number of drugs affect gastrointestinal motility. The most commonly used among individuals with SCI are probably anticholinergics and narcotics. Other common examples are: calcium antagonists, diuretics, serotonin reuptake inhibitors, and
spasmolytics. Many drugs affect gastrointestinal function and it is impractical to give an exact list of them all. It does not only include orally taken agents but also patches, suppositories and injections. It does not include laxatives. Constipating agents, especially loperamide, taken by a minority of individuals with SCI against fecal incontinence should also be listed here.

Krogh K, Perkash I, Stiens SA, Biering-SØrensen F. International bowel function basic spinal cord injury data set. Spinal Cord. 2009 Mar;47(3):230-4 Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Prior and Concomitant Medications General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C19184 Urinary tract drug use indicator UrinaryTractDrugUseInd Indicator for urinary tract drugs used within the last year Indicator for urinary tract drugs used within the last year Any drugs for the urinary tract within the last year No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Exploratory 1.00 2014-06-02 10:58:55.0 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

C02008 Medication prior or concomitant end date and time MedctnPriorOrConcomEndDateTime The date (and time, if applicable and known) the administration of the prior/concomitant medication ended The date (and time, if applicable and known) the administration of the prior/concomitant medication ended. End Date Date or Date & Time

Record the date (and time if applicable to the study) the participant/subject stopped taking the medication. 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.) and in the format acceptable to the study database. End Date should be recorded if Continuing Medication is answered NO. Conversely, End Date should remain blank if Continuing Medication is answered YES. Studies that need to collect End Time will need to add fields for time to the form template.

No references available Adult;Pediatric Supplemental 3.10 2022-08-02 16:59:51.0 Prior and Concomitant Medications General Health History Participant History and Family History

Free-Form Entry

3162753
C06195 Constipating agent fecal incontinence drug last four week indicator ConAgFeclInconLstFourWkInd Indicator related to whether a constipating agent or drugs against fecal incontinence were used in the last four weeks Indicator related to whether a constipating agent or drugs against fecal incontinence were used in the last four weeks Constipating agents/drugs against fecal incontinence Yes;No;Unknown Yes;No;Unknown Alphanumeric

(within the last four weeks)

Adult;Pediatric Exploratory 3.00 2013-07-17 09:26:36.973 Prior and Concomitant Medications General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19185 Urinary tract drug use other text UrinaryTractDrugUseOTH The free-text field related to 'Urinary tract drug use indicator' specifying other text. Indicator for urinary tract drugs used within the last year The free-text field related to 'Urinary tract drug use indicator' specifying other text. Indicator for urinary tract drugs used within the last year Yes, other, specify Alphanumeric Biering-SØrensen F, Craggs M, Kennelly M, Schick E, Wyndaele JJ. International Lower Urinary Tract Function Basic Spinal Cord Injury Data Set. Spinal Cord 2008 May;46(5):325-30. Adult;Pediatric Exploratory 1.00 2014-06-02 11:11:36.0 Prior and Concomitant Medications General Health History Participant History and Family History 4000

Free-Form Entry

CSV