CDE Detailed Report

Methylprednisone/Corticosteroids:

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

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.

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

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

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.

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

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.

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.

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.

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

Within the last four weeks

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.

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