Concomitant medications

Concomitant medical products and iherapy dates (exclude treatment of event)... 

Please outline any concomitant medications that are permitted for the duration of the trial. If the medicinal product (s) is currently licensed it is recommended that the current summary of producf characteristics (Previously known as the data sheet) is consulted for information on potential drug interactions. 

I. Concomitant Medical Products and Therapy Dales (Exclude ireaimeni ol event)... 

Specific concomitant medications or consumptions (check specific statin package insert for warnings) fibrates (especially gemfibrozil, but other fibrates too), nicotinic acid (rarely), cyclosporine, azole antifungals such as itraconazole and ketoconazole, macrolide antibiotics such as erythromycin and clarithromycin, protease inhibitors used to treat Acquired Immune Deficiency Syndrome, nefazodone (antidepressant), verapamil, amiodarone, large quantities of grapefruit juice (usually more than 1 quart per day), and alcohol abuse (independently predisposes to myopathy)... 

Office-based serologic testing provides a quick assessment (within 15 minutes) of an exposure to HP, but patients can remain seropositive for up to 1 year after eradication, making the clinical utility of this test limited. Stool antigen assays can be useful for the initial diagnosis or to confirm HP eradication, and unlike the urea breath test, are less affected by concomitant medication use.9... 

Formulate a drug therapy plan, taking into consideration the patient s medical history, concomitant medications, and previous use of medications. 

These qualities make cromolyn an option for patients with multiple comorbidities and concomitant medications. Cromolyn is an alternative for patients in whom antihistamines are too sedating and impair work and school performance. Additionally, cromolyn helps to prevent AR when taken prior to exposure, such as visiting a home with a pet.18 Due to its excellent safety profile, cromolyn is a first-line agent in children with AR.11,12... 

Antimicrobial history Drug allergy history Renal and hepatic function Concomitant medications Pregnancy or lactation Compliance potential... 

Is the patient taking the appropriate dose of each medication Are the doses adjusted for renal or hepatic failure Are the doses adjusted for drug interactions with concomitant medications ... 

Concomitant medications and prior medications are collected in one of two forms a list-type free-text format where the medications get coded later by data management, or a pre-categorized data format. Here is the free-text CRF format ... 

An essential detail for the statistical programmer to watch for in prior or concomitant medications data is whether or not the start and stop dates are important for analyses. Unfortunately, it is often the case that the importance of the timing of prior or concomitant medications is not determined until after much of the data have been entered or even after the database is closed to entry. For instance, it may be decided later that a specific concomitant medication has to be watched carefully for interaction with a medication used in the study. If insufficient attention was placed on the quality of the medication start and stop dates, then determining whether there is overlap with study medication is difficult if not impossible. 

Concomitant or prior medications may be used in either safety or efficacy analyses. The presence of specific medications may be used as covariates for inferential analyses. Also, medications are often summarized to show that the therapies under study come from medically comparable populations. Medications may be used to determine protocol compliance and to help define a protocol-compliant study population. Concomitant medications may be examined to determine whether they interact with study therapy or whether they can explain the presence of certain adverse events. From a CDISC perspective, prior medications would be considered a finding while concomitant medications would be considered an intervention. 

Imagine you have a data set of adverse event data and a data set of concomitant medications, and you want to know if a concomitant medication was given to a patient during the time of the adverse event. The following program defines the two data sets and joins them with PROC SQL so that you get all medications taken during any specific... 

MERGE/JOIN ADVERSE EVENTS WITH CONCOMITANT MEDICATIONS. 

Here you can see that each adverse event that was experienced has now been merged with each concomitant medication taken during that time. This is due to the SQL SELECT statement ON clause, which allows for complicated logic to be applied to the join. 

The following is a table specification for an overall summary of concomitant medications. As a rule for this summary, a patient should be counted only once per medication. Denominators are defined as the sum of all patients who received the specified study therapy. 

The following example relies on more PROC SQL, a little DATA step programming, a few SAS macro variables, and a final PROC REPORT for table presentation. Here are the concomitant medication summary annotated SAS program, notes for the program, and the output. 

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