Prior Crohn's Disease Medication Classes

This CRF collects information about prior use of four classes of medications: biologics, immunomodulators, 5-aminosalicylates, and corticosteroids. In the corticosteroids section of the CRF, information is collected information about three different types of corticosteroid dependency: inability to taper, inability to discontinue, and relapse after discontinuation. Sponsors may wish to include additional specific details for each type of dependency (e.g., reference to specific medication doses, dosing duration). Alternatively, an overall dependency status may be collected instead of the three separate types of dependency, as shown in the Prior Crohn's Disease Corticosteroids - Alternative Dependency CRF.

Prior Crohn's Disease Medications - High Level Only
Prior Crohn's Disease Medications
* What is the category for the medication?
* For what indication was the medication taken?
* Was the medication prespecified?
* What is the subcategory for the medication?
* Did the subject previously take any biologic medications to treat Crohn's disease?	No Yes
Did the subject discontinue any biologic medications previously taken to treat Crohn's disease, prior to the baseline visit?	No Yes
Were any biologic medications taken to treat Crohn's disease ongoing as of the baseline visit?	No Yes
* What is the subcategory for the medication?
* What was the observation identifier?
* Did the subject previously take any immunomodulator medications to treat Crohn's disease?	No Yes
Did the subject discontinue any immunomodulator medications to treat Crohn's disease, prior to the baseline visit?	No Yes
Were any immunomodulator medications used to treat Crohn's disease ongoing as of the baseline visit?	No Yes
Were contraindications to immunomodulators the reason for not using immunomodulators to treat Crohn's disease?	No Yes
If Yes, what were the contraindications to immunomodulator treatments?	Pre-existing medical condition Clinically significant adverse reaction to previous immunomodulator treatment
What is the identifier for the pre-existing medical condition?
What was the category of the medical history?
When did the medical history event start relative to the study reference period?
What was the relationship to the non-study medication?
If contraindication was due to intolerance, which condition(s) indicated intolerance?
If "Other", what was the other condition indicating intolerance?
* What is the subcategory for the medication?
* Did the subject previously take any aminosalicylate (5-ASA) medications to treat Crohn's disease?	No Yes
Did the subject discontinue any 5-ASA medications previously taken to treat Crohn's disease, prior to the baseline visit?	No Yes
Were any 5-ASA medications to treat Crohn's disease ongoing as of the baseline visit?	No Yes
* What is the subcategory for the medication?
* What was the observation identifier?
* Did the subject previously take any corticosteroid medications to treat Crohn's disease?	No Yes
Did the subject discontinue any corticosteroid medications previously taken to treat Crohn's disease, prior to the baseline visit?	No Yes
Were any corticosteroid Crohn's disease medications ongoing as of the baseline visit?	No Yes
Were contraindications to corticosteroids the reason for not using corticosteroids to treat Crohn's disease?	No Yes
If Yes, what were the contraindications to corticosteroid treatments?	Pre-existing medical condition Clinically significant adverse reaction to previous corticosteroid treatment
What is the identifier for the pre-existing medical condition?
What was the category of the medical history?
When did the medical history event start relative to the study reference period?
What was the relationship to the non-study medication?
If contraindication was due to intolerance, which condition(s) indicated intolerance?
If "Other", what was the other condition indicating intolerance?
Has the subject been unable to reduce (i.e., taper) the dose of corticosteroid at all without Crohn's disease symptoms recurring?	No Yes
Has the subject been unable to discontinue corticosteroid dosing completely without Crohn's disease symptoms recurring?	No Yes
Has the subject had a relapse (recurrence of Crohn's disease symptoms) within 3 months of discontinuation of corticosteroid medication?	No Yes