| Prior Crohn's Disease Medications - High Level Only |
| Prior Crohn's Disease Medications |
| * What is the category for the medication?
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| * For what indication was the medication taken?
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| * Was the medication prespecified?
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| * What is the subcategory for the medication?
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| * Did the subject previously take any biologic medications to treat Crohn's disease?
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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?
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| * What was the observation identifier?
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| * Did the subject previously take any immunomodulator medications to treat Crohn's disease?
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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? |
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| What was the category of the medical history? |
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| When did the medical history event start relative to the study reference period? |
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| What was the relationship to the non-study medication? |
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| If contraindication was due to intolerance, which condition(s) indicated intolerance? |
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| If "Other", what was the other condition indicating intolerance? |
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| * What is the subcategory for the medication?
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| * Did the subject previously take any aminosalicylate (5-ASA) medications to treat Crohn's disease?
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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?
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| * What was the observation identifier?
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| * Did the subject previously take any corticosteroid medications to treat Crohn's disease?
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No Yes |
| Did the subject discontinue any corticosteroid medications previously taken to treat Crohn's disease, prior to the baseline
visit?
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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? |
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| What was the category of the medical history? |
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| When did the medical history event start relative to the study reference period? |
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| What was the relationship to the non-study medication? |
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| If contraindication was due to intolerance, which condition(s) indicated intolerance? |
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| If "Other", what was the other condition indicating intolerance? |
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| 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?
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No Yes |