Prior Crohn's Disease Medication Class- Biologics
Prior Crohn's Disease Medication Class- Biologics 1
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What is the category for the medication?
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For what indication was the medication taken?
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What is the subcategory for the medication?
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What was the medication identifier?
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What was the name of the biologic drug taken for Crohn's disease?
What was the start date of this biologic?
01 Jan 2000
What was the end date of this biologic?
01 Jan 2000
How many months did the subject take this biologic?
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What was the maximum dose amount of this biologic?
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What was the unit of the maximum dose amount of this biologic?
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What was the frequency of the maximum dose amount of this biologic?
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What was the final dose amount of this biologic?
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What was the final dose amount unit of this biologic?
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What was the frequency of the final dose amount of this biologic?
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What was the route of administration of this biologic?
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What was the primary reason for discontinuation of this biologic?
Choose
Primary non-responder
Secondary non-responder
Intolerance
Completed induction phase
Treatment complete
Loss of insurance
Cost
Treatment no longer indicated
Other
Unknown
If primary non-responder, what were the signs and symptoms leading to discontinuation of treatment?
Choose
Lack of improvement or worsening of stool frequency
Lack of improvement or worsening of abdominal pain
Lack of improvement or worsening of Crohn's disease related fever
Lack of improvement or worsening of draining fistula or development of new fistula
Lack of improvement or worsening of rectal bleeding
Initiation or increased dosage of antidiarrheal medication
Lack of improvement or worsening in the endoscopic appearance of the colonic mucosa
Other
If "Other", specify.
If secondary non-responder, what were the signs and symptoms leading to treatment discontinuation?
Choose
Worsening of stool frequency
Worsening of abdominal pain
Occurrence or worsening of Crohn's disease related fever
Worsening of draining fistula or development of new fistula
Worsening of rectal bleeding
Antidiarrheal medication required
Worsening in the endoscopic appearance of the colonic mucosa
Other
If "Other", specify.
Prior Crohn's Disease Medication Class- Biologics 2
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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 treatment was discontinued due to intolerance, what was the condition indicating intolerance?
Choose
Serious infection
Hepatotoxicity
Hypersensitivity
Demyelinating disease
Lupus-like syndrome
Significant injection site reactions
Significant acute administration reactions
Significant delayed administration reactions
Prior Crohn's Disease Medication Class- Biologics 3
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What was the subcategory of the medical history?
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What is the observation group identifier?
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If significant injection site reactions, what were the specific signs and symptoms causing treatment intolerance?
Significant bruising
Erythema
Hemorrhage
Prior Crohn's Disease Medication Class- Biologics 4
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What was the subcategory of the medical history?
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What is the observation group identifier?
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If significant acute administration reactions, what were the specific signs and symptoms causing treatment intolerance?
Choose
Fever greater than 100 F or 37.8 C
Chills or rigors
Itching
Rash
Flushing
Urticuria or angioedema
Breathing difficulties
Clinical hypotension
Prior Crohn's Disease Medication Class- Biologics 5
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What was the subcategory of the medical history?
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What is the observation group identifier?
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If significant delayed administration reactions, what were the signs and symptoms causing treatment intolerance?
Choose
Myalgias
Arthralgias
Malaise
Rash
Fever
Other symptom
If "Other symptom", specify.
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Mandatory field