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All Vedo
Clinical Trials, PI & Misc
100
300 MG, 30 minutes at zero, two, six weeks, then every 8 weeks thereafter
What is the dosing
100
Pregnancy Category
What is Category B
200
Clinical remission at 52 weeks 42%, response was 57%
What is the Gemini 1 Trial
200
Patient counseling information required
What is labeled in the PI
300
No black box warning
What is the safety profile
300
although no PML, a risk of PML cannot be ruled out, monitor patients for any new or worsening neurological signs or symptoms
What is the warning and precaution section
400
clinical remission at both weeks 6 and 52= 21% vs 12% placebo
What is Gemini I
400
Nasopharyngitis 13%
What is highest adverse event
500
improvement in endoscopic appearance 52%,
What is Gemini I (UC)
500
Clinical response= 39% and 38% for 8 weeks and 4 weeks 21% placebo
What is Gemini II (CD)