Clinical Trial Expedited Safety Report

Known as: Investigational New Drug (IND) Safety Report, CIOMS Report, MedWatch 
Records describing relevant findings and notifications of unexpected serious adverse reactions and other safety information, which is submitted by a… (More)
National Institutes of Health

Papers overview

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Highly Cited
2017
Highly Cited
2017
Torsades de pointes (TdP)-an uncommon but life-threatening polymorphic ventricular tachycardia-is almost always drug induced. The… (More)
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Highly Cited
2011
Highly Cited
2011
BACKGROUND Rituximab has been associated with hepatitis B virus reactivation (HBV-R). However, the characteristics and scope of… (More)
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2010
2010
BACKGROUND Epinephrine auto-injectors provide life-saving prehospital treatment for individuals experiencing anaphylaxis in… (More)
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Highly Cited
2004
Highly Cited
2004
Thrombosis is a rare but well-recognized potential complication of Factor VIII Inhibitor Bypass Activity (FEIBA) infusion… (More)
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Highly Cited
2001
Highly Cited
2001
BACKGROUND Infliximab is a humanized antibody against tumor necrosis factor alpha (TNF-alpha) that is used in the treatment of… (More)
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Highly Cited
2001
Highly Cited
2001
Clozapine is a potent antipsychotic agent that has been marketed since 1990. Several published reports of diabetes mellitus… (More)
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Review
2000
Review
2000
Potential and documented interactions between alternative therapy agents and warfarin are discussed. An estimated one third of… (More)
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Highly Cited
1999
Highly Cited
1999
Spontaneous reporting systems like MEDWATCH can be effective in revealing unusual or rare adverse events that occur with the use… (More)
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Highly Cited
1998
Highly Cited
1998
CONTEXT Erythromycin is a widely used antibiotic that infrequently causes QT-prolongation and torsades de pointes cardiac… (More)
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