Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


ATLAS Trial Design Blamed For Missing Data On Xarelto ACS Use

Executive Summary

Some members of FDA’s Cardiovascular and Renal Drugs Advisory Committee questioned whether the high rate of study dropouts and consent withdrawals in rivaroxaban’s pivotal trial for acute coronary syndromes resulted from elements of the trial’s design, including patient consent and follow-up procedures and the primary analysis.


Related Content

Recapturing Missing Vital Status Not Enough To Rescue Xarelto ACS Claim
Xarelto Label Expansion Plans Slowed By FDA “Complete Response” On ACS Claim
Regulatory News, In Brief
FDA’s Cardio-Renal AdComm Losing Some Of Its Anticoagulant Experience
FDA Panel Looks Beyond Xarelto’s Missing Data Problems To Broader Reforms
Xarelto Review Sparks Debate Over Feasibility Of A Three-Drug ACS Regimen
ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says
Xarelto Acute Coronary Syndromes Claim Faces Data Quality Hurdle
Xarelto Approval For Stroke Prevention Sets Up Marketing Battle With Pradaxa
ROCKET AF’s Design Causes Headaches For Xarelto Sponsors


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts