Reply
Wed 7 Dec, 2011 11:06 pm
Does it refer to "that (FDA is working...) is based on?" Or does it refer to "the reports of bleeding are based on?"
Context:
December 7, 2011 (Rockville, Maryland) — The US Food and Drug Administration (FDA) announced today that it is now investigating postmarketing reports of serious bleeding events in patients taking dabigatran etexilate (Pradaxa, Boehringer Ingelheim) [1].
"FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa," according to the drug safety communication issued by the agency.
@oristarA,
I'm pretty sure it is "...reports of bleeding...are occurring more commonly than would be expected
in reference to...the clinical trial that supported the approval of Pradaxa"
@RexDraconis111,
RexDraconis111 wrote:
I'm pretty sure it is "...reports of bleeding...are occurring more commonly than would be expected in reference to...the clinical trial that supported the approval of Pradaxa"
Thank you.
It becomes clearer for me.
What I got from you is: what is normaly expected (of Paradaxa) is based on observations in the large clinical trial that supported the approval of Pradaxa.
Am I on right track?
Stumble It!
Tweet This
Bookmark on Delicious
Share on Facebook
Share on MySpace