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Dear All,
I have one query regarding adverse event:
The exclusion criterion for diastolic blood pressure is defined as
"less than 60 - more than 90" and for systolic blood pressure "less
than 110 - more than 140" in the protocol for Antihypertensive drug.
If the blood pressure is recorded as out of range (mentioned as
exclusion criteria in the protocol), let's say '72/106' after dosing,
is it considered as adverse event?
Thanks with Regards,
Prakash Patel
ClinSearch Labs. Pvt. Ltd.
www.clinsearchlabs.com
[Wouldn't this be another, different, criteria that would need to be
set before the study - db]
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The following message was posted to: PharmPK
Prakash,
In my experience the logical approach is to specify in the protocol
that
reductions in blood pressure after an anti-hypertensive are
expected, that
you will measure and analyse them, because they would not then be
regarded
as an adverse event. If you have not predicted them in the protocol
then
you will have to record them as such despite their non-significant
nature in
a clinical sense.
Andrew
--
Andrew Sutton, MBBS, MD(London), FFA
Guildford Clinical Pharmacology Ltd.
The Technology Centre, Occam Road
Guildford, Surrey, UK. GU2 7YG
Tel: +44 (0)1483 455375. Direct: 688303
Mobile +44 (0) 7770 820 145 (To 5pm EST)
URL: www.gcpl.co.uk
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Prakash,
I do not think that a reduction of a few mm of mercury from the
baseline recordings would qualify as an adverse event. The words used
to describe an adverse event are 'an untoward medical event'. What
would be untoward if in an asymptomatic subject the systolic blood
pressure does not record a significant fall or remains above the
generally acceptable limit of 90 mm Hg? Like pointed out by you it
would be better to have separate predefined criteria before the study.
Vikas
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