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Dear Sir,In a BA/BE study if a subject develops fever just few hours
before discharge (check-out) from CPU, after treatment the event is
resolved but due to this his discharge is delayed or prolonged.
Is this a SAE or not?
According to GCP, prolongation of existing hospitalization
isconsidered as SAE. So in this above situation is it considered as
SAE or not ? If so please explain?
Thanks and Regards,Dr.Sridhar
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The following message was posted to: PharmPK
Dear sridhar,
It is not consider SAE as you can review the safety guideline for more
details at E2 of ICH.
If the subject has fever during the discharge and duration in
hopitalization is required than it is good example for safety point
that you try to convience him/her for better follow up.
by definition of SAE:
Serious Adverse Event or Adverse Drug Reaction
During clinical investigations, adverse events may occur which, if
suspected to be medicinal product-related (adverse drug reactions),
might be significant enough to lead to important changes in the way
the medicinal product is developed (e.g., change in dose, population,
needed monitoring, consent forms). This is particularly true for
reactions which, in their most severe forms, threaten life or
function. Such reactions should be reported promptly to regulators.
prolongation of existing hopitalization is that to treat the subject
with ICU for any singnificant changes.
Examples of such events are intensive treatment in an emergency room
or at home for allergic bronchospasm; blood dyscrasias or convulsions
that do not result in hospitalisation; or development of drug
dependency or drug abuse. (E2A)
regards,
paresh
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The following message was posted to: PharmPK
Hi Shirdhar,
CPU is not a hospital, therefore delay in discharge
does not catogerize fever which has resolved as SAE.
In case he was hopitalised for treating the
condition, it would be considered as SAE.
More
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The following message was posted to: PharmPK
Dear Sridhar,
Actually prolongation of existing hospitalization is more applicable to
clinical studies where the trials are done in patients. It means the
subject's hospitalization is prolonged during the trial with the
particular drug compared with the standard treatment.
In BA/BE studies we are housing the healthy subjects and only during any
adverse events they will be hospitalized (if needed).
But this may be applicable to BA/BE study of drugs which are done in
patients. Eg. Cytotoxic drugs and drugas like Felbamate (anti-epileptic
with more side effects (aplastic anaemia)
Waiting for expert's opinion
Mohammed Muhiyideen,
Apotex Research Pvt. Ltd.,
Banagalore,
India.
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The following message was posted to: PharmPK
Dear Sridhar
First try to find out the reason of fever. Based on this you should
categorize this AE.
Thanks.
Dr Sajjad A Desai
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