Subject: FW: Sovaldi AE report from Armenia_AE5_2017-0303964 and AE6_2017-0303965
From: Maia Nikoleishvili <[email-masked]>
To: SPARC <[email-masked]>
Cc: Farhana Haque <[email-masked]>, [email-masked], [email-masked]
Date: Mon, 13 Nov 2017 16:33:07 +0000

Dear
Colleagues,
Please, find the e-mail below from Armenian contact
point regarding the latest AE reports (AE-5 - 2017-0303964 and AE6 -
2017-0303965). Some details are
clarified. The original filled AE5 and AE6 reports are also attached.

Kind
regards,
Maia

-----Original Message-----

From: Naira Romanova

To: 'Maia Nikoleishvili'

Date: Mon, 13 Nov 2017 15:15:42 +0400

Subject: RE: FW: Sovaldi AE report from Armenia

Dear Maia,

I in response to your request from 02.11.2017 on

AEs
clarifications, I would like to provide answers to A5 and A6 reports:

Concerning A5 report

The treatment start date is changed it was
written on report
02.07.2017 but should be 08.06.2017. Patient started treatment on
08.06.2017, from
31.06.2017 to 13.07.2017  treatment was stopped  because of
patients condition.
Treatment restarted on 13.07.2017 again. On 31.08.2017 patient was tested
and
the results shown HCV negative but because of liver condition and
decomposition
treatment was stopped. Patient was later hospitalized and died on
12.08.2017.
HC  Treating doctor  got aware about the patient death several
days after the
death.

Concerning A6 report

Patient started treatment on 14.06 and was on
treatment for 3
months without stopping the medication intake.

On 27.08..2017 doctor got aware that patient
died some days ago because
of hemodialysis complication (concomitant disease from 2012).

And the A3 report clarification was sent to you
on Friday.

The other rest of requested AE clarifications
doctor will
provide during this week. As soon as I get the information will send them to
you.

Kind regards,

Naira