Statement of Charles N. Oster, M.D.

1992; I still had not seen Dr. McCarthy's or LTC Brundage's
analyses of the data.
I went to Ward 11 and looked at the record and found the
following information: The patient had enrolled in the Phase IIA
study in November 1990 at which time he was a Walter Reed (WR)
stage 2 and began the study 21 January 1991. In September 1991 he
was changed to a WR stage 3 and again inL bruary 19 2 staged as a
3. In April 1992 the patient was seen bye ho found and
confirmed thrush. He documented these findings in the patient's
medical record and kept a copy of his notes in the ID convenience
file. Copies were forwarded to Ward 11 for inclusion in the
patient's study record and were placed in the first of two volumes
of his study record.
On 10 June 1992, he returned for four monb interyal staging
as called for in the protocol and was seen by 1 At that
time she only had the econd volumepf the patients study record
(which did not contain(!nots) and in the absnce of
thrush staged him a WR A study nurpe noted
this and brought it to( ttention. He corrected the
stage to WR 5 and signedit but failed to date the correction. It
was apparently prior to the completion of the Wyeth data forms on
26 June 1992 because the patient is listed as a WR 5. In a
subsequent visit on 29 September 1992 he was again staged as a WR
5.
In my review of these events, which I documented in a MFR
dated 11 November 1992, I concluded that the situation was handled
correctly by all involved but that there is still some doubt about
the accuracy of the staging of this patient. The issue is that he
developed thrush while experiencing an exanthematous reaction to
trimethoprim/sulfamethoxazole and this raises the question of cases
like this if thrush requires staging as a WR 5. A pr.cise
definition needs to be written in the protocol handbook.I

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