'Seroquel' is a trademark, property of astrazeneca limited. Mdatabprs is a pooled dataset of 12 trials, each of which had either BPRS or P ANSS as an endpoint. The analyses performed compare Seroquel separately with each of placebo; haloperidol; chlorpromazine; Risperidone and 'other typicals'
'Seroquel' is a trademark, property of astrazeneca limited. Mdatabprs is a pooled dataset of 12 trials, each of which had either BPRS or P ANSS as an endpoint. The analyses performed compare Seroquel separately with each of placebo; haloperidol; chlorpromazine; Risperidone and 'other typicals'
'Seroquel' is a trademark, property of astrazeneca limited. Mdatabprs is a pooled dataset of 12 trials, each of which had either BPRS or P ANSS as an endpoint. The analyses performed compare Seroquel separately with each of placebo; haloperidol; chlorpromazine; Risperidone and 'other typicals'
EXHIBIT 2AstraZeneca Pharmaceuticals
Seroquel™
(Quetiapine)
Commercial Support Team - Technical Document (TD004)
BPRS meta-analysis,
[This document is a confidential communication. Acceptance of it constitutes an
| agreement signed by the recipient that no unpublished information contained herein
|will be published or disclosed without prior written approval of the sponsor.
| Seroquer is a trademark, property of AstraZeneca Limited.
“Beraquel Technical Document (1004) Date Printed 7872000,
‘Ahr Rob Hemmings
AZISER 0747285Request From:
[Date Requested:
‘Statistician/Statistical Programmer Responsible: Rob Hemmings / Karen
Melvin
1 Source of Data
Data for these analyses comes from mdata bprs (a dataset stored in the CDE within the
CST directory). This is a pooled dataset of 12 trials, each of which had either BPRS
or PANSS as an endpoint. These trials represent all available data on BPRS scores,
from the Seroquel clinical tril program.
‘The creation of this dataset (handling of missing data, timing of endpoint etc.) is
described in a document produced by Karen Melvin. This document is held in
8:\45077files\cst\dataset creation. doc.
2 Design of Trials/ Analysis Methods
2.1 Study Design
‘Ten studies were selected to be used in this analysis, these are listed below:
507711/0004, 50771./0006, 204636/0007, 204636/0008, 5071/0013, 50771L/0014,
'50771L/0050, 5077IL/0052, 50771L/0053, 50771L/0054.
‘The two trials omitted from the original dataset were trials 5077HL/0012 and
507TIL/0015. The former because there was no internal comparator (making model
fitting difficult) and the latter because of significantly different entry criteria,
In of these 10 trials, the BPRS questionnaire was used as an endpoint in the trial. In
the remaining 5 trials, BPRS scores have been derived from the PANSS questionnaire
which was atrial endpoint.
Comparators
‘The analyses performed compare Seroquel separately with each of placebo;
Haloperidol; Chlorpromazine; Risperidone and ‘other typicals’ (defined as either
Haloperidol or Chlorpromazine). Four of the trials contained comparative data against
placebo; 4 against Haloperidol; 2 against Chlorpromazine; 1 against Risperidone and 6
against ‘other typical’.
‘Seroquel Techical Docarnent (7004) at into 7872000
‘Author: Rob Hemmings
AZISER 0747288
Letter From Leigh Turner To Sen. Terri Bonoff and Other Legislators Regarding Psychiatric Clinical Trials and The Recruitment of Involuntarily Held Patients