X hits on this document

458 views

0 shares

0 downloads

0 comments

43 / 170

14

independent data monitoring committee. The DMC periodically reviewed the

15

accumulating Saxagliptin safety data from the six pivotal phase 3 studies. The DMC has

16

allowed all studies under its review to continue at all doses and has not required any

17

study modifications. The Saxagliptin safety database was studied using complementary

18

populations, analyzed at different time points to enhance detection of potential safety

19

signals. Study level analyses enabled evaluation of Saxagliptin administered under

20

different treatment conditions. The placebo controlled pool population allowed for

21

integrated analysis of small numerical imbalances seen within the five placebo controlled

22

pivotal phase 3 studies.

4

and laboratory parameter review. These measures were complemented by a program to

5

collect supplemental data for events of special interests. Events were identified as being

6

of special interest based on findings observed in the Saxagliptin non-clinical program, in

7

the phase 1 and 2b programs at higher doses, safety related concerns reported for other

8

DPP-4 inhibitors, and theoretical considerations related to the mechanism of action of

9

DPP-4 inhibitors. Monitoring activities included ongoing identification of events and use

10

of supplemental case report forms to gather additional information on the following types

11

of events; skin lesions, selected infections, decreased lymphocytes or platelet counts, and

12

localized edema.

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

13

At the start of the phase 3 clinical development program we established an

1

worked with FDA to ensure that the development program provided adequate exposure

2

for each of the intended Saxagliptin indications.

23

24

The phase 2b/3 pool population incorporated the controlled experience of

all eight phase 2b/3 studies enabling comprehensive evaluation of relatively infrequent

3

The safety of Saxagliptin was evaluated through standard adverse event

42

Document info
Document views458
Page views458
Page last viewedTue Dec 06 08:56:00 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments