of events in the broad SMQ analysis, I am now showing the preferred terms under the
SOC of investigations. It is the term blood CPK increased that clearly drives the number
of events seen on the broad SMQ analysis with the rates ranging from 1.5% in the
comparator group to 2.2% in the 5-milligram group. Just as a reminder, increased CPK
was not included in the “Custom MACE” endpoint. The FDA statistician, Ms. Mele, will
now present the statistical analyses of these MACE events.
MACE” endpoint. I will now present the incidents of “MACE” events using the broad
SMQ endpoint. Again, overall event rates were relatively low. In the short-term period,
1.4 to 1.9% in the Saxagliptin groups versus 2% in the comparator. In the short-term plus
long-term period, rates were similar across all groups, all around 3%. Again the same
data with the Saxagliptin groups pooled showing you an incidence rate of 1.7% versus
2% in the short-term period and similar rates of 3 and 3.2% in the combined short-term
plus long-term periods. When these events are then broken down by SOC for the short-
term period; it is clear that one SOC investigations which I have highlighted, contains
most of the events with incidence rates of 1.1 to 1.6%.
Thank you. Thank you, Dr. Lowy. Now you have seen the MACE results
from the company and our results do not differ from those results in any notable way. So
To illustrate the point that the SOC investigations, comprises the majority
was observed only once in the 2.5 milligram, 5 milligram and comparator groups,
while hemorrhagic stroke was seen once in the 10-milligram group.
JOY MELE, M.S.
in addition to showing you these results again with some other details, I will describe to
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
So far, I have discussed the incidences of events under the “Custom