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The incidence rate ratio for primary MACE for the phase 2b/phase 3 pool population is

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shown at the top of the slide. The incidence rate ratio for each individual study is shown

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below. The point estimate and the 95% of confidence intervals are shown relative to a

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vertical line drawn at unity. Data to the left of the vertical line indicate the Saxagliptin is

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better, data to the right of the vertical line indicate the control is better.

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weighted Kaplan Meier estimate for cumulative proportion. The X-axis represents time

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measured in weeks, the Y-axis represents the cumulative percent of patients with primary

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MACE. The data in this figure do not indicate increased risk for primary MACE for

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Saxagliptin treatment patients during either the short-term or the long-term phase of our

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studies.

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the incidence rate ratio was 0.83. As expected, there was some variability in the point

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estimate for each individual trial, but there was considerable overlap in the confidence

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intervals indicating consistency in results for the trials in the phase 2b/phase 3 program.

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Our statistical analysis plan specified that we would analyze primary MACE in sub

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groups of patients with clinical evidence of cardiovascular disease and with

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cardiovascular risk factors.

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The next slide summarizes the incidence rate ratio for primary MACE.

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In the pooled analysis the upper bound or the 95% confidence interval for

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on the results of a primary MACE. However, as stated previously, the results for the

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FDA defined endpoint of custom MACE would be nearly identical to the results for

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primary MACE.

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Our analysis plan specified sub groups of patients who are believed to be

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at increased risk of CV events based on epidemiologic data. Those sub groups included

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This slide depicts the time to onset of first primary MACE using a

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