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Clinical adverse experience summary |
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| Sitagliptin 100 mg n (%) (N = 3415) |
Non-Exposed n (%) (N = 2724) |
Difference in Sitagliptin and Non-Exposed % (95% CI)* |
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| With one or more adverse experiences |
2150 (63.0) |
1711 (62.8) |
0.1 (-2.3, 2.6) |
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| With drug-related adverse experiences† |
440 (12.9) |
483 (17.7) |
-4.8 (-6.7, -3.0) |
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| With serious adverse experiences |
230 (6.7) |
184 (6.8) |
-0.0 (-1.3, 1.2) |
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| With serious drug-related adverse experiences† |
8 (0.2) |
8 (0.3) |
-0.1 (-0.4, 0.2) |
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| Who died |
11 (0.3) |
16 (0.6) |
-0.3 (-0.7, 0.1) |
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| Discontinued due to adverse experiences |
106 (3.1) |
101 (3.7) |
-0.6 (-1.5, 0.3) |
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| Discontinued due to drug-related adverse experiences |
30 (0.9) |
40 (1.5) |
-0.6 (-1.2, -0.1) |
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| Discontinued due to serious adverse experiences |
51 (1.5) |
47 (1.7) |
-0.2 (-0.9, 0.4) |
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| Discontinued due to serious drug-related adverse experiences |
4 (0.1) |
4 (0.1) |
-0.0 (-0.3, 0.2) |
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CI = confidence interval *Positive differences indicate that the incidence rate for the sitagliptin group is higher than the incidence rate for the non-exposed group. "0.0" and "-0.0" represent rounding for values that are slightly greater and slightly less than zero, respectively. †Determined by the investigator to be possibly, probably, or definitely drug-related. | |||
Williams-Herman et al. BMC Endocrine Disorders 2008 8:14 doi:10.1186/1472-6823-8-14 |
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