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Table 6 Additional sensitivity analysis comparing use of 1 or 2 placebo periods for the primary analysis

From: The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study

Placebo-corrected adjusted means and 90% CIs for the mean QTcN change from baseline 1−4 hours after dosing analysed using two different ANCOVA models

ANCOVA model

25 mg empagliflozin Difference from placebo, ms

200 mg empagliflozin Difference from placebo, ms

 

Mean (SE)

90% CI

Mean (SE)

90% CI

Primary analysis model with placebo period 1 only

0.2 (0.9)

(-1.4, 1.8)

-0.5 (0.8)

(-1.8, 0.8)

Primary analysis model with placebo period 2 only

0.6 (1.0)

(-1.2, 2.4)

0.1 (0.8)

(-1.4, 1.5)

  1. Data from full analysis set (n=30). ANCOVA, analysis of covariance; CI, confidence interval; QTcN, population heart rate-corrected QT interval.