Baseline Characteristics Module
The Baseline Characteristics Module provides demographic and baseline characteristics information for participants in a clinical trial. This module includes data such as population descriptions and the types of units analyzed, helping researchers understand the baseline characteristics of study participants.
Baseline Characteristics Module path is as follows:
Study -> Results Section -> Baseline Characteristics Module
Baseline Characteristics Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
NCT ID:
NCT01860703
Population Description:
Fifty subjects were enrolled in order to have at least 33 subjects complete the study. The sample size calculations were based on the ICH E14 Guidance which defines a negative TQT study as one "in which the upper bound of the 95% one-sided CI for the largest time-matched mean effect of the drug on the QTc interval excludes 10 msec."
Study:
NCT01860703
Study Brief:
Results Section:
NCT01860703