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 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
NCT ID:
NCT03491969
Population Description:
The primary efficacy endpoints were analyzed using the full analysis set (FAS), which followed the Intent-to-Treat (ITT) principle. Inclusion in the FAS required that participants receive the investigational drug for a minimum of 1 month. 300 patients were randomized in a 1:1 ratio to receive either ALA or a matching placebo. In the ALA group, 12 patients were excluded from the primary analysis. In the placebo group, 11 participants were excluded.
Study:
NCT03491969
Study Brief:
Results Section:
NCT03491969