Figure 1.. Association of Treatment Group With Day 2 Maximum Predose QTc Interval In analyses adjusting for prerandomization QTc interval, maximum pre-dose QTc interval on day 1, age at enrollment, sex, body mass index (BMI) at admission, and Sequential Organ Failure Assessment (SOFA) score at randomization, there was no association between treatment and day 2 maximum predose QTc, with haloperidol vs saline placebo and ziprasidone vs placebo. The quantitative variable values selected for the ORs represent the 25th and 75th percentile of the distribution of the variable. This common method is useful when examining an association that may be nonlinear and often provides more intuitive results than one that computes an OR from a single-unit change in the exposure variable.
Figure 2.. Maximum Predose QTc Interval on Study Day 2 Mean (SD) day 2 maximum predose QTc intervals were 454.6 (40.6) for the placebo group, 455.9 (44.0) for the haloperidol group, and 454.7 (44.8) for the ziprasidone group, and did not differ significantly between groups. Center lines indicate the median; upper and lower bounds of the boxes indicate 25th and 75th percentiles; vertical lines indicate 1.5 times the IQR from each box end; and dots indicate data distribution.
Figure 3.. Median Predose QTc Intervals The median of the mean predose QTc interval for all days during the intervention period was 444.0 (IQR, 420.5-470.0) ms in the haloperidol group, 445.0 (IQR, 419.5-465.0) ms in the ziprasidone group, and 442.5 (IQR, 421.4-469.4) ms in the placebo group and showed no discernable trend over time. Study days are considered as time from randomization to treatment group. The sample size provided for each day represents the number of patients who were included in the analysis for that day to estimate the average predose QTc interval.
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ClinicalTrials.gov Identifier: NCT01211522.
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Stollings et al. (2024) studied this question.
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