129 7 DELIRIUM | PART THREE (Figure 2). Exploratory analysis did not demonstrate any significant benefit of olanzapine in DRR for hyperactive, hypoactive, or mixed subtypes (Table 2). Futility analysis was conducted, and at this time, the conditional power was 8.6%. As the conditional power was lower than the threshold for futility, this analysis indicated that this study was unlikely to reach the predefined efficacy criteria. Therefore, recruitment was terminated prematurely (June 15, 2016). Table 2. Delirium Resolution Rate (DRR) for deliriummotor subtypes (intention-to-treat population). DRR Motor subtype Olanzapine (n= 49) Haloperidol (n= 49) OR, 95% CI (p valuea) Hyperactive, n Responders (n, (%)) 16 8 (50) 20 13 (65) 0.5, 0.1-2.1 (0.50) Hypoactive, n Responders, n, (%) 10 3 (30) 17 11 (65) 0.2, 0.04-1.5 (0.12) Mixed, n Responders, n, (%) 21 10 (47) 12 4 (33) 1.8, 0.4-7.9 (0.49) Unknown, 2 0 Abbreviations: CI, confidence interval; OR, odds ratio ap two-sided chi-square test (olanzapine vs. haloperidol). Safety TRAEs were in line with previous data [9], with TRAEs of any grade occurring in 13 patients (26.5%) in the olanzapine arm and 16 patients (32.7%) in the haloperidol arm (Table 3). Grade ≥3 TRAEs (all leading to drug discontinuation) were reported in 5 patients (10.2%) in the olanzapine arm, and 10 patients (20.4%) in the haloperidol arm (OR, 0.4; 95% CI, 0.1-1.4; p = .16). Sedation was the most reported grade ≥3 TRAE, in 5 (10.2%) and 7 (14.3%) patients in the olanzapine and haloperidol arms, respectively. Grade ≥3 EPS (including tremors and muscle stiffness) occurred in two patients in the haloperidol arm; there was no reported grade ≥3 EPS in the olanzapine arm. One patient in the haloperidol arm experienced QTc prolongation (>500 msec), and none in the olanzapine arm. All grade ≥3 TRAEs occurred on day 1 or 2. There were no treatment-related deaths in both treatment arms.
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