Table 3.

Comparison of Adverse Events between de-PMD and Usual Care Groups

	de-PMD (n=99)	Usual Care (n=101)	P-value
Patients with Serious Adverse Event	27 (27.3)	22 (21.8)	0.413
Total Number of Serious Adverse Events	37	35
Event Type*
Death	11 (11.1)	8 (7.9)	0.478
QT prolongation	0 (0)	0 (0)	N/A
Cardiac Arrhythmias	1 (1.0)	1 (1.0)	1.000
Extra Pyramidal Symptoms	0 (0)	0 (0)	N/A
Neuroleptic Malignant Syndrome	0 (0)	0 (0.0)	N/A
Prolonged Hospitalization	5 (5.0)	2 (2.0)	0.277
Other	15 (15.2)	14 (13.9)	0.843
Relationship to Protocol
Event Definitely related	0 (0)	0 (0)	N/A
Event Probably related	0 (0)	0 (0)	N/A
Event Possibly related	0 (0)	0 (0)	N/A
Organ System
Central Nervous System	4 (4.0)	2 (2.0)	0.443
Cardiovascular	10 (10.1)	9 (8.9)	0.814
Respiratory	11 (11.1)	12 (11.9)	1.000
Gastrointestinal	3 (3.0)	3 (3.0)	1.000
Genitourinary	0 (0.0)	4 (4.0)	0.121
Skin	1 (1.0)	0 (0.0)	0.495
Hepatic	0 (0)	0 (0)	N/A
Hematologic	3 (3.0)	3 (3.0)	1.000
Endocrine	0 (0)	0 (0)	N/A
Musculoskeletal	1 (1.0)	1 (1.0)	1.000
Delirium-related complications
Inappropriate attempt to get out of bed, N (%)	8 (8.1)	5 (5.0)	0.407
Verbal agitation, N (%)	5 (5.0)	5 (5.0)	1.000
Fall, N (%)	2 (2.0)	0 (0.0)	0.246
Delayed Procedure, N (%)	0 (0.0)	0 (0.0)
Pulling Tubes, N (%)	9 (9.1)	2 (2.0)	0.033
Hospital Acquired Pressure Ulcers, N (%)	18 (18.2)	10 (10.0)	0.107

Data presented as N (%) unless otherwise specified

^*Event types are presented as number of patients with the event. A single patient may have more than one adverse event