PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke—statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment

Table 4 Secondary outcome assessment at 90 days

	Analysis	Paracetamol	Control	OR (95% CI)	Metoclopramide	Control	OR (95% CI)	Ceftriaxone	Control	OR (95% CI)
mRS, median
Ischaemic stroke	aOLR	Median [IQR]	Median [IQR]	aOR (95% CI)	Median [IQR]	Median [IQR]	aOR (95% CI)	Median [IQR]	Median [IQR]	aOR (95% CI)
Intracerebral haemorrhage	aOLR	Median [IQR]	Median [IQR]	aOR (95% CI)	Median [IQR]	Median [IQR]	aOR (95% CI)	Median [IQR]	Median [IQR]	aOR (95% CI)
Other diagnosis	aOLR	Median [IQR]	Median [IQR]	aOR (95% CI)	Median [IQR]	Median [IQR]	aOR (95% CI)	Median [IQR]	Median [IQR]	aOR (95% CI)
Mortality	aCPHR	n (%)	n (%)	aHR (95% CI)	n (%)	n (%)	aHR (95% CI)	n (%)	n (%)	aHR (95% CI)
mRS, unfavourable outcome	aBLR	n (%)	n (%)	aOR (95% CI)	n (%)	n (%)	aOR (95% CI)	n (%)	n (%)	aOR (95% CI)
Patient location	aOLR			aOR (95% CI)			aOR (95% CI)			aOR (95% CI)
Hospital		n (%)	n (%)		n (%)	n (%)		n (%)	n (%)
Rehabilitation service		n (%)	n (%)		n (%)	n (%)		n (%)	n (%)
Nursing home		n (%)	n (%)		n (%)	n (%)		n (%)	n (%)
Home		n (%)	n (%)		n (%)	n (%)		n (%)	n (%)
Home time (no. of days)	aMLR	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)
Questionnaires
Barthel Index	aMLR	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)
MoCA	aMLR	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)
EQ-5D-5L	aMLR	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)
EQ-VAS	aMLR	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)	Mean (SD)	Mean (SD)	aDIM (95% CI)

Data are n (%) or median [IQR]. aDIM adjusted difference in means, aOR adjusted odds ratio, aHR adjusted hazards ratio, mRS modified Rankin Scale, MoCA Montreal Cognitive Assessment, EQ-5D-5L EuroQol 5D-5L, EQ-VAS EuroQol-visual analogue scale. Comparison by adjusted ordinal logistic regression (aOLR), cox proportional hazards regression (aCPHR), or multiple linear regression (aMLR)

ISSN: 1745-6215