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Table 3 Primary Outcome and Bleeding Events

From: Clinically stable covid-19 patients presenting to acute unscheduled episodic care venues have increased risk of hospitalization: secondary analysis of a randomized control trial

Characteristic

All Randomized

(Nā€‰=ā€‰533)

Minimal Contact enrollment

(Nā€‰=ā€‰306)

Acute Episodic Care enrollment

(Nā€‰=ā€‰227)

p-value#

Adjudicated primary outcomesā€”no. (%)

Ā Ā Ā Ā 

ā€ƒComposite primary endpoint

20 (3.8)

2 (0.7)

18 (7.9)

<ā€‰0.001

ā€ƒCardio-pulmonary hospitalizations

20 (3.8)

2 (0.7)

18 (7.9)

<ā€‰0.001

ā€ƒCOVID-19 associated pneumonia

20 (3.8)

2 (0.7)

18 (7.9)

<ā€‰0.001

ā€ƒDeep vein thrombosis or pulmonary embolism

1 (0.2)

0 (0.0)

1 (0.4)

0.43

ā€ƒMyocardial infarction, stroke or other arterial embolism

0 (0.0)

0 (0.0)

0 (0.0)

-

ā€ƒDeath

1 (0.2)

0 (0.0)

1 (0.4)

0.43

Suspected Hemorrhagic Eventsā€”no. (%)*

Ā Ā Ā Ā 

ā€ƒMajor bleeding

0 (0.0)

0 (0.0)

0 (0.0)

-

ā€ƒClinically relevant non-major bleeding

13 (2.4)

6 (2.0)

7 (3.1)

0.41

ā€ƒMinor bleeding

17 (3.2)

8 (2.6)

9 (4.0)

0.46

Adjudicated Hemorrhagic Eventsā€”no. (%)

Ā Ā Ā Ā 

ā€ƒMajor bleeding

0 (0.0)

0 (0.0)

0 (0.0)

-

ā€ƒClinically relevant non-major bleeding

5 (0.9)

2 (0.7)

3 (1.3)

0.66

  1. *Suspected major and clinically relevant non-major bleeding events were reported by the trial medical monitor, and minor bleeding events were identified through follow-up with the research pharmacists. Major and clinically relevant non-major bleeding events were adjudicated by the Clinical Events Committee; minor bleeding events were not adjudicated.
  2. # p-values comparing outcome risk in the Minimal Contact enrollment to that in the Acute Episodic Care enrollment group are based on Fisherā€™s exact tests.