Table 2.

Adjudicated Safety Events, with Thresholds for Randomized Medical and MIS+rt-PA with 95%CI.

Event	Study- stop threshold	Medical (N=42)		MIS+rt-PA (N=54)		p-value
		no (%)	95% CI	no (%)	95% CI
Died within 0–7 days	10%	0 (0%)	(0%, 8.4%)	1 (1.9%)	(0.1%, 9.9%)	0.562
Died Within 0–30 Days	70%	4 (9.5%)	(2.7%, 22.6%)	8 (14.8%)	(6.6%, 27.1%)	0.542
Bacterial Brain Infection 0–30 Days*	15%	1 (2.4%)	(0.1%, 12.6%)	0 (0%)	(0%, 6.6%)	0.438
Symptomatic Bleed 72 h post last dose†	35%	1 (2.4%)	(0.1%, 12.6%)	5 (9.3%)	(3.1%, 20.3%)	0.226
Asymptomatic Bleed 72 h post last dose‡	n/a	3 (7.1%)	(1.5%, 19.5%)	12 (22.2%)	(12%, 35.6%)	0.051
Symptomatic or Asymptomatic Bleed 72 h post last dose§	n/a	4 (9.5%)	(2.7%, 22.6%)	15 (27.8%)	(16.4%, 41.6%)	0.038

^*Bacterial brain infection criteria included cultured organism identification in the presence of fever, relevant lab values, and associated clinical symptoms.

^†Symptomatic bleeding criteria included radiographic evidence of an increase in clot volume (>5ml increase) associated with a decrease in the GCS motor scale score of more than two points sustained for a minimum of eight hours or associated clinical symptoms in the opinion of the site investigator.

^‡Asymptomatic brain bleeding was reported and adjudicated to include those events where clot size increase (>5ml increase) was confirmed by the core lab on volumetric measurement of the CT scan by comparison to the most previous CT scan, but where no alteration of GCS was noted.

^§Symptomatic or asymptomatic bleed is the total of all adjudicated bleeding events.