Table 3:

Safety outcomes

	Study stop threshold	MISTIE (n=255)	Medical (n=251)	p value
Died within 7 days	10%	2 (0·8%)	10 (4·0%)	0·018
Died within 30 days	60%	24 (9·4%)	37 (14·7%)	0·066
Died within 180 days	NA	39 (15·3%)	57 (22·7%)	0·033
Bacterial brain infection within 30 days	15%	2 (0·8%)	0	0·160
Symptomatic brain bleeds within 72 h after last dose*	25%	6 (2·4%)	3 (1·2%)	0·325
Asymptomatic brain bleeds within 72 h after last dose*	NA	81 (31·8%)	21 (8·4%)	<0·0001
Number of serious adverse events within 30 days	NA	126	142	0·012

Data are n, or n (%). NA=not applicable.

^*For patients in the MISTIE group who achieved the endpoint before alteplase dosing and for patients in the standard medical care group, this was calculated as the corresponding median time from randomisation. Safety analyses were done for the full randomised cohort (n=506), including the seven patients randomised in error.