Table 3

Associations between change in systolic BP from baseline to day 2 and clinical outcomes

Overall	>15% decrease		5%–15% decrease		5% decrease to 5% increase	>5% increase
Overall	cOR/OR/HR/MD (95% CI)	P value	cOR/OR/HR/MD (95% CI)	P value	(Reference)	cOR/OR/HR/MD (95% CI)	P value
N (%)	994		601		401	230
Baseline systolic BP, mm Hg, mean (SD)	188.1 (24.6)		167.8 (20.5)		157.8 (20.2)	143.5 (19.9)
Haematoma
Change in volume from baseline to 24 hours*, mL	−0.58 (-3.07, 1.92)	1.00	−0.27 (-2.73, 2.19)	1.00	0	−0.73 (-2.46, 3.92)	1.00
Haematoma expansion (%)	0.95 (0.69, 1.29)	0.72	0.83 (0.61, 1.13)	0.23	1	1.04 (0.71, 1.54)	0.83
Day 2
Death (%)	0.58 (0.24, 1.42)	0.24	0.48 (0.18, 1.25)	0.13	1	1.54 (0.60, 3.94)	0.37
SAEs (%)	1.22 (0.91, 1.64)	0.18	0.97 (0.72, 1.30)	0.83	1	1.34 (0.93, 1.93)	0.12
Day 7
Death (%)	0.71 (0.42, 1.19)	0.19	0.43 (0.24, 0.76)	0.003	1	1.78 (1.02, 3.12)	0.044
SAEs (%)	1.26 (0.95, 1.68)	0.11	1.05 (0.79, 1.40)	0.72	1	1.55 (1.08, 2.22)	0.018
Day 90
Primary outcome
mRS [/6]	1.07 (0.84, 1.35)	0.59	1.00 (0.79, 1.27)	0.97	1	1.34 (0.99, 1.81)	0.063
Death (%)	0.79 (0.59, 1.06)	0.11	0.83 (0.62, 1.11)	0.21	1	1.08 (0.77, 1.53)	0.66
SAEs (%)	1.21 (0.91, 1.62)	0.19	1.03 (0.78, 1.37)	0.82	1	1.35 (0.94, 1.95)	0.11
Tranexamic acid, N (%)	491		293		210	122
Baseline systolic BP, mm Hg, mean (SD)	187.6 (24.8)		166.6 (20.5)		158 (21.7)	142.2 (19.2)
Haematoma
Change in volume from baseline to 24 hours*, mL	−1.81 (-5.21, 1.58)	0.95	−2.15 (-5.51, 1.21)	0.55	0	−0.22 (-4.48, 4.03)	1.00
Haematoma expansion (%)	0.99 (0.63, 1.55)	0.95	0.91 (0.58, 1.43)	0.68	1	1.01 (0.58, 1.77)	0.97
Day 2
Death (%)	0.32 (0.09, 1.08)	0.07	0.35 (0.09, 1.46)	0.15	1	2.13 (0.62, 7.31)	0.23
SAEs (%)	1.24 (0.82, 1.87)	0.32	0.97 (0.64, 1.47)	0.88	1	1.13 (0.67, 1.89)	0.65
Day 7
Death (%)	0.41 (0.20, 0.85)	0.017	0.37 (0.16, 0.82)	0.015	1	1.87 (0.85, 4.12)	0.12
SAEs (%)	1.19 (0.80, 1.77)	0.40	0.83 (0.56, 1.24)	0.37	1	1.18 (0.72, 1.94)	0.52
Day 90
Primary outcome
mRS [/6]	0.95 (0.68, 1.32)	0.76	1.08 (0.78, 1.50)	0.64	1	1.35 (0.89, 2.06)	0.16
Death (%)	0.62 (0.42, 0.93)	0.022	0.75 (0.49, 1.13)	0.17	1	0.99 (0.61, 1.60)	0.97
SAEs (%)	1.09 (0.73, 1.63)	0.67	0.84 (0.56, 1.24)	0.37	1	0.89 (0.54, 1.46)	0.64
Placebo, N (%)	503		308		191	108
Baseline systolic BP, mm Hg, mean (SD)	188.6 (24.3)		168.9 (20.5)		157.7 (18.4)	144.9 (20.7)
Haematoma
Change in volume from baseline to 24 hours*, mL	0.60 (-3.07, 4.28)	1.00	1.42 (-2.19, 5.03)	1.00	0	1.49 (-3.33, 6.32)	1.00
Haematoma expansion (%)	0.92 (0.59, 1.42)	0.69	0.76 (0.49, 1.16)	0.20	1	1.05 (0.60, 1.83)	0.87
Day 2
Death (%)	1.35 (0.34, 5.30)	0.67	0.66 (0.16, 2.77)	0.57	1	1.04 (0.21, 5.22)	0.96
SAEs (%)	1.21 (0.79, 1.84)	0.38	0.97 (0.64, 1.46)	0.87	1	1.54 (0.91, 2.61)	0.11
Day 7
Death (%)	1.21 (0.57, 2.58)	0.62	0.52 (0.23, 1.18)	0.12	1	1.78 (0.78, 4.06)	0.17
SAEs (%)	1.36 (0.90, 2.06)	0.15	1.33 (0.88, 2.00)	0.17	1	1.99 (1.17, 3.39)	0.011
Day 90
Primary outcome
mRS [/6]	1.18 (0.84, 1.65)	0.35	0.91 (0.65, 1.27)	0.56	1	1.32 (0.85, 2.07)	0.22
Death (%)	0.98 (0.64, 1.52)	0.94	0.81 (0.52, 1.26)	0.34	1	0.98 (0.58, 1.64)	0.93
SAEs (%)	1.37 (0.90, 2.08)	0.14	1.28 (0.85, 1.93)	0.24	1	2.14 (1.24, 3.70)	0.007

Ordinal, binary, multiple linear or Cox regression with adjustment for baseline prognostic factors. The 5% decrease to 5% increase group is the reference group for comparisons.
Bold p-values indicate <0.05
*Adjusted for baseline haematoma volume.
BP, blood pressure; cOR, common OR; MD, mean difference; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; SAEs, serious adverse events.