APEX-STROKE CALM-ICH Domain

modified Rankin scale (mRS) scores

The modified Rankin Scale (mRS) is a 7-point ordinal scale assessing global disability and functional dependence after stroke, ranging from 0 (no symptoms) to 6 (death). Intermediate scores indicate increasing severity: 1, no significant disability; 2, slight disability; 3, moderate disability; 4, moderately severe disability; 5, severe disability. The primary analysis will use the ordinal distribution of scores across all 7 levels; lower scores indicate better functional outcome.

Hematoma volume

Hematoma volume will be measured on brain CT/MRI in mL using semi-automated volumetric software.

Hematoma Expansion at 24 Hours

Hematoma expansion is defined as an absolute increase of ≥6 mL or a relative increase of ≥33% in hematoma volume between baseline and the 24-hour scan.

NIHSS score

The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 (no neurological deficit) to 42 (most severe deficit), assessing consciousness, gaze, visual fields, motor and sensory function, language, and neglect. Higher scores indicate more severe neurological impairment.

Mortality

All-cause mortality will be reported as the number and proportion of participants who died from any cause by 180 days after randomization.

Incidence of Serious Adverse Events

Incidence of serious adverse events (SAEs) occurring during the safety follow-up period. An SAE is defined as an adverse event resulting in death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that, based on appropriate medical judgment, may jeopardize the participant or require medical or surgical intervention to prevent one of these outcomes.

Incidence of Adverse Events of Special Interest

Incidence of adverse events of special interest (AESIs) during the safety follow-up period. AESIs include whole-blood mercury or arsenic concentrations ≥2 times the upper limit of normal (ULN), liver function abnormalities defined as alanine aminotransferase or aspartate aminotransferase \>3 times the ULN, and renal function abnormalities defined as serum creatinine ≥2 mg/dL.