Primary outcome and secondary outcomes
| Placebo | ICH-2 | ICH-1 | Differences among groups | |
| P value | ||||
| Primary outcome: the incidence of haematoma enlargement at 24 hours and at day 14 | ||||
| At 24 hours | 8/104 (7.8) | 8/108 (7.5) | 13/107 (12.3) | 0.409 |
| On days 10–14 | 1/92 (1.1) | 3/97 (3.1) | 1/91 (1.1) | 0.625 |
| Haemorrhage volumes (mL) at baseline and follow-up | ||||
| At baseline | 9.82±7.45 | 11.56±9.67 | 11.57±11.55 | 0.284 |
| At 24 hours | 9.71±6.94 | 11.97±10.02 | 14.44±19.33 | 0.313 |
| Percent increase from baseline-means% (95% CI) | −14.1 (4.5–32.7) | 3.4 (0.2–6.5) | 41 (9.4–91.4) | 0.22 |
| Millilitres of increase from baseline | −0.13±1.41 | 0.22±2.24 | 3.13±16.10 | 0.168 |
| Secondary outcomes: | ||||
| NIHSS* at 3 months | 3.58±5.32 | 3.58±5.32 | 3.58±5.32 | 0.475 |
| Mortality at 3 months | 4/104 (3.8) | 1/108 (0.9) | 3/107 (2.8) | 0.328 |
| Poor prognosis (mRS≥5) | 7/99 (7.1) | 5/105 (4.8) | 6/100 (6.0) | 0.783 |
| Total TEAEs | 6/104 (5.8) | 3/108 (2.8) | 13/107 (12.1) | 0.022 |
The values are expressed as n/N(%) within group or the means±SD;
*Denotes the number of patients at 3 months: 104 in the placebo group, 107 in the ICH-2 group and 105 in the ICH-1 group.
ICH denotes intracerebral haemorrhage; NIHSS, National Institutes of Health Stroke Scale; TEAEs, treatment-emergent adverse events.