Fatal and non-fatal events within 14 days after early, intensive mobilization post stroke.

Objective This tertiary analysis from AVERT examined fatal and non-fatal Serious Adverse Events (SAEs) at 14 days. Method AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced Results 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (IQR 63–80) and NIHSS 7 (IQR 4–12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted Odds Ratio of 1.76 (95% CI 1.06–2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral haemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in non-fatal SAEs found. Conclusion While the overall case fatality at 14 days post-stroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose, intensive training compared to usual care. Stroke progression was more common in VEM. Classification of evidence This study provides Class I evidence that very early mobilization increases mortality at 14 days post stroke. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12606000185561.