Table 3

Serious adverse events (SAEs) occurring after surgery during the study period

System (n subjects)EventN eventsTiming of SAE start (Days postprocedure)
Infections (n=5)Sepsis222, 241
Gastroenteritis1108
Lower respiratory tract infection12
Urinary tract infection1118
Viral infection1234
Central nervous system (n=5)Headache2214, 1
Carotid stenosis10
Hypertonia11
Ischaemic Stroke11
Partial seizure122
Gastrointestinal (n=1)Vomiting12
Procedural (n=1)Subdural haemorrhage125
Immunological (n=1)HLA positivity133
Psychiatric (n=1)Suicide1342
Respiratory (n=1)Aspiration pneumonia1120
  • HLA, signifies human leucocyte antigen.