Table 3.
System (n subjects) | Event | N events | Timing of SAE start (Days postprocedure) |
Infections (n=5) | Sepsis | 2 | 22, 241 |
Gastroenteritis | 1 | 108 | |
Lower respiratory tract infection | 1 | 2 | |
Urinary tract infection | 1 | 118 | |
Viral infection | 1 | 234 | |
Central nervous system (n=5) | Headache | 2 | 214, 1 |
Carotid stenosis | 1 | 0 | |
Hypertonia | 1 | 1 | |
Ischaemic Stroke | 1 | 1 | |
Partial seizure | 1 | 22 | |
Gastrointestinal (n=1) | Vomiting | 1 | 2 |
Procedural (n=1) | Subdural haemorrhage | 1 | 25 |
Immunological (n=1) | HLA positivity | 1 | 33 |
Psychiatric (n=1) | Suicide | 1 | 342 |
Respiratory (n=1) | Aspiration pneumonia | 1 | 120 |
HLA, signifies human leucocyte antigen.