Serious adverse events
Intravenous rtPA (IVT) | IVT+MT | |
---|---|---|
n | 32 | 33 |
No. with any SAE | 11 (34%) | 15 (45%) |
No. of SAEs reported | 15 | 21 |
Probably or definitely related to study procedures | 3 | 2 |
Fatal SAEs | 4 | 7 |
No. fatal SAEs <7 days after onset | 1 | 6 |
Fatal neurological events <7 days after onset | 1 | 4 |
Intracerebral haemorrhage events | ||
Any ICH | 3 | 3 |
SICH | 0 | 0 |
ICH events on CT | ||
HI1 or HI2 | 12 | 13 |
PH1 | 1 | 1 |
PH2 | 0 | 2 |
Non-ICH SAEs | 12 | 18 |
Anaemia | 0 | 1 |
MI/acute coronary syndrome | 2 | 1 |
Gingival bleeding | 1 | 0 |
Pneumonia | 4 | 5 |
Brain swelling | 2 | 4 |
Recurrent ischaemic stroke | 0 | 3 |
Neurological deterioration, not definitely ICH or swelling | 0 | 1 |
Other | 3 (CCF, UTI, psychiatric) | 3 (pulmonary embolism, osteoarthritis, UTI) |
CCF, congestive cardiac failure; HI1/HI2, haemorrhagic infarction types 1 or 2; ICH, intracerebral haemorrhage; IV, intravenous; MI, myocardial infarction; MT, mechanical thrombectomy; PH1/2, parenchymal haematoma types 1 or 2; rtPA, recombinant tissue plasminogen activator; SAE, serious adverse event; SICH, symptomatic intracerebral haemorrhage; UTI, urinary tract infection.