Table 3

Serious adverse events

Intravenous rtPA (IVT)IVT+MT
No. with any SAE11 (34%)15 (45%)
No. of SAEs reported1521
Probably or definitely related to study procedures32
Fatal SAEs47
 No. fatal SAEs <7 days after onset16
 Fatal neurological events <7 days after onset14
Intracerebral haemorrhage events
 Any ICH33
ICH events on CT
 HI1 or HI21213
Non-ICH SAEs1218
 MI/acute coronary syndrome21
 Gingival bleeding10
 Brain swelling24
 Recurrent ischaemic stroke03
 Neurological deterioration, not definitely ICH or swelling01
 Other3 (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.