Trial Outcomes & Findings for Assess the Penumbra System in the Treatment of Acute Stroke (NCT NCT01429350)

NCT ID: NCT01429350

Last Updated: 2020-09-22

Results Overview

The assessor is blinded to patient treatment assignment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2020-09-22

Participant Flow

Participant milestones

Measure	IV rtPA IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	IV rtPA and IA Penumbra System Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device
Overall Study STARTED	53	55
Overall Study As-Treated	62	43
Overall Study Per Protocol	41	37
Overall Study 90 Day	46	50
Overall Study COMPLETED	46	50
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assess the Penumbra System in the Treatment of Acute Stroke

Baseline characteristics by cohort

Measure	IV rtPA n=53 Participants IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	IV rtPA and IA Penumbra System n=55 Participants Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device	Total n=108 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 10 • n=5 Participants	67 years STANDARD_DEVIATION 11 • n=7 Participants	68.7 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	21 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	34 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

The assessor is blinded to patient treatment assignment.

Outcome measures

Measure	IV rtPA n=46 Participants IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	IV rtPA and IA Penumbra System n=50 Participants Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device
Good Functional Outcome as Defined by a Modified Rankin Score of 0-2	14 Participants	19 Participants

PRIMARY outcome

Timeframe: 90 days

Population: The number of participants here are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants started based on participant flow. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.

A Serious Adverse Event is defined as an event that:

1. Led to death

2. Led to a serious deterioration in the health of the patient that:

• Resulted in life-threatening illness or injury
• Resulted in permanent impairment of a body structure or a body function
• Required in-patient hospitalization or prolongation of existing hospitalization
• Resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function
• Led to fetal distress, fetal death or a congenital abnormality or birth defect

Outcome measures

Measure	IV rtPA n=62 Participants IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	IV rtPA and IA Penumbra System n=43 Participants Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device
Incidence of All Serious Adverse Events	30 Participants	18 Participants

SECONDARY outcome

Timeframe: 30 days

Population: 30 day good clinical outcome based on ITT (intent-to-treat) population.

Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIH stroke scale score at Discharge, a NIH stroke scale score of 0-1 at Discharge; or a 30-day modified Rankin scale score of 0-2

Outcome measures

Measure	IV rtPA n=53 Participants IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	IV rtPA and IA Penumbra System n=53 Participants Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device
Good Clinical Outcome	17 Participants	24 Participants

SECONDARY outcome

Timeframe: 90 days

Population: The number of participants here are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants started based on participant flow. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.

A symptomatic intracranial hemorrhage is defined as 24 hour CT evidence of an ECASS defined ICH and a 4-point or more worsening of the NIH Stroke Scale score

Outcome measures

Measure	IV rtPA n=62 Participants IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	IV rtPA and IA Penumbra System n=43 Participants Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device
Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage	6 Participants	4 Participants

Adverse Events

IV rtPA

Serious events: 32 serious events

Other events: 58 other events

Deaths: 0 deaths

IV rtPA and IA Penumbra System

Serious events: 20 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	IV rtPA n=62 participants at risk IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	IV rtPA and IA Penumbra System n=43 participants at risk Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device
Cardiac disorders Acute myocardial infarction	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Arrhythmia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Atrial fibrillation	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Cardiac arrest	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Cardiac failure congestive	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Cardiogenic shock	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Ventricular fibrillation	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Dysphagia	11.3% 7/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Gastrointestinal haemorrhage	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Haematochezia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Hematemesis	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Chest pain	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Thrombosis in device	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Vessel puncture site haematoma	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Enterocolitis infectious	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Pneumonia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Sepsis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Urinary tract infection	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Gun shot wound	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Malnutrition	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Aphasia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Brain oedema	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Carotid artery occlusion	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebral haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebrovascular accident	9.7% 6/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Haemorrhage intracranial	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Haemorrhagic transformation stroke	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Intraventricular haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Ischaemic stroke	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Partial seizures	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Mental status changes	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Haematuria	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Renal failure	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Renal failure acute	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Deep vein thrombosis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.

Other adverse events

Measure	IV rtPA n=62 participants at risk IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg intravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg	IV rtPA and IA Penumbra System n=43 participants at risk Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System Penumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Blood and lymphatic system disorders Anaemia	6.5% 4/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	18.6% 8/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Blood and lymphatic system disorders Leukocytosis	8.1% 5/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	9.3% 4/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Blood and lymphatic system disorders Leukopenia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Blood and lymphatic system disorders Thrombocytopenia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Blood and lymphatic system disorders Thrombocytosis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Acute Myocardial Infarction	6.5% 4/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Aortic valve sclerosis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Arrhythmia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Atrial Fibrillation	17.7% 11/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	23.3% 10/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Atrial flutter	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Atrial thrombosis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Atrioventricular block first degree	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Bradycardia	6.5% 4/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Cardiac arrest	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Cardiac failure congestive	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	9.3% 4/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Cardiogenic shock	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Cardiomegaly	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Diastolic dysfunction	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Extrasystoles	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Heart valve incompetence	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Left valve incomptence	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Left atrial dilatation	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Mitral valve calcification	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Palpitations	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Sinus tachycardia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Supraventricular tachycardia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Tachycardia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Ventricular extrasystoles	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Ventricular fibrillation	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Ventricular hypokinesia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Cardiac disorders Ventricular tachycardia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Congenital, familial and genetic disorders Atrial septal defect	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Ear and labyrinth disorders Ear pain	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Eye disorders Conjunctivitis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Eye disorders Dry Eye	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Eye disorders Eye pain	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Abdominal distension	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Abdominal pain	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Constipation	14.5% 9/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	14.0% 6/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Diarrhoea	6.5% 4/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Dysphagia	14.5% 9/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	11.6% 5/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Gastritis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Gastrointestinal haemorrhage	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Gingival bleeding	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Haematochezia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Hematesis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Mouth haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Gastrointestinal disorders Nausea	11.3% 7/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Peptic ulcer	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Vomiting	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Asthenia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Chest pain	6.5% 4/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Facial pain	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Fatigue	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Impaired healing	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Oedema	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Oedema peripheral	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Pain	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Pyrexia	11.3% 7/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	11.6% 5/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Thrombosis in device	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Unevaluable event	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Vessel puncture site haematoma	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Vessel puncture site haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Immune system disorders Hypersensitivity	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Bronchitis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Bronchopneumonia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Candidiasis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Cellulitis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Clostridal infection	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Clostridium difficile colitis	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Enterocolitis infectious	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Eosophageal candiasis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Oral candiasis	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Oral infection	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Parotitis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Pneumonia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Sepsis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Sinusitis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Upper respiratory tract infection	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Infections and infestations Urinary tract infection	25.8% 16/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	27.9% 12/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Contusion	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Fall	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Gun shot wound	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Haematuria traumatic	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Incision site complication	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Incision site haemorrhage	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Incision site hypoaesthesia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Laceration	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Procedural nausea	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Scrotal haematoma	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Subdural haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Injury, poisoning and procedural complications Wound	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Antithrombin III decreased	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Blood calcium decreased	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Blood magnesium decreased	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Body temperature increased	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Electrocardiogram QT prolonged	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Haemoglobin decreased	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Hepatic enzyme increased	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations Troponin increased	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Investigations White blood cell count increased	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Dehydration	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Electrolyte imbalance	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Gout	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hyperchloraemia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypercholesterolaemia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hyperglycaemia	6.5% 4/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	9.3% 4/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hyperkalaemia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hyperlipidaemia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	9.3% 4/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypernatraemia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypervolaemia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypocalcaemia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypoglycaemia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypokalaemia	19.4% 12/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	25.6% 11/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypomagnesaemia	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	11.6% 5/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hyponatraemia	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Hypophosphataemia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
General disorders Hypovolaemia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Malnutrition	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	11.6% 5/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Metabolic acidosis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Metabolism and nutrition disorders Vitamin D deficiency	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Musculoskeletal and connective tissue disorders Muscle spasms	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Musculoskeletal and connective tissue disorders Myalgia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Musculoskeletal and connective tissue disorders Neck pain	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Musculoskeletal and connective tissue disorders Pain in extremity	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Aphasia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Basal ganglia haemorrhage	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Brain oedema	14.5% 9/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	11.6% 5/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Carotid artery dissection	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Carotid artery occlusion	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebellar infarction	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebral artery embolism	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebral artery occlusion	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebral artery stenosis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebral haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebral infarction	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebral thrombosis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebrovascular accident	11.3% 7/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Cerebrovascular spasm	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	9.3% 4/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Complex regional pain syndrome	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Convulsion	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Dementia Alzheimer's type	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Dizziness	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Haemorrhage intracranial	30.6% 19/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	32.6% 14/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Haemorrhagic cerebral infarction	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Haemorrhagic transformation stroke	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Headache	12.9% 8/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	14.0% 6/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Hydrocephalus	12.9% 8/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	14.0% 6/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Hypertonia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Hypoaesthesia	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Intracranial pressure increased	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Intraventricular haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Ischaemic stroke	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Lethargy	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Loss of consciousness	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Memory impairment	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Neurological decompensation	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Neuropathy peripheral	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Partial seizures	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Somnolence	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Stroke in evolution	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Nervous system disorders Syncope	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Agitation	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Anxiety	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Anxiety disorder	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Confusional state	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Delirium	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Depression	11.3% 7/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	11.6% 5/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Hallucination	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Insomnia	8.1% 5/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Mental status changes	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Restlessness	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Sleep disorder	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Psychiatric disorders Calculus urinary	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Cystitis noninfective	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Haematuria	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Incontinence	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Renal failure	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Renal failure acute	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Renal and urinary disorders Renal impairment	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Reproductive system and breast disorders Urinary retention	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Diaphragmatic hernia	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Hyperventilation	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	6.5% 4/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	11.6% 5/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	4.7% 2/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	7.0% 3/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Respiratory, thoracic and mediastinal disorders Wheezing	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Skin and subcutaneous tissue disorders Blister	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Skin and subcutaneous tissue disorders Ecchymosis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Skin and subcutaneous tissue disorders Rash	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Skin and subcutaneous tissue disorders Skin lesion	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Accelerated hypertension	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Deep vein thrombosis	4.8% 3/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Haematoma	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Haemorrhage	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Hypertension	6.5% 4/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	14.0% 6/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Hypotension	8.1% 5/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	20.9% 9/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Orthostatic hypotension	3.2% 2/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Thrombophlebitis	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Thrombophlebitis superficial	1.6% 1/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	0.00% 0/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Thrombosis	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Vascular calcification	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	2.3% 1/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.
Vascular disorders Vasospasm	0.00% 0/62 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.	16.3% 7/43 The number of participants are taken from the as-treated population. Serious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.

Additional Information

Michaella Corso

Penumbra, Inc.

Phone: 510-995-2079

Email: mcorso@penumbrainc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60