Trial Outcomes & Findings for Tenecteplase in Stroke Patients Between 4.5 and 24 Hours (NCT NCT03785678)

NCT ID: NCT03785678

Last Updated: 2024-05-22

Results Overview

The the modified Rankin score (mRS) is a 6-point scale commonly used to assess disability due to stroke, with higher values indicating worse outcomes. 0 = No symptoms 1. = No significant disability 2. = Slight disability 3. = Moderate disability 4. = Moderately severe disability 5. = Severe disability 6. = Death

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 458 participants
• Primary outcome timeframe: Day 90
• Results posted on: 2024-05-22

Participant Flow

Participant milestones

Measure	Tenecteplase Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Overall Study STARTED	228	230
Overall Study COMPLETED	175	181
Overall Study NOT COMPLETED	53	49

Reasons for withdrawal

Measure	Tenecteplase Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Overall Study Death	44	42
Overall Study Lost to Follow-up	4	2
Overall Study Physician Decision	0	2
Overall Study Withdrawal by Subject	5	3

Baseline Characteristics

Tenecteplase in Stroke Patients Between 4.5 and 24 Hours

Baseline characteristics by cohort

Measure	Tenecteplase n=228 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=230 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Total n=458 Participants Total of all reporting groups
Age, Continuous	70.2 Years STANDARD_DEVIATION 13.5 • n=93 Participants	71.3 Years STANDARD_DEVIATION 13.6 • n=4 Participants	70.8 Years STANDARD_DEVIATION 13.5 • n=27 Participants
Sex: Female, Male Female	122 Participants n=93 Participants	123 Participants n=4 Participants	245 Participants n=27 Participants
Sex: Female, Male Male	106 Participants n=93 Participants	107 Participants n=4 Participants	213 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=93 Participants	22 Participants n=4 Participants	39 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	201 Participants n=93 Participants	197 Participants n=4 Participants	398 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=93 Participants	11 Participants n=4 Participants	21 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Asian	11 Participants n=93 Participants	9 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Black or African American	31 Participants n=93 Participants	32 Participants n=4 Participants	63 Participants n=27 Participants
Race (NIH/OMB) White	169 Participants n=93 Participants	170 Participants n=4 Participants	339 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 90

Population: The ITT population consisted of all randomized participants who provided informed consent, with participants grouped according to their assigned treatment.

The the modified Rankin score (mRS) is a 6-point scale commonly used to assess disability due to stroke, with higher values indicating worse outcomes.

0 = No symptoms

1. = No significant disability

2. = Slight disability

3. = Moderate disability

4. = Moderately severe disability

5. = Severe disability

6. = Death

Outcome measures

Measure	Tenecteplase n=226 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=229 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Ordinal Modified Rankin Scale (mRS) Score at Day 90 0	35 Count of participants	31 Count of participants
Ordinal Modified Rankin Scale (mRS) Score at Day 90 1	38 Count of participants	30 Count of participants
Ordinal Modified Rankin Scale (mRS) Score at Day 90 2	31 Count of participants	36 Count of participants
Ordinal Modified Rankin Scale (mRS) Score at Day 90 3	34 Count of participants	41 Count of participants
Ordinal Modified Rankin Scale (mRS) Score at Day 90 4	29 Count of participants	34 Count of participants
Ordinal Modified Rankin Scale (mRS) Score at Day 90 5	15 Count of participants	13 Count of participants
Ordinal Modified Rankin Scale (mRS) Score at Day 90 6	44 Count of participants	44 Count of participants

SECONDARY outcome

Timeframe: Day 90

Population: The ITT population consisted of all randomized participants who provided informed consent, with participants grouped according to their assigned treatment.

Functional independence, was defined as an mRS of 0-2 (no symptoms to mild symptoms), at Day 90.

Outcome measures

Measure	Tenecteplase n=226 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=229 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Proportion of Patients With Functional Independence at Day 90 mRS ≤ 2 at Day 90	46.0 Percentage of participants	42.4 Percentage of participants
Proportion of Patients With Functional Independence at Day 90 mRS > 2 at Day 90	54.0 Percentage of participants	57.6 Percentage of participants

SECONDARY outcome

Timeframe: Day 2

Population: The ITT population consisted of all randomized participants who provided informed consent, with participants grouped according to their assigned treatment.

This endpoint measured complete or partial recanalization (restored blood flow) on CT angiography (CTA)/magnetic resonance angiography (MRA) post-randomization, defined as complete or partial recanalization on CT angiography (CTA)/magnetic resonance angiography (MRA).

Outcome measures

Measure	Tenecteplase n=193 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=194 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Proportion of Patients With Recanalization at 24 Hours Post-randomization Complete recanalization	76.7 Percentage of participants	63.9 Percentage of participants
Proportion of Patients With Recanalization at 24 Hours Post-randomization None or partial recanalization	23.3 Percentage of participants	36.1 Percentage of participants

SECONDARY outcome

Timeframe: Day 2

Population: The ITT population consisted of all randomized participants who provided informed consent, with participants grouped according to their assigned treatment.

This endpoint was defined by the proportion of participants with reperfusion (the restoration of blood flow to an organ or tissue after having been blocked) at 24 hours post-randomization, defined as > 90% reduction in Tmax > 6s lesion volume.

Outcome measures

Measure	Tenecteplase n=174 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=182 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Proportion of Patients With Reperfusion at 24 Hours Post-randomization > 90% reduction in Tmax > 6s lesion volume	56.9 Percentage of participants	57.7 Percentage of participants
Proportion of Patients With Reperfusion at 24 Hours Post-randomization ≤ 90% reduction	43.1 Percentage of participants	42.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: The ITT population consisted of all randomized participants who provided informed consent, with participants grouped according to their assigned treatment.

Angiographic reperfusion was evaluated using the modified Thrombolysis in Cerebral Infarction (TICI) Scale:

0: No perfusion or anterograde flow beyond site of occlusion.

1. Contrast passes the area of occlusion but fails to opacify the entire cerebral bed distal to the obstruction during angiographic run.

2. Partial perfusion wherein the contrast passes the occlusion and opacifies the distal arterial bed but rate of entry or clearance from the bed is slower than non-involved territories 2A: < 50% of territory visualized 2B: ≥ 50% of territory is visualized 2C: Near complete perfusion except for slow flow in a few distal cortical vessels or presence of small distal cortical emboli

3. Complete reperfusion with normal filling.

Outcome measures

Measure	Tenecteplase n=175 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=178 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Proportion of Patients With Angiographic Reperfusion at Completion of Angiographic Procedure Achieving TICI 2b or TICI 3	89.1 Percentage of participants	85.4 Percentage of participants
Proportion of Patients With Angiographic Reperfusion at Completion of Angiographic Procedure Achieving TICI < 2b	10.9 Percentage of participants	14.6 Percentage of participants

SECONDARY outcome

Timeframe: Day 90

Population: The ITT population consisted of all randomized participants who provided informed consent, with participants grouped according to their assigned treatment.

The National Institutes of Health Stroke Score (NIHSS) is a 15-item scale that measures neurological deficit in acute stroke patients. Each item is ranked using a 3-, 4-, or 5-point scale, including allowances for items that cannot be scored due to the patient's condition, with higher scores indicating more severe deficit. Total scores range from 0-42, with higher scores indicating more severe deficits.

Outcome measures

Measure	Tenecteplase n=79 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=89 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Median NIHSS Score at Day 90	1.0 Scores on a scale Interval 0.0 to 31.0	1.0 Scores on a scale Interval 0.0 to 26.0

SECONDARY outcome

Timeframe: Day 90

Population: The ITT population consisted of all randomized participants who provided informed consent, with participants grouped according to their assigned treatment.

The Barthel Index (BI) is a 10-item ordinal scale used to measure performance in activities of daily living (ADL) and mobility. The BI scoring range is from 0-100, with lower scores representing greater dependency.

Outcome measures

Measure	Tenecteplase n=81 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=89 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Proportion of Patients With a Barthel Index (BI) Score ≥ 95 at Day 90 BI score ≥ 95 at Day 90	60.5 Percentage of participants	58.4 Percentage of participants
Proportion of Patients With a Barthel Index (BI) Score ≥ 95 at Day 90 BI score < 95 at Day 90	39.5 Percentage of participants	41.6 Percentage of participants

SECONDARY outcome

Timeframe: Day 90

Population: The ITT population consisted of all randomized participants who provided informed consent, with participants grouped according to their assigned treatment.

The Glasgow Outcome Scale (GOS) is a scale used to assess recovery of participants with brain damage. The scale has 5 categories:

1. = Death

2. = Persistent vegetative state

3. = Severe disability

4. = Moderate disability

5. = Good recovery

The GOS was re-scaled from observed data. For this measure, 1 = good recovery and 5 = death.

Outcome measures

Measure	Tenecteplase n=126 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=133 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Proportion of Patients With Good Recovery Based on the Glasgow Outcome Scale (GOS) at Day 90 Good recovery GOS score (=1)	36.5 Percentage of participants	30.8 Percentage of participants
Proportion of Patients With Good Recovery Based on the Glasgow Outcome Scale (GOS) at Day 90 GOS score > 1	63.5 Percentage of participants	69.2 Percentage of participants

SECONDARY outcome

Timeframe: Within 36 hours (Day 2) of treatment

Population: The safety population consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.

Outcome measures

Measure	Tenecteplase n=218 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=214 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Incidence of Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours	3.2 Percentage of participants	2.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 30 and Day 90

Population: The safety population consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.

Outcome measures

Measure	Tenecteplase n=218 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=214 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Mortality Rate up to Day 30 and Day 90 Death within 30 days	14.7 Percentage of participants	15.0 Percentage of participants
Mortality Rate up to Day 30 and Day 90 Death within 90 days	19.7 Percentage of participants	18.2 Percentage of participants

SECONDARY outcome

Timeframe: Day 3

Population: The safety population consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.

Outcome measures

Measure	Tenecteplase n=218 Participants Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=214 Participants Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Proportion of Patients With Parenchymal Hematoma Type 2 (PH2) at the 72-96 Hour Visit	3.7 Percentage of participants	2.8 Percentage of participants

Adverse Events

Tenecteplase

Serious events: 91 serious events

Other events: 145 other events

Deaths: 44 deaths

Placebo

Serious events: 102 serious events

Other events: 136 other events

Deaths: 44 deaths

Serious adverse events

Measure	Tenecteplase n=218 participants at risk Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=214 participants at risk Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Nervous system disorders Presyncope	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Blood and lymphatic system disorders Anaemia	3.2% 7/218 • Number of events 7 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Blood and lymphatic system disorders Blood loss anaemia	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Blood and lymphatic system disorders Coagulopathy	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Acute myocardial infarction	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Arrhythmia	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Atrial fibrillation	1.4% 3/218 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.9% 4/214 • Number of events 4 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Atrial flutter	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Atrioventricular block	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Bradycardia	1.4% 3/218 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Cardiac arrest	1.4% 3/218 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Cardiac failure	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Cardiac failure congestive	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Cardiac tamponade	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Cardio-respiratory arrest	1.4% 3/218 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Myocardial infarction	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Pericardial effusion	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Pulseless electrical activity	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Sinus node dysfunction	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Tachycardia	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Ventricular tachycardia	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Colitis	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Dysphagia	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.4% 3/218 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Intestinal perforation	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Intra-abdominal haematoma	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Melaena	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
General disorders Chest pain	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
General disorders Death	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
General disorders Localised oedema	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
General disorders Multiple organ dysfunction syndrome	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
General disorders Pyrexia	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
General disorders Vascular stent thrombosis	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Hepatobiliary disorders Cholecystitis	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Hepatobiliary disorders Cholelithiasis	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Immune system disorders Hypersensitivity	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Bacteraemia	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Clostridium difficile infection	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Empyema	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Gastritis viral	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Infection	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Osteomyelitis	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Pneumonia	2.3% 5/218 • Number of events 5 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Pneumonia aspiration	1.8% 4/218 • Number of events 4 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Pneumonia bacterial	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Pneumonia klebsiella	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Pneumonia viral	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Sepsis	2.3% 5/218 • Number of events 5 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	2.8% 6/214 • Number of events 6 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Septic shock	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Staphylococcal infection	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Urinary tract infection	2.3% 5/218 • Number of events 5 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Urosepsis	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Wound infection	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Injury, poisoning and procedural complications Brain herniation	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Injury, poisoning and procedural complications Fall	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Injury, poisoning and procedural complications Fracture	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Injury, poisoning and procedural complications Limb injury	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Injury, poisoning and procedural complications Rib fracture	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Injury, poisoning and procedural complications Sternal fracture	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Investigations NIH stroke scale abnormal	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Investigations Neurological examination abnormal	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Investigations Troponin I increased	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Metabolism and nutrition disorders Decreased appetite	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Metabolism and nutrition disorders Fluid retention	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Metabolism and nutrition disorders Malnutrition	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Musculoskeletal and connective tissue disorders Sacral pain	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma metastatic	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Basal ganglia haemorrhage	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Brain oedema	3.2% 7/218 • Number of events 7 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Carotid artery occlusion	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Carotid artery perforation	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Carotid artery thrombosis	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebellar infarction	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebral artery occlusion	2.3% 5/218 • Number of events 5 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	3.3% 7/214 • Number of events 7 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebral artery perforation	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebral disorder	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebral haematoma	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebral haemorrhage	1.8% 4/218 • Number of events 4 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 4 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebral infarction	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 4 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebrovascular accident	2.8% 6/218 • Number of events 7 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	3.3% 7/214 • Number of events 7 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebrovascular disorder	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Depressed level of consciousness	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Dysarthria	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Embolic stroke	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Encephalopathy	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Haemorrhage intracranial	1.8% 4/218 • Number of events 4 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	2.3% 5/214 • Number of events 5 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Haemorrhagic transformation stroke	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Hypoaesthesia	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Intraventricular haemorrhage	2.3% 5/218 • Number of events 5 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Ischaemic stroke	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Metabolic encephalopathy	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Nervous system disorder	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Neurological decompensation	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Peroneal nerve palsy	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Seizure	1.4% 3/218 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Serotonin syndrome	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Stroke in evolution	3.2% 7/218 • Number of events 7 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	6.1% 13/214 • Number of events 13 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Subarachnoid haemorrhage	2.8% 6/218 • Number of events 6 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.9% 4/214 • Number of events 4 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Syncope	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Toxic encephalopathy	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Psychiatric disorders Agitation	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Psychiatric disorders Delirium	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Psychiatric disorders Mental status changes	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Renal and urinary disorders Acute kidney injury	2.3% 5/218 • Number of events 5 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Renal and urinary disorders Renal failure	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Renal and urinary disorders Renal impairment	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.2% 7/218 • Number of events 7 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Aspiration	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Pneumonitis aspiration	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	2.8% 6/214 • Number of events 6 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.93% 2/214 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 8/218 • Number of events 9 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	3.7% 8/214 • Number of events 8 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Stridor	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Skin and subcutaneous tissue disorders Skin necrosis	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Surgical and medical procedures Aortic valve replacement	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Surgical and medical procedures Arterial aneurysm repair	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Surgical and medical procedures Therapy cessation	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Air embolism	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Aortic stenosis	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Arterial occlusive disease	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Deep vein thrombosis	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.4% 3/214 • Number of events 3 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Distributive shock	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Haematoma	0.46% 1/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Hypertension	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Hypotension	3.7% 8/218 • Number of events 8 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Labile blood pressure	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Peripheral artery haematoma	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Peripheral artery thrombosis	0.92% 2/218 • Number of events 2 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Shock haemorrhagic	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Thrombosis	0.46% 1/218 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.00% 0/214 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Vasospasm	0.00% 0/218 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.

Other adverse events

Measure	Tenecteplase n=218 participants at risk Participants received Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.	Placebo n=214 participants at risk Participants received placebo administered as a single bolus injection over 5 seconds, administered within 4.5 - 24 hours of the onset of internal carotid artery (ICA) or middle cerebral artery (MCA) stroke.
Blood and lymphatic system disorders Anaemia	6.0% 13/218 • Number of events 13 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	1.9% 4/214 • Number of events 4 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Cardiac disorders Atrial fibrillation	5.5% 12/218 • Number of events 12 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	8.4% 18/214 • Number of events 19 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Constipation	6.0% 13/218 • Number of events 13 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	6.1% 13/214 • Number of events 13 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Gastrointestinal disorders Dysphagia	6.0% 13/218 • Number of events 13 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	2.3% 5/214 • Number of events 5 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
General disorders Pyrexia	5.5% 12/218 • Number of events 12 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	7.0% 15/214 • Number of events 16 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Pneumonia	5.5% 12/218 • Number of events 12 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	2.8% 6/214 • Number of events 6 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Infections and infestations Urinary tract infection	13.3% 29/218 • Number of events 31 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	9.3% 20/214 • Number of events 21 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Metabolism and nutrition disorders Hypokalaemia	8.3% 18/218 • Number of events 19 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	12.6% 27/214 • Number of events 27 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Cerebral haemorrhage	10.1% 22/218 • Number of events 22 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	6.1% 13/214 • Number of events 13 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Haemorrhage intracranial	6.4% 14/218 • Number of events 14 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	4.7% 10/214 • Number of events 11 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Haemorrhagic transformation stroke	12.8% 28/218 • Number of events 29 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	11.7% 25/214 • Number of events 26 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Headache	8.3% 18/218 • Number of events 19 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	9.8% 21/214 • Number of events 24 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Nervous system disorders Subarachnoid haemorrhage	7.3% 16/218 • Number of events 16 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	7.9% 17/214 • Number of events 17 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Haematoma	6.0% 13/218 • Number of events 13 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	0.47% 1/214 • Number of events 1 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Haemorrhagic infarction	9.2% 20/218 • Number of events 20 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	9.8% 21/214 • Number of events 21 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.
Vascular disorders Hypotension	5.5% 12/218 • Number of events 12 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.	7.9% 17/214 • Number of events 18 • From treatment visit to Day 90 follow-up All-cause mortality was assessed for all participants. Serious Adverse Events and Other Adverse Events were assessed for the safety population, which consisted of all randomized participants who received tenecteplase or placebo, with participants grouped according to the treatment actually received.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER