Trial Outcomes & Findings for A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19 (NCT NCT04640194)

Last Updated: 2024-03-20

Results Overview

From randomisation to either an improvement of 2 points on the 11-point World Health Organization (WHO) Clinical Progression Scale (from 0 to 10, a low score indicates a better outcome) or discharge from the hospital, whichever comes first. Full scale: 0=Uninfected; no viral RNA detected 1. Asymptomatic; viral RNA detected 2. Symptomatic; independent 3. Symptomatic; assistance needed 4. Hospitalised; no oxygen therapy 5. Hospitalised; oxygen by mask or nasal prongs 6. Hospitalised; oxygen by NIV or high flow 7. Intubation and mechanical ventilation, PaO2/FiO2=150 or SpO2/FiO2=200 8. Mechanical ventilation PaO2/FiO2\<150 (SpO2/FiO2\<200) or vasopressors 9. Mechanical ventilation PaO2/FiO2\<150 and vasopressors, dialysis, or ECMO 10. Dead Patients that have not met the endpoint were censored at Day 28 if they died prior to Day 28. Patients receiving bail out therapy without having first met the endpoint, were censored on the day of bail-out (hypothetical estimand).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

104 participants

Primary outcome timeframe

Up to 28 days.

Results posted on

2024-03-20

Participant Flow

A Phase IIb/III randomised, controlled, open-label, sequential, parallel-group, operationally seamless adaptive study with two parts. Part 1 was a Phase IIb proof-of-concept exploratory comparison of two groups each receiving a different dose of alteplase plus Standard of Care (SOC) versus a group receiving SOC alone. Part 2 was a confirmatory Phase III study; Part 2 will include one group receiving the selected dose of alteplase plus SOC vs. one group receiving SOC alone.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Part 1: Alteplase Low Dose 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Overall Study STARTED	20	20	22	17	8	12	5
Overall Study COMPLETED	17	12	22	9	8	8	5
Overall Study NOT COMPLETED	3	8	0	8	0	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Alteplase Low Dose 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Overall Study Adverse Event	3	7	5	4
Overall Study pO2/FIO2 ratio too high	0	0	1	0
Overall Study fibrinogen level too low	0	0	1	0
Overall Study mild bleeding	0	0	1	0
Overall Study Transferred from Intensive Care Unit to Hospital Ward	0	1	0	0

Baseline Characteristics

A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Alteplase Low Dose n=20 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=17 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients n=8 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients n=12 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients n=5 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Total n=104 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 12.0 • n=5 Participants	61.6 years STANDARD_DEVIATION 9.8 • n=7 Participants	60.3 years STANDARD_DEVIATION 13.0 • n=5 Participants	63.4 years STANDARD_DEVIATION 11.5 • n=4 Participants	60.5 years STANDARD_DEVIATION 10.9 • n=21 Participants	59.7 years STANDARD_DEVIATION 11.1 • n=10 Participants	67.6 years STANDARD_DEVIATION 10.5 • n=115 Participants	61.5 years STANDARD_DEVIATION 11.3 • n=6 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	32 Participants n=6 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=10 Participants	4 Participants n=115 Participants	72 Participants n=6 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=6 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race/Ethnicity, Customized White	13 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	10 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=10 Participants	1 Participants n=115 Participants	61 Participants n=6 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander & White	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized American Indian or Alaska Native & White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Missing	7 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	38 Participants n=6 Participants
WHO Clinical Progression Scale 0	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
WHO Clinical Progression Scale 1	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
WHO Clinical Progression Scale 2	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
WHO Clinical Progression Scale 3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
WHO Clinical Progression Scale 4	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
WHO Clinical Progression Scale 5	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
WHO Clinical Progression Scale 6	16 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants	8 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	73 Participants n=6 Participants
WHO Clinical Progression Scale 7	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	9 Participants n=6 Participants
WHO Clinical Progression Scale 8	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	8 Participants n=10 Participants	0 Participants n=115 Participants	11 Participants n=6 Participants
WHO Clinical Progression Scale 9	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	11 Participants n=6 Participants
WHO Clinical Progression Scale 10	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: Up to 28 days.

Population: Full Analysis Set (FAS) consisted of all randomised patients with at least one baseline and one post baseline assessment relating to the primary endpoint.

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=20 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=17 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients n=8 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients n=12 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients n=5 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Time to Clinical Improvement or Hospital Discharge up to Day 28	NA days Interval 14.0 to Median and Upper limit was not achieved, due to insufficient numbers of participants with events.	19.0 days Interval 9.0 to Upper limit was not achieved, due to insufficient numbers of participants with events.	NA days Interval 17.0 to Median and Upper limit was not achieved, due to insufficient numbers of participants with events.	22.0 days Interval 7.0 to Upper limit was not achieved, due to insufficient numbers of participants with events.	NA days Interval 8.0 to Median and Upper limit was not achieved, due to insufficient numbers of participants with events.	25.5 days Interval 13.0 to Upper limit was not achieved, due to insufficient numbers of participants with events.	NA days Interval 4.0 to Median and Upper limit was not achieved, due to insufficient numbers of participants with events.

SECONDARY outcome

Timeframe: From start of treatment (Alteplase) or randomisation (SOC) (day 1) till Day 6, up to 6 days.

Population: The Treated Set (TS) consisted of all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.

Number of subjects with major bleeding events (MBE). Major bleeding events (MBE) according to International Society on Thrombosis and Haemostasis \[ISTH\] definition until Day 6. Definition of a major bleed: •Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or •Bleeding associated with a reduction in hemoglobin of at least 2 gram/deciliter (1.24 millimole/Liter), or leading to transfusion of two or more units of blood or packed cells and/or •Fatal bleed

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=20 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=17 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients n=8 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients n=12 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients n=5 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Number of Subjects With Major Bleeding Events (MBE) at Day 6	1 Participants	4 Participants	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 28 days.

Population: Full Analysis Set (FAS) consisted of all randomised patients with at least one baseline and one post baseline assessment relating to the primary endpoint.

All cause mortality at Day 28. If it is unknown whether the patient was dead at end of Day 28, then it will be assumed that the patient did not die up to Day 28, regardless of the reason. This unfavorable endpoint is met if: * the last known status of the patient is 10 on the WHO clinical progression scale by the end of Day 28, or * vital status is dead within 28 days

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=20 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=17 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients n=8 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients n=12 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients n=5 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
All Cause Mortality at Day 28	2 Participants	3 Participants	6 Participants	1 Participants	2 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 28 days.

Population: Full Analysis Set (FAS) consisted of all randomised patients with at least one baseline and one post baseline assessment relating to the primary endpoint.

Treatment failure defined as all cause mortality or mechanical ventilation at Day 28.

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=20 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=17 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients n=8 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients n=12 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients n=5 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Number of Subjects With Treatment Failure at Day 28	8 Participants	8 Participants	11 Participants	6 Participants	3 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 28 days.

Population: Full Analysis Set (FAS) consisted of all randomised patients with at least one baseline and one post baseline assessment relating to the primary endpoint. The endpoint was only planned for subjects in Part 1.

Number of ventilator-free days (VFDs) from start of treatment to Day 28. 'Ventilator' is defined as 'assisted breathing' but it refers to mechanical invasive ventilation. The number of VFDs starts from when the patient has a 'lasting' value on the WHO clinical progression scale of ≤ 6, and ends on Day 28. A lasting value of ≤ 6 means that the value cannot exceed 6 at a later timepoint. If the patient is liberated from the ventilator on Day x, then the number of VFDs is 28-x. If a patient has withdrawn consent prior to day 28 then he will have a missing value for VFD. In any case, if the status of the patient at Day 28 is death, as determined from the vital status page then the VFD=0.

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=20 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Number of Ventilator-free Days at Day 28	10.6 Days Standard Error 2.9	11.8 Days Standard Error 2.9	7.5 Days Standard Error 2.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 0) and Day 6 of treatment

Number of subjects with improvement of Sequential (sepsis-related) Organ Failure Assessment (SOFA) score by ≥2 points from baseline to end of Day 6. The Sequential Organ Failure Assessment (SOFA) scores six variables: respiratory, coagulation, liver, Cardiovascular, central nervous system and renal. Each variable is score from 0 (best outcome) to 4 (worst outcome) with a total score calculated as the sum of all six variables ranging from 0 (best outcome) to 24 (worst outcome).

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=20 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Number of Subjects With Improvement of Sequential (Sepsis-related) Organ Failure Assessment (SOFA) Score by ≥2 Points at Day 6	4 Participants	2 Participants	6 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 6 days.

Population: Full Analysis Set (FAS) consisted of all randomised patients with at least one baseline and one post baseline assessment relating to the primary endpoint. Only subjects with non-missing endpoint data were included. The endpoint was only planned for subjects in Part 1.

Daily average PaO2/FiO2 ratio (or inferred PaO2/FiO2 ratio from SpO2) change from baseline to Day 6. This assessment was measured approximately 3-times daily. All available values on each of these days, regardless of the position of the patient when being measured, were averaged in order to determine the daily average PaO2/FiO2 ratio for that patient. The higher the value the better the health status of the patient. If the patient was still in hospital during day 6 then the day 6 daily average value was used, if available. If the patient was discharged from hospital prior to day 6 then the daily average at the time of hospital discharge was used as a surrogate for day 6, if available. If the patient died prior to day 6 then there was no imputation but the death handled as failure in the determination of the difference in medians and 95% CI. Based upon this, the change from baseline for each patient was calculated.

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=19 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=19 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Daily Average PaO2/FiO2 Ratio Change From Baseline to Day 6	32.2 PaO2/FiO2 ratio Interval -24.0 to 56.2	58.5 PaO2/FiO2 ratio Interval 10.1 to 150.4	7.5 PaO2/FiO2 ratio Interval -14.7 to 33.5	—	—	—	—

SECONDARY outcome

Timeframe: Up to 28 days.

Number of oxygen-free days (OFD) up to Day 28. Oxygen-free is defined as free from assistance from oxygen support. The number of oxygen-free days starts from when the patient has a 'lasting' value on the WHO clinical progression scale of ≤ 4 and ends on Day 28. A lasting value of ≤ 4 means that the value cannot exceed 4 at a later timepoint. If the patient is liberated from oxygen on Day x, then the number of OFDs is 28-x. If a patient has withdrawn consent prior to day 28 then he will have a missing value for OFD. In any case, if the status of the patient at Day 28 is death, as determined from the vital status page then the OFD=0.

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=17 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=8 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=12 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=5 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Number of Oxygen-free Days up to Day 28	7.0 Days Interval 0.0 to 20.0	4.5 Days Interval 0.0 to 12.5	0.0 Days Interval 0.0 to 5.5	0.0 Days Interval 0.0 to 13.0	—	—	—

SECONDARY outcome

Timeframe: Up to 28 days.

Length of hospital stay up to day 28 was determined based upon the first hospital discharge date, or discharge to another care facility. If the patient died within the first 28 day period, then length of hospital stay was 28.

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=17 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=8 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=12 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=5 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Length of Hospital Stay up to Day 28	28.0 Days Interval 16.0 to 28.0	24.0 Days Interval 17.0 to 28.0	28.0 Days Interval 26.0 to 28.0	28.0 Days Interval 16.0 to 28.0	—	—	—

SECONDARY outcome

Timeframe: Up to 7 days.

Worst PaO2/FiO2 ratio (or inferred PaO2/FiO2 ratio from SpO2) change from baseline to day 6. This assessment was planned to be measured on each of days 0 to 6. but only whilst the patients was still in hospital. The worst (lowest) daily measurement will be used and the higher the value the better the health status of the patient. * If the patient was still in hospital during day 6 then the day 6 value was used * If the patient was discharged from hospital prior to day 6 then the value at the time of hospital discharge was used * If the patient died prior to day 6 then the last value prior to death was used * If day 6 value was missing but Day 5 value available, the day 5 value was used * If day 6 value was missing, no Day 5 value available, but day 7 available, then day 7 value was used * Otherwise value was set to missing for that patient. Based upon this, the change from baseline for each patient was calculated and used for the analysis.

Outcome measures

Outcome measures
Measure	Part 1: Alteplase Low Dose n=17 Participants 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=8 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=12 Participants Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=5 Participants 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Worst PaO2/FiO2 Ratio Change From Baseline to Day 6	70.8 PaO2/FiO2 ratio Standard Error 20.7	0.0 PaO2/FiO2 ratio Standard Error 29.2	-10.9 PaO2/FiO2 ratio Standard Error 13.1	3.4 PaO2/FiO2 ratio Standard Error 20.2	—	—	—

Adverse Events

Part 1: Alteplase Low Dose

Serious events: 8 serious events

Other events: 11 other events

Deaths: 6 deaths

Part 1: Alteplase High Dose

Serious events: 10 serious events

Other events: 11 other events

Deaths: 6 deaths

Part 1: Standard of Care

Serious events: 12 serious events

Other events: 12 other events

Deaths: 9 deaths

Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients

Serious events: 7 serious events

Other events: 12 other events

Deaths: 2 deaths

Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients

Serious events: 4 serious events

Other events: 4 other events

Deaths: 3 deaths

Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients

Serious events: 9 serious events

Other events: 11 other events

Deaths: 3 deaths

Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Alteplase Low Dose n=20 participants at risk 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 participants at risk 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 participants at risk Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=17 participants at risk 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients n=8 participants at risk Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients n=12 participants at risk 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients n=5 participants at risk Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Blood and lymphatic system disorders Anaemia	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Acute right ventricular failure	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Cardiac arrest	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Cardiogenic shock	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Myocardial injury	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Gingival bleeding	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Mouth haemorrhage	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Catheter site haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Multiple organ dysfunction syndrome	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Puncture site haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Vessel puncture site haematoma	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Hepatobiliary disorders Hepatic infarction	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Bacteraemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations COVID-19	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Device related bacteraemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Escherichia bacteraemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	11.8% 2/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia aspiration	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia bacterial	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia pneumococcal	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia staphylococcal	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pulmonary sepsis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Septic shock	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	18.2% 4/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Injury, poisoning and procedural complications Subcutaneous haematoma	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Injury, poisoning and procedural complications Tracheal haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Injury, poisoning and procedural complications Traumatic lung injury	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Injury, poisoning and procedural complications Vasoplegia syndrome	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Nervous system disorders Haemorrhage intracranial	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Nervous system disorders Ischaemic stroke	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Acute kidney injury	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Haematuria	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Renal failure	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	15.0% 3/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	17.6% 3/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	15.0% 3/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	16.7% 2/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	27.3% 6/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Vascular disorders Deep vein thrombosis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Vascular disorders Haematoma	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Vascular disorders Haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Vascular disorders Hypotension	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.

Other adverse events

Other adverse events
Measure	Part 1: Alteplase Low Dose n=20 participants at risk 0.3 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.02 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.3 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Alteplase High Dose n=20 participants at risk 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 1: Standard of Care n=22 participants at risk Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Part 1 subjects were randomized equally (1:1:1) across the three Part 1 arms.	Part 2: Alteplase High Dose - Non-invasive Mechanical Ventilation (NIV) Patients n=17 participants at risk 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Non-invasive Mechanical Ventilation (NIV) Patients n=8 participants at risk Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Non-invasive mechanical ventilation (NIV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 6. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Alteplase High Dose - Invasive Mechanical Ventilation (IMV) Patients n=12 participants at risk 0.6 milligram/kilogram (mg/kg) over 2 hours (Day 1) immediately followed by daily infusion of 0.04 mg/kg/hour over 12 hours (starting on Day 1 and up to Day 5), plus Standard of Care (SOC). One optional additional infusion of 0.6 mg/kg over 2 hours could be given once on Days 2 to 5 in case of clinical worsening, per investigator judgement. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).	Part 2: Standard of Care - Invasive Mechanical Ventilation (IMV) Patients n=5 participants at risk Standard of Care included best possible treatment regimen established locally and was in line with current guidelines for Acute respiratory distress syndrome treatment. Invasive mechanical ventilation (IMV) patients are those with a baseline World Health Organization (WHO) Clinical Progression Scale value of 7, 8 or 9. Part 2 subjects were randomized 2 (Alteplase) to 1 (SOC).
Blood and lymphatic system disorders Anaemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	11.8% 2/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Arrhythmia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Atrial fibrillation	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Bradycardia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Right ventricular failure	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Cardiac disorders Tachycardia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Constipation	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	15.0% 3/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	17.6% 3/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	25.0% 3/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	40.0% 2/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Faecaloma	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Gingival bleeding	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	16.7% 2/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Gastrointestinal disorders Nausea	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Administration site haematoma	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Catheter site haemorrhage	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	16.7% 2/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Chest pain	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Disease progression	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Hyperthermia	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Mucosal haemorrhage	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Oedema	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Oedema peripheral	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
General disorders Pyrexia	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Hepatobiliary disorders Biliary dilatation	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Hepatobiliary disorders Cholestasis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Aspergillus infection	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Bronchitis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Candida infection	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Enterobacter infection	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Enterococcal bacteraemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Klebsiella bacteraemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Neisseria infection	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Oral herpes	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	18.2% 4/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	17.6% 3/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	16.7% 2/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia bacterial	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia serratia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia staphylococcal	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Pneumonia streptococcal	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Staphylococcal infection	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Stenotrophomonas infection	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Tracheobronchitis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Urinary tract infection	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	25.0% 2/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Infections and infestations Vulvitis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Injury, poisoning and procedural complications Overdose	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Investigations Alanine aminotransferase increased	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Investigations Aspartate aminotransferase increased	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Investigations Fibrin D dimer increased	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Investigations Glomerular filtration rate increased	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Investigations Haemoglobin decreased	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Investigations Hepatic enzyme increased	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Cell death	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Hyperglycaemia	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	13.6% 3/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Hyperkalaemia	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	16.7% 2/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Hyperlactacidaemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Hypokalaemia	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	13.6% 3/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Nervous system disorders Headache	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Psychiatric disorders Aggression	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Psychiatric disorders Agitation	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	25.0% 2/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Psychiatric disorders Anxiety	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Psychiatric disorders Panic attack	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Haematuria	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Oliguria	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Renal failure	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Renal and urinary disorders Renal impairment	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	8.3% 1/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	25.0% 5/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	11.8% 2/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	16.7% 2/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	11.8% 2/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	16.7% 2/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Skin and subcutaneous tissue disorders Decubitus ulcer	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Vascular disorders Haematoma	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.9% 1/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Vascular disorders Hypertension	10.0% 2/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	9.1% 2/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	40.0% 2/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Vascular disorders Hypotension	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	5.0% 1/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	4.5% 1/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	11.8% 2/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	12.5% 1/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.
Vascular disorders Jugular vein thrombosis	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/20 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/22 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/17 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/8 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	0.00% 0/12 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.	20.0% 1/5 • From start of treatment (Alteplase) or randomisation (SOC) until the earliest of: Start point + 288 hours or last administration of Alteplase + 168 hours, up to 13 days. Treated Set (TS), included all patients who were randomised and, for patients in the alteplase groups, treated with at least one dose of trial drug.

Additional Information

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Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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