A Study of the Efficacy and Safety of Alteplase in Partic... | NCT02072226

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alteplase Placebo + Aspirin	Active Comparator	Participants will receive single dose of IV alteplase placebo and aspirin orally.	Drug: Alteplase Placebo Drug: Aspirin
Alteplase + Aspirin Placebo	Experimental	Participants will receive single dose of IV alteplase and aspirin placebo orally.	Drug: Alteplase Drug: Aspirin Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alteplase	Drug	Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).	Alteplase + Aspirin Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90	mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS.	Day 90

Secondary Outcomes

Measure	Description	Time Frame
Distribution of Participants Across the Ordinal mRS	mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death before Day 90. Reported are the percentages of participants for all scores on the mRS.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of less than or equal to(</=) 5 and determined as not clearly disabling by the investigator
Study treatment initiated within 3 hours of last time participant seen normal

Exclusion Criteria:

Computed tomography (CT) or magnetic resonance imaging (MRI) findings of one of the following:
1. CT with clear large hypodensity that is greater than (>) one-third middle cerebral artery (MCA) territory (or >100 cubic centimeter [cc] if not in MCA territory)
2. MRI with clear large hyperintensity on concurrent diffusion-weighted (DW) and fluid-attenuated inversion recovery (FLAIR) that is greater than one-third MCA territory (or greater than 100 cc if not in MCA territory),
3. Imaging lesion consistent with acute hemorrhage, or
4. Evidence of intraparenchymal tumor
Disability prior to the presenting stroke
Standard contraindications to IV alteplase within 3 hours of symptom onset, including:
1. Head trauma, myocardial infarction, or previous stroke within the previous 3 months
2. Gastrointestinal or urinary tract hemorrhage within the previous 21 days
3. Major surgery within the previous 14 days
4. Arterial puncture at non-compressible site within the previous 7 days
5. Any history of ICH with the exception of those less than (<) 5 chronic microbleeds on MRI
6. Elevated blood pressure defined by systolic blood pressure >185 millimeters of mercury (mm Hg) or diastolic blood pressure >110 mm Hg, or treatments requiring aggressive measures to achieve acceptable levels
7. Treatment with unfractioned heparin within past 48 hours and activated partial thromboplastin time outside normal range
8. Blood glucose <50 milligrams per deciliter (mg/dL)
9. International normalized ratio >1.7
10. Platelet count <100,000 per cubic millimeter (/mm^3)
11. Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban, edoxaban) within the last 48 hours
Allergic reaction to study drug, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs)
Females of childbearing age who are known to be pregnant and/or lactating
Inability to swallow, which would prevent oral intake of aspirin or aspirin placebo tablet
Other serious, advanced, or terminal illness that would confound the clinical outcome at 90 days
Current or recent (within 3 months) participation in another investigational drug treatment protocol
Anticipated inability to obtain 3-month follow-up assessments
Previous enrollment in PRISMS
Any other condition deemed by the investigator that would pose hazard to the participant with alteplase treatment

Name	Affiliation	Role
Clinical Trials	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-3300	United States
Banner Good Samaritan Medical Center

PubMed Identifier	Type	Citation	Retractions
29998337	Derived	Khatri P, Kleindorfer DO, Devlin T, Sawyer RN Jr, Starr M, Mejilla J, Broderick J, Chatterjee A, Jauch EC, Levine SR, Romano JG, Saver JL, Vagal A, Purdon B, Devenport J, Pavlov A, Yeatts SD; PRISMS Investigators. Effect of Alteplase vs Aspirin on Functional Outcome for Patients With Acute Ischemic Stroke and Minor Nondisabling Neurologic Deficits: The PRISMS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):156-166. doi: 10.1001/jama.2018.8496.
25638754

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 milligram per kilogram (mg/kg) (maximal dose of 90 mg) intravenous (IV) alteplase and aspirin placebo orally.
FG001	Alteplase Placebo + Aspirin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	May 17, 2017	Mar 6, 2018

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.94± 13.53 BG00161.20± 13.05 BG00261.57± 13.27

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00079 BG00165 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00014 BG00118 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0001 BG0013 BG002

Total National Institutes of Health Stroke Scale (NIHSS)

NIHSS measures stroke symptoms. It has 11 main items which score between 0 and 4. A score of 0 typically indicates normal function, and a higher score indicates more symptoms. The individual scores from each item are summed to calculate total NIHSS score. Total NIHSS score ranges from 0 to 42, with 0 indicating no stroke symptoms, and a higher score indicating more symptoms.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0002.3± 1.21 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90

mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS.

Intent-to-Treat (ITT) population included all randomized participants.

Posted

Number

percentage of participants

Day 90

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units	Counts
Participants	OG000156 OG001157

Title

Denominators

Categories

Title	Measurements
	OG00078.2 OG00181.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Adjusted Risk Difference	-1.10			2-Sided	95	-9.44	7.25					Other	Confidence Interval

Secondary

Distribution of Participants Across the Ordinal mRS

mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death before Day 90. Reported are the percentages of participants for all scores on the mRS.

ITT population included all randomized participants.

Posted

Number

percentage of participants

Day 90

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units	Counts

Secondary

Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS

Global favorable recovery is an integrated assessment of participants who meet the following: mRS Score 0-1, National Institutes of Health Stroke Scale (NIHSS) Score 0-1, Barthel Index [BI] greater than or equal to 95, and Glasgow Outcome Scale [GOS] equal to 1. mRS Score 0-1: 0= No symptoms at all, 1= No significant disability despite symptoms, able to carry out all usual duties and activities. NIHSS Score 0-1: 0= No stroke symptoms and 1= Minor stroke symptoms. BI is a 10 question index with a total score range of 0-100 with 100 being the best outcome. GOS =1: Good recovery. Reported here are the percentages of participants who achieved a favorable score on each of these scales.

ITT population included all randomized participants.

Posted

Number

percentage of participants

Day 90

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units	Counts

Secondary

Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )

ICH was considered symptomatic if it was not seen on computed tomography (CT) or magnetic resonance imaging (MRI) scan at baseline and any neurologic decline was attributed to it by the local investigator. To detect intracranial hemorrhage, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.

Safety Population included all participants, who received any amount of study drug.

Posted

Number

percentage of participants

Within 36 hours after study drug administration on Day 1

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Any ICH

To detect ICH, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.

Safety Population included all participants, who received any amount of study drug.

Posted

Number

percentage of participants

Within 36 hours after study drug administration on Day 1

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units	Counts
Participants	OG000

Secondary

Overall Mortality

Reported here is the percentage of participants who died due to any cause during the study.

Safety Population included all participants, who received any amount of study drug.

Posted

Number

percentage of participants

From baseline to Day 90

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Died Due to Stroke and Neurological Disorders

Reported here is the percentage of participants who died due to stroke and neurological disorders.

Safety Population included all participants, who received any amount of study drug.

Posted

Number

percentage of participants

From baseline to Day 90

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Adverse Events

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

Safety Population included all participants, who received any amount of study drug.

Posted

Number

percentage of participants

From baseline up to Day 90: Non-serious adverse events were collected through the Day 30 visit. Serious adverse events were collected through the end of study at Day 90.

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units

Secondary

Percentage of Participants With Serious Adverse Events

A serious adverse event (SAE) was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Safety Population included all participants, who received any amount of study drug.

Posted

Number

percentage of participants

From baseline to Day 90

ID	Title	Description
OG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
OG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Splenic embolism	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected154 at risk EG0010 affected153 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected154 at risk EG0010 affected153 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0011 affected153 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Retinal detachment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Volvulus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Gait disturbance	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected154 at risk EG0010 affected153 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Fracture displacement	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Haemoglobin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected154 at risk EG0012 affected153 at risk
Stroke in evolution	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected154 at risk EG0011 affected153 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected154 at risk EG0012 affected153 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0013 affected153 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected154 at risk EG0011 affected153 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0011 affected153 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected154 at risk EG0010 affected153 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0012 affected153 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected154 at risk EG0010 affected153 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Embolic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Tremor	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Device loosening	Product Issues	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Renal embolism	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0011 affected153 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected154 at risk EG0011 affected153 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected154 at risk EG0010 affected153 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected154 at risk EG00113 affected153 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected154 at risk EG00110 affected153 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0007 affected154 at risk EG00112 affected153 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected154 at risk EG0019 affected153 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00025 affected154 at risk EG00126 affected153 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG00011 affected154 at risk EG00110 affected153 at risk

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D057057	Serine Proteases
D010960	Plasminogen Activators
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001685	Biological Factors
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Title	Description
BG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.
BG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Alteplase + Aspirin Placebo	Participants received single dose of 0.9 mg/kg (maximal dose of 90 mg) IV alteplase and aspirin placebo orally.	1	154	40	154	49	154
EG001	Alteplase Placebo + Aspirin	Participants received single dose of IV alteplase placebo and 325 mg aspirin orally.	0	153	20	153	53	153