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This is a randomized, double-blind, placebo-controlled, sequential design, multicentre study in patients with moderately impaired systolic function undergoing CABG surgery. Twenty four (24) patients scheduled for elective bypass surgery will be randomized (up to approximately 33 patients if replacements are needed). The objective is to investigate safety and tolerability of AZD8601 following epicardial injection in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery with moderately impaired systolic function. At Visit 3 patients will receive either AZD8601 or placebo as epicardial injections and will then be followed up at 14 days (telephone visit) and 1, 3 and 6 months (on-site) post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose AZD8601 (3 mg) | Experimental | 8 patients will be randomised to receive 3 mg AZD8601 |
|
| High dose AZD8601 (30 mg) | Experimental | 8 patients will be randomised to receive 30 mg AZD8601 |
|
| Placebo | Placebo Comparator | 8 patients will be randomised to receive placebo injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8601 | Drug | AZD8601 solution for injection, 0,5 mg/mL and 5 mg/mL will be given as 30 injections of 0.1 mg (3 mg per patient), or 1 mg (30 mg per patient) respectively on a single occasion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events | From baseline to end of follow up at 6 months | |
| Pulse Rate (Vital Sign) | From baseline to end of follow up at 6 months | |
| Number of Subjects With an ECG Determined to be Abnormal and Clinically Significant | From baseline to end of follow up at 6 months | |
| Number of Subjects With High Values of Leukocytes, Particle Concentration | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Oxygen Saturation (Vital Sign) | From baseline to end of follow up at 6 months | |
| Systolic Blood Pressure (Vital Sign) | From baseline to end of follow up at 6 months | |
| Number of Subjects With High Values of Erythrocytes, Particle Concentration | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Diastolic Blood Pressure (Vital Sign) | From baseline to end of follow up at 6 months | |
| Number of Subjects With High Values of Erythrocyte, Volume Fraction |
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Inclusion Criteria:
For inclusion in the study patients should fulfil the following criteria at Visit 1 and/or 2:
1. Provision of signed and dated informed consent prior to any study specific procedures
Males and females:
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Previous randomisation in the present study 3. Participation in another clinical study with an investigational product during the last 3 months 4. BMI > 35 kg/m2 OR poor image window for echocardiography 5. Need for CABG emergency operation. (Emergency operation is defined as significant symptom status worsening in CAD, such as crescendo angina, unstable angina or ACS requiring rescheduling the revascularization. CAD should be stable at least 3 months prior to Visit 3.) 6. History of ventricular arrhythmia (≥ Lown III) without Implantable Cardiac Defibrillator (ICD) History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study 8. Severe co-morbidities that can interfere with the execution of the study, interpretation of study results or affect the safety of the patient, in judgement of the investigator 9. eGFR ≤ 30 mL/min (derived from creatinine clearance, calculated by local lab) 10. For CFVR (Visit 1) and sMBF (Visit 2) measurement:
Known severe adverse reactions to adenosine
Known elevated intracranial pressure
AV block ≥ second degree and/or sick sinus syndrome in patient without pacemaker
Heart rate < 40 bpm (ECG verified)
Systolic blood pressure < 90 mmHg
Asthma or COPD with strong reactive component in judgement of investigator
Treatment with dipyridamole (e.g. Persantin or Asasantin), theophyllamine or fluvoxamine that cannot be paused 11. Inability to comply with the protocol 12. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs with a similar chemical structure or class as study drugs 13. Patients unable to give their consent or communicate reliably with the investigator or vulnerable patients e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order 14. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody or human immunodeficiency virus, at Visit 1 15. Known history of drug or alcohol abuse 16. Any concomitant medications that are known to be associated with Torsades de Pointes 17. History of QT prolongation associated with other medications that required discontinuation of that medication 18. Congenital long QT syndrome 19. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3).
20. Current atrial fibrillation as well as paroxysmal atrial fibrillation.
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| Name | Affiliation | Role |
|---|---|---|
| Vesa Anttila, MD, PhD | Heart Center, Turku University, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | New Haven | Connecticut | 06510 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36528793 | Derived | Anttila V, Saraste A, Knuuti J, Hedman M, Jaakkola P, Laugwitz KL, Krane M, Jeppsson A, Sillanmaki S, Rosenmeier J, Zingmark P, Rudvik A, Garkaviy P, Watson C, Pangalos MN, Chien KR, Fritsche-Danielson R, Collen A, Gan LM. Direct intramyocardial injection of VEGF mRNA in patients undergoing coronary artery bypass grafting. Mol Ther. 2023 Mar 1;31(3):866-874. doi: 10.1016/j.ymthe.2022.11.017. Epub 2022 Dec 17. | |
| 32728595 |
| Label | URL |
|---|---|
| CSP redacted | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
The study was to include two dose cohorts, which were to receive a total dose of 3 or 30 mg ofAZD8601. However, due to low recruitment levels, only 7 participants receiving a total dose of 3 mg AZD8601 and 4 participants receiving placebo completed dosing, according to the randomisation scheme
This study was conducted at 4 clinical research centers in Finland and Germany First subject enrolled (First subject first visit/first consent signed date): 2018. Last subject last visit: 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD8601 3mg | AZD8601 3mg |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD8601 3mg | AZD8601 3mg |
| BG001 | Placebo | Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Adverse Events | Posted | Count of Participants | Participants | From baseline to end of follow up at 6 months |
|
|
All adverse events are summarized from the dose of IP to the end the follow-up period at 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD8601 3mg | AZD8601 3mg | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical LEad | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2020 | Jun 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2021 | Jun 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Drug | Placebo for AZ8601 injection for solution will be given as 30 injections per patient on a single occasion |
|
Values are classified as high if they are above the normal reference range, based on local lab reference ranges.
| From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Erythrocytes, Mean Cell Volume | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Hemoglobin | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Neutrophils | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Lymphocytes | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Monocytes | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Eosinophils | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Basophils | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Platelets | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Reticulocytes | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Prothrombin Complex INR | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Activated Partial Thromboplastin Time | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Fibrinogen | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Sodium | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Potassium | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Urea | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Creatinine | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Albumin | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Calcium | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Phosphate | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Alkaline Phosphatase | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Alanine Aminotransferase | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Aspartate Aminotransferase | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Number of Subjects With High Values of Bilirubin, Total | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | From baseline to end of follow up at 6 months |
| Kuopio |
| 70210 |
| Finland |
| Research Site | Tampere | 33520 | Finland |
| Research Site | Turku | 20520 | Finland |
| Research Site | München | 80363 | Germany |
| Research Site | München | 81675 | Germany |
| Research Site | Amsterdam | 1081 HV | Netherlands |
| Research Site | Groningen | 9713 GZ | Netherlands |
| Research Site | Gothenburg | 413 45 | Sweden |
| Research Site | Uppsala | 751 85 | Sweden |
| Derived |
| Anttila V, Saraste A, Knuuti J, Jaakkola P, Hedman M, Svedlund S, Lagerstrom-Fermer M, Kjaer M, Jeppsson A, Gan LM. Synthetic mRNA Encoding VEGF-A in Patients Undergoing Coronary Artery Bypass Grafting: Design of a Phase 2a Clinical Trial. Mol Ther Methods Clin Dev. 2020 Jun 1;18:464-472. doi: 10.1016/j.omtm.2020.05.030. eCollection 2020 Sep 11. |
| SAP redacted | View source |
| CSR synopsis redacted | View source |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Pulse Rate (Vital Sign) | Posted | Mean | Standard Deviation | beats/min | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With an ECG Determined to be Abnormal and Clinically Significant | Posted | Count of Participants | Participants | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Leukocytes, Particle Concentration | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Oxygen Saturation (Vital Sign) | No SD calculated when only one subject in group | Posted | Mean | Standard Deviation | Percent | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Systolic Blood Pressure (Vital Sign) | Posted | Mean | Standard Deviation | mmHg | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Erythrocytes, Particle Concentration | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Diastolic Blood Pressure (Vital Sign) | Posted | Mean | Standard Deviation | mmHg | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Erythrocyte, Volume Fraction | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Erythrocytes, Mean Cell Volume | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Hemoglobin | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Neutrophils | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Lymphocytes | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Monocytes | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Eosinophils | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Basophils | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Platelets | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Reticulocytes | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Prothrombin Complex INR | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Activated Partial Thromboplastin Time | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Fibrinogen | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Sodium | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Potassium | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Urea | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Creatinine | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Albumin | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Calcium | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Phosphate | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Alkaline Phosphatase | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Alanine Aminotransferase | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Aspartate Aminotransferase | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| Primary | Number of Subjects With High Values of Bilirubin, Total | Values are classified as high if they are above the normal reference range, based on local lab reference ranges. | For some participants laboratory analysis have not been made | Posted | Number | Number of subjects | From baseline to end of follow up at 6 months |
|
|
|
| 7 |
| 3 |
| 7 |
| 7 |
| 7 |
| EG001 | Placebo | Placebo | 0 | 4 | 1 | 4 | 4 | 4 |
| Incision site impaired healing | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Incision site inflammation | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
Not provided
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