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To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FlowTriever Arm | FlowTriever Arm subjects are defined as those subjects where FlowTriever is used as the Primary Treatment for pulmonary embolism. | ||
| Context Arm | Subjects with high-risk pulmonary embolism who are treated with non-FlowTriever therapies. | ||
| Prior Therapy Arm | Subjects presenting with low/intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding | The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%. Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Incidence of mortality | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Bailout to an Alternative Thrombus Removal Strategy |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Length of post-treatment hospital stay, measured in number of overnights | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Length of ICU Stay |
Inclusion Criteria:
Age >=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions
Exclusion Criteria:
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Patients with high-risk (massive) pulmonary embolism.
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Silver, MD | OhioHealth Riverside | Principal Investigator |
| James Horowitz, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30308 | United States | ||
| Beaumont Royal Oak |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37847768 | Result | Silver MJ, Gibson CM, Giri J, Khandhar S, Jaber W, Toma C, Mina B, Bowers T, Greenspon L, Kado H, Zlotnick DM, Chakravarthy M, DuCoffe AR, Butros P, Horowitz JM. Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study. Circ Cardiovasc Interv. 2023 Oct;16(10):e013406. doi: 10.1161/CIRCINTERVENTIONS.123.013406. Epub 2023 Oct 17. |
| Label | URL |
|---|---|
| Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study | View source |
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Subjects who met eligibility criteria for the study and had a primary thrombus removal strategy initiated were enrolled into either the FlowTriever, Context or Prior Therapy Arm, based on the thrombus removal strategy initiated. These three arms were non-randomized parallel registries.
All patients presenting to the hospital/emergency department with PE or who incidentally develop PE while in the hospital were assessed for high-risk PE, and for eligibility for enrollment in the FLAME study.
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| ID | Title | Description |
|---|---|---|
| FG000 | FlowTriever Arm | Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE |
| FG001 | Context Arm | Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy [0%], anticoagulation alone [23.0%] systemic thrombolysis [68.9%], catheter-directed thrombolysis [6.6%], or surgical thrombectomy [1.6%] |
| FG002 | Prior Therapy Arm | Subjects presenting with low or intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FlowTriever Arm | Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE. |
| BG001 | Context Arm | Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy [0%], anticoagulation alone [23.0%], systemic thrombolysis [68.9%], catheter-directed thrombolysis [6.6%], or surgical thrombectomy [1.6%]) |
| 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 | Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding | The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%. Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | All patients in the FlowTriever Arm and Context Arm. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
Adverse Events were collected from time of enrollment through hospital discharge (or through day 45, whichever occurred first)
The study only captured AEs related to the subject's PE condition and treatment. Reportable AEs included all events considered in the safety analyses, all thrombus removal therapy/device- and/or procedure-related AEs, as well as events resulting in death. For the Prior Therapy arm, safety data were collected but not CEC adjudicated or analyzed.
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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 | FlowTriever Arm | Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashleigh Willson | Inari Medical | 925-330-3446 | ashleigh.willson@inarimedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2020 | Nov 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2020 | May 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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Incidence of bailout to an alternative thrombus removal strategy
| From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Clinical Deterioration | Incidence of clinical deterioration | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Major Bleeding | Incidence of major bleeding | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Frequency of Stroke | Incidence of ischemic or hemorrhagic stroke | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Device-related Complications | Incidence of device-related complications | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Access Site Injury Requiring Intervention, Both Venous and Arterial | Incidence of access site injury requiring intervention, including both venous and arterial | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
Length of post-treatment ICU stay, measure in number of overnights
| From treatment start or ICU admission, whichever is later, to ICU discharge |
| Use of ECMO | Frequency of ECMO use, including either pre or post treatment initiation | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Discharge Location | Discharge location after hospital stay | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
| Time to Extubation | Time to extubation reported as number of days | From the time of initiation of primary treatment to extubation |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| Ascension Providence Hospital | Southfield | Michigan | 48075 | United States |
| Gates Vascular Institute / SUNY Buffalo | Buffalo | New York | 14203 | United States |
| Lenox Hill Hospital / Northwell Health | New York | New York | 10075 | United States |
| OhioHealth Riverside | Columbus | Ohio | 43214 | United States |
| Penn Presbyterian/Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Lankenau Medical Center / Pulmonology Associates | Wynnewood | Pennsylvania | 19076 | United States |
| Inova Fairfax | Falls Church | Virginia | 22042 | United States |
| BG002 | Prior Therapy Arm | Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Of the "Unknown or Not Reported" Races; 4 were not provided in FlowTriever Arm, 2 were not provided in the Context Arm, and 1 was not provided in the Prior Therapy Arm. Additionally, 1 Context Arm Race was reported as "Other" | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | All-Cause Mortality | Incidence of mortality | All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Secondary | Bailout to an Alternative Thrombus Removal Strategy | Incidence of bailout to an alternative thrombus removal strategy | All patients in the FlowTriever and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Secondary | Clinical Deterioration | Incidence of clinical deterioration | All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Secondary | Major Bleeding | Incidence of major bleeding | All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Secondary | Frequency of Stroke | Incidence of ischemic or hemorrhagic stroke | All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Secondary | Device-related Complications | Incidence of device-related complications | All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Secondary | Access Site Injury Requiring Intervention, Both Venous and Arterial | Incidence of access site injury requiring intervention, including both venous and arterial | All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects. | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Other Pre-specified | Length of Hospital Stay | Length of post-treatment hospital stay, measured in number of overnights | All patients in FlowTriever, Context and Prior Therapy Arms who survived to discharge or 45 days, whichever comes first. | Posted | Median | Inter-Quartile Range | Days | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Other Pre-specified | Length of ICU Stay | Length of post-treatment ICU stay, measure in number of overnights | All patients in the FlowTriever, Context and Prior Therapy Arms who survived to discharge or study exit | Posted | Median | Inter-Quartile Range | Days | From treatment start or ICU admission, whichever is later, to ICU discharge |
|
|
|
| Other Pre-specified | Use of ECMO | Frequency of ECMO use, including either pre or post treatment initiation | All patients in FlowTriever, Context and Prior Therapy Arms | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Other Pre-specified | Discharge Location | Discharge location after hospital stay | All patients in the FlowTriever, Context and Prior Therapy Arms | Posted | Count of Participants | Participants | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. |
|
|
|
| Other Pre-specified | Time to Extubation | Time to extubation reported as number of days | All patients in the FlowTriever Arm, Context Arm and Prior Therapy arm who survived to discharge or study exit, underwent a single intubation procedure prior to initiation of primary treatment, and were extubated prior to and through discharge or study exit | Posted | Median | Inter-Quartile Range | Days | From the time of initiation of primary treatment to extubation |
|
|
|
| 1 |
| 53 |
| 16 |
| 53 |
| 10 |
| 53 |
| EG001 | Context Arm | Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy [0%], anticoagulation alone [23.0%], systemic thrombolysis [68.9%], catheter-directed thrombolysis [6.6%], or surgical thrombectomy [1.6%]) | 18 | 61 | 37 | 61 | 19 | 61 |
| EG002 | Prior Therapy Arm | Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently processed to high-risk PE in the same hospital setting/admission | 1 | 1 | 1 | 1 | 0 | 1 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Arterial haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Brain Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Breast haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Chest wall haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haemodynamic instability | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Obstructive shock | Vascular disorders | MedDRA | Systematic Assessment |
|
| Orbital haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pulmonary haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Swelling | General disorders | MedDRA | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Tooth socket haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Worsening Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Worsening Shock Liver | Investigations | MedDRA | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haemodynamic instability | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pelvic haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
|
| Skin haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Tongue biting | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tongue haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
|
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
| Care facility/skilled nursing home |
|
| Stayed in hospital for >/= 45 days |
|
| Expired prior to discharge |
|
| Other |
|