Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01NS044364 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.
Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.
Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.
The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Sulfate | Experimental | Magnesium sulfate (Mg) was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. The bolus-loading dose consisted of 4 grams Mg in 54 ml normal saline. The maintenance infusion contained 16 grams Mg diluted in 240 ml 0.9% normal saline, infused at 10 ml/hr for 24 hours. Paramedics in the field initiated the bolus-loading dose, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose. |
|
| Normal saline | Placebo Comparator | Normal saline was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. Paramedics in the field initiated the bolus-loading dose of 54 ml normal saline, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose at 10 ml/hr for 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale | Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0 No symptoms at all
| 3 months after stroke onset |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Score of 0 or 1 | Minimal or no disability based on the modified Rankin score | 3 months |
| Modified Rankin Score ≤2 | Functional independence based on modified Rankin score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Saver, M.D. | UCLA School of Medicine, Study Overall Principal Investigator | Principal Investigator |
| Sidney Starkman, M.D. | UCLA Stroke Center, Co-Principal Investigator | Principal Investigator |
| Marc Eckstein, M.D. | Los Angeles City Emergency Medical Service, Co-Principal Investigator | Principal Investigator |
| Samuel Stratton, MD | Los Angeles and Orange County Emergency Medical Services Agencies, Co-Principal Investigator | Principal Investigator |
| Frank Pratt, MD | Los Angeles County Emergency Medical Service, Co-Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39011360 | Derived | Kazaryan SA, Shkirkova K, Saver JL, Liebeskind DS, Starkman S, Bulic S, Poblete R, Kim-Tenser M, Guo S, Conwit R, Villablanca P, Hamilton S, Sanossian N. The National Institutes of Health Stroke Scale is comparable to the ICH score in predicting outcomes in spontaneous acute intracerebral hemorrhage. Front Neurol. 2024 Jul 1;15:1401793. doi: 10.3389/fneur.2024.1401793. eCollection 2024. | |
| 38126183 | Derived | Liotta EM, Maas MB, Prabhakaran S, Shkirkova K, Sanossian N, Liebeskind DS, Sharma L, Stratton S, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. Magnesium and Hematoma Expansion in Intracerebral Hemorrhage: A FAST-MAG Randomized Trial Analysis. Stroke. 2024 Feb;55(2):463-466. doi: 10.1161/STROKEAHA.123.043555. Epub 2023 Dec 21. |
| Label | URL |
|---|---|
| The official FAST-MAG Clinical Trial website | View source |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours. |
| FG001 | Magnesium Sulfate | Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours. |
| BG001 | Magnesium Sulfate |
| 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 | Modified Rankin Scale | Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0 No symptoms at all
| Posted | Median | Inter-Quartile Range | units on a scale | 3 months after stroke onset |
|
3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline | Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Saver | UCLA, David Geffen School of Medicine | 310-794-6379 | jsaver@mednet.ucla.edu |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Normal Saline | Drug | Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours. |
|
|
| 3 months |
| NIH Stroke Scale | The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention | 3 months |
| Barthel Index | The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are: FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10) | 3 months |
| Stroke Impact Scale | The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.
| 3 months |
| Serious Adverse Events | 3 months |
| Symptomatic Intracranial Hemorrhage | 3 month |
| Mortality | 3 months |
| 36878722 | Derived | Balucani C, Levine SR, Sanossian N, Starkman S, Liebeskind D, Gornbein JA, Shkirkova K, Stratton S, Eckstein M, Hamilton S, Conwit R, Sharma LK, Saver JL. Neurologic Improvement in Acute Cerebral Ischemia: Frequency, Magnitude, Predictors, and Clinical Outcomes. Neurology. 2023 Mar 7;100(10):e1038-e1047. doi: 10.1212/WNL.0000000000201656. Epub 2022 Dec 7. |
| 36599321 | Derived | Fan S, Jang M, Kim-Tenser M, Shkirkova K, Liebeskind DS, Starkman S, Villablanca JP, Hamilton S, Naidech A, Saver JL, Sanossian N; FAST-MAG Investigators and Coordinators. Effect of Magnesium on Deterioration and Symptomatic Hemorrhagic Transformation in Cerebral Ischemia: An Ancillary Analysis of the FAST-MAG Trial. Cerebrovasc Dis. 2023;52(5):539-542. doi: 10.1159/000528385. Epub 2023 Jan 4. |
| 35380053 | Derived | Naidech AM, Shkirkova K, Villablanca JP, Sanossian N, Liebeskind DS, Sharma L, Eckstein M, Stratton S, Conwit R, Hamilton S, Saver JL; FAST-MAG Investigators and Coordinators. Magnesium Sulfate and Hematoma Expansion: An Ancillary Analysis of the FAST-MAG Randomized Trial. Stroke. 2022 May;53(5):1516-1519. doi: 10.1161/STROKEAHA.121.037999. Epub 2022 Apr 5. |
| 32038463 | Derived | Shkirkova K, Wang TT, Vartanyan L, Liebeskind DS, Eckstein M, Starkman S, Stratton S, Pratt FD, Hamilton S, Kim-Tenser M, Conwit R, Saver JL, Sanossian N. Quality of Acute Stroke Care at Primary Stroke Centers Before and After Certification in Comparison to Never-Certified Hospitals. Front Neurol. 2020 Jan 22;10:1396. doi: 10.3389/fneur.2019.01396. eCollection 2019. |
| 31955642 | Derived | Shkirkova K, Schuberg S, Balouzian E, Starkman S, Eckstein M, Stratton S, Pratt FD, Hamilton S, Sharma L, Liebeskind DS, Conwit R, Saver JL, Sanossian N; FAST-MAG Investigators and Coordinators. Paramedic Global Impression of Change During Prehospital Evaluation and Transport for Acute Stroke. Stroke. 2020 Mar;51(3):784-791. doi: 10.1161/STROKEAHA.119.026392. Epub 2020 Jan 20. |
| 30039165 | Derived | Shkirkova K, Saver JL, Starkman S, Wong G, Weng J, Hamilton S, Liebeskind DS, Eckstein M, Stratton S, Pratt F, Conwit R, Sanossian N; FAST-MAG Trial Coordinators and Investigators. Frequency, Predictors, and Outcomes of Prehospital and Early Postarrival Neurological Deterioration in Acute Stroke: Exploratory Analysis of the FAST-MAG Randomized Clinical Trial. JAMA Neurol. 2018 Nov 1;75(11):1364-1374. doi: 10.1001/jamaneurol.2018.1893. |
| 29301973 | Derived | Chung PW, Kim JT, Sanossian N, Starkmann S, Hamilton S, Gornbein J, Conwit R, Eckstein M, Pratt F, Stratton S, Liebeskind DS, Saver JL; FAST-MAG Investigators and Coordinators. Association Between Hyperacute Stage Blood Pressure Variability and Outcome in Patients With Spontaneous Intracerebral Hemorrhage. Stroke. 2018 Feb;49(2):348-354. doi: 10.1161/STROKEAHA.117.017701. Epub 2018 Jan 4. |
| 28389617 | Derived | Sanossian N, Rosenberg L, Liebeskind DS, Starkman S, Eckstein M, Stratton S, Pratt FD, Hamilton S, Kim-Tenser M, Sharma LK, Restrepo L, Valdes-Suieras M, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. A Dedicated Spanish Language Line Increases Enrollment of Hispanics Into Prehospital Clinical Research. Stroke. 2017 May;48(5):1389-1391. doi: 10.1161/STROKEAHA.117.014745. Epub 2017 Apr 7. |
| 27679533 | Derived | Sanossian N, Apibunyopas KC, Liebeskind DS, Starkman S, Burgos AM, Conwit R, Eckstein M, Pratt F, Stratton S, Hamilton S, Saver JL; FAST-MAG (Field Administration of Stroke Therapy-Magnesium) Investigators and Coordinators. Characteristics and Outcomes of Very Elderly Enrolled in a Prehospital Stroke Research Study. Stroke. 2016 Nov;47(11):2737-2741. doi: 10.1161/STROKEAHA.116.013318. Epub 2016 Sep 27. |
| 26658446 | Derived | Kim DH, Saver JL, Starkman S, Liebeskind DS, Ali LK, Restrepo L, Kim-Tenser M, Valdes-Sueiras M, Eckstein M, Pratt F, Stratton S, Hamilton S, Conwit R, Sanossian N; Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators. Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial. Stroke. 2016 Jan;47(1):232-5. doi: 10.1161/STROKEAHA.115.011687. Epub 2015 Dec 10. |
| 26265130 | Derived | Sanossian N, Liebeskind DS, Eckstein M, Starkman S, Stratton S, Pratt FD, Koenig W, Hamilton S, Kim-Tenser M, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. Routing Ambulances to Designated Centers Increases Access to Stroke Center Care and Enrollment in Prehospital Research. Stroke. 2015 Oct;46(10):2886-90. doi: 10.1161/STROKEAHA.115.010264. Epub 2015 Aug 11. |
| 25651247 | Derived | Saver JL, Starkman S, Eckstein M, Stratton SJ, Pratt FD, Hamilton S, Conwit R, Liebeskind DS, Sung G, Kramer I, Moreau G, Goldweber R, Sanossian N; FAST-MAG Investigators and Coordinators. Prehospital use of magnesium sulfate as neuroprotection in acute stroke. N Engl J Med. 2015 Feb 5;372(6):528-36. doi: 10.1056/NEJMoa1408827. |
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Medical History | Number | participants |
|
| Prestroke function - Living at home | Number | participants |
|
| Los Angeles Motor Scale at hospital arrival | The Los Angeles Motor Scale (LAMS) Facial droop (sub score is 0-1) Absent 0 Present 1 Arm drift (sub score range is 0-2) Absent 0 Drifts down 1 Falls rapidly 2 Grip strength (sub score range is 0-2) Normal 0 Weak grip 1 No grip 2 The sub scales are summed to obtain a total score. Total Score Range is 0-5. Lower values on the scale represent better outcomes and Higher values on the scale represent worse outcomes. | Mean | Standard Deviation | units on a scale |
|
| National Institute of Health Stroke Scale (NIHSS) at hospital arrival | The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention | Mean | Standard Deviation | units on a scale |
|
| Intravenous tissue plasminogen activator (t-PA) in patients with cerebral ischemia | Number | participants |
|
| Final Diagnosis | Number | participants |
|
| OG001 | Magnesium Sulfate | Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours. |
|
|
|
| Secondary | Modified Rankin Score of 0 or 1 | Minimal or no disability based on the modified Rankin score | Posted | Number | participants | 3 months |
|
|
|
|
| Secondary | Modified Rankin Score ≤2 | Functional independence based on modified Rankin score | Posted | Number | participants | 3 months |
|
|
|
|
| Secondary | NIH Stroke Scale | The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
|
|
|
|
| Secondary | Barthel Index | The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are: FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10) | Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
|
|
|
|
| Secondary | Stroke Impact Scale | The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.
| Posted | Median | Inter-Quartile Range | units on a scale | 3 months |
|
|
|
|
| Secondary | Serious Adverse Events | Posted | Number | participants | 3 months |
|
|
|
|
| Secondary | Symptomatic Intracranial Hemorrhage | Posted | Number | participants | 3 month |
|
|
|
|
| Secondary | Mortality | Posted | Number | participants | 3 months |
|
|
|
|
| 422 |
| 843 |
| 331 |
| 843 |
| EG001 | Magnesium Sulfate | Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours. | 439 | 857 | 329 | 857 |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Pericardial haemorrhage | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Syncope | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Torsade de pointes | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Parotitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Pelvic mass | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Accidental poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Cardiac valve replacement complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Device malfunction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Feeding tube complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tracheostomy malfunction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wound necrosis | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Coagulation time prolonged | Investigations | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cardiac myxoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Maxillofacial sinus neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Primitive neuroectodermal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Agitation | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Brain compression | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Brain injury | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Complicated migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cytotoxic oedema | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Neurological decompensation | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Psychosomatic disease | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nephritis interstitial | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Bronchial secretion retention | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Laryngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Carotid endarterectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Cranioplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Craniotomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Endotracheal intubation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Haematoma evacuation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Lung lobectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Medical device implantation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Mitral valve replacement | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Transfusion | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Ventricular drainage | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
|
| Carotid artery dissection | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Gangrene | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Malignant hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Neurogenic shock | Vascular disorders | MedDRA | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA | Systematic Assessment |
|
| Syncope | Vascular disorders | MedDRA | Systematic Assessment |
|
| Vasospasm | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypokalaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |