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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS062091 | U.S. NIH Grant/Contract | View source | |
| U01NS061861 | U.S. NIH Grant/Contract | View source | |
| U01NS059041 | U.S. NIH Grant/Contract | View source | |
| U01NS056975 | U.S. NIH Grant/Contract | View source | |
| H23-4-3 | Other Grant/Funding Number | Intramural Research Fund for Cardiovascular Diseases of the National Cerebral and Cardiovascular Center, Japan |
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Planned interim analysis: no significant outcome differences between groups
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Medical University of South Carolina | OTHER |
| Johns Hopkins University | OTHER |
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The specific aims of this study are to:
The report from a National Institute of Neurological Disorders and Stroke Workshop on priorities for clinical research in intracerebral hemorrhage (ICH) in December 2003 recommended clinical trials for evaluation of blood pressure (BP) management in acute ICH as a leading priority. The Special Writing Group of the Stroke Council of the American Heart Association in 1999 and 2007 emphasized the need for clinical trials to ensure evidence-based treatment of acute hypertension in ICH. Consequently, we propose to conduct a five-year international, multicenter, open-labeled, randomized, controlled, Phase III trial to determine the efficacy of early, intensive antihypertensive treatment using intravenous nicardipine for acute hypertension in subjects with co-morbid hypertension and spontaneous supratentorial ICH. The primary hypothesis of this large, streamlined, focused trial is that the group treated with intensive BP reduction (systolic BP [SBP] of 140 mmHg or less - hereafter referred to as the intensive treatment) using intravenous nicardipine infusion for 24 hours reduces the proportion of death and disability at 3 months by 10% or greater compared with the group treated with the standard BP reduction (SBP of 180 mmHg or less - hereafter referred to as the standard treatment) among patients with ICH treated within 4.5 hours of symptom onset. The underlying mechanism for this expected beneficial effect of intensive treatment is mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 38% of patients with acute ICH. The trial will recruit a maximum of 1,280 subjects with ICH who meet the eligibility criteria. The primary outcome is the proportion of death and disability at 3 months defined by modified Rankin scale (mRS) score of 4 to 6. The proposed clinical trial is the natural extension of numerous case series, a subsequent pilot trial funded by the National Institutes of Health National Institute of Health (NIH), and a preliminary randomized controlled trial in this patient group funded by the Australian National Health and Medical Research Council, that have recently confirmed the safety and tolerability of both the regimen and goals of the antihypertensive treatment in acutely hypertensive patients with ICH proposed in the present trial. The proposed trial will have important public health implications by providing necessary information regarding the efficacy and safety of antihypertensive treatment of acute hypertension observed in up to 75% of the subjects with ICH. BP treatment represents a strategy that can be made widely available without the need of specialized equipment and personnel and therefore can make a major impact upon outcome in patients with ICH. Substantial reduction in morbidity and mortality appears possible if the estimates of treatment effect sizes from current pilot trials are accurate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard SBP Reduction Arm | Active Comparator | Intravenous nicardipine hydrochloride will be used as necessary (pro re nata or "PRN") as the primary agent in lowering SBP. The goal for the standard BP reduction group will be to reduce and maintain SBP < 180 mmHg for 24 hours from randomization. 160 mmHg is the target SBP for this arm. For the standard group, SBP below the assigned treatment range is not artificially elevated to stay within the range if lower SBP occurs with nicardipine turned off (no fluid bolus given unless SBP falls below 110 mmHg with nicardipine off and there is risk for hypotension). Euvolemic fluid maintenance is encouraged for all patients according to their medical needs, which may differ. |
|
| Intensive SBP Reduction Arm | Active Comparator | Intravenous nicardipine hydrochloride will be used as necessary (pro re nata or "PRN") as the primary agent in lowering SBP. The goal for the intensive BP reduction group will be to reduce and maintain SBP < 140 mmHg for 24 hours from randomization. 125 mmHg is the target SBP for this arm. For the intensive group, SBP falling below 110 mmHg (lower limit of the assigned treatment range) with nicardipine off is treated with normal saline fluid bolus to prevent or remedy hypotension. Euvolemic fluid maintenance is encouraged for all patients according to their medical needs, which may differ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous nicardipine hydrochloride | Drug | IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP is above the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent may be used (Labetalol 5-20 mg IV bolus every 15 min; diltiazem/urapidil in countries without labetalol) for another hour. Nicardipine infusion is decreased incrementally or is stopped if SBP falls below the desired treatment range. Fluid bolus for SBP still falling below 110 mmHG (millimeters of mercury) with nicardipine off is given to prevent organ hypoperfusion. Vasopressor agents are not used unless symptoms related to or possibly exacerbated by hypoperfusion are present. |
| Measure | Description | Time Frame |
|---|---|---|
| Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization | The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed. | 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores | Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours. | Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language & speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change. |
Inclusion Criteria:
Age 18 years or older
IV nicardipine can be initiated within 4.5 hours of symptom onset.
Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect.
Total Glasgow Coma Scale (GCS) score (aggregate of verbal, eye, and motor response scores) of 5 or greater at time of emergency department (ED) arrival.
International normalized ratio (INR) value < 1.5
CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement <60 cc.
For subjects randomized prior to IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT spontaneous SBP reduction to below 180 mmHg at the time of randomization OR
For subjects randomized after IV antihypertensive administration: SBP greater than 180 mmHg* prior to IV antihypertensive treatment (this includes pre-hospital treatment) AND WITHOUT SBP reduction to below 140 mmHg at the time of randomization.
Informed consent obtained by subject, legally authorized representative, or next of kin.
Exclusion Criteria:
ICH is due to previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.
Intracerebral hematoma considered to be related to trauma.
ICH located in infratentorial regions such as pons or cerebellum.
Intraventricular hemorrhage (IVH) associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles.
Patient to receive immediate surgical evacuation.
Current pregnancy, or parturition within previous 30 days, or active lactation.
Use of dabigatran within the last 48 hours**.
A platelet count less than 50,000 per microliter (µL or mm3)
Known sensitivity to nicardipine.
Pre-morbid disability requiring assistance in ambulation or activities of daily living.
Subject's living will precludes aggressive ICU management.
Subject is currently participating in another interventional clinical trial
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| Name | Affiliation | Role |
|---|---|---|
| Adnan I Qureshi, MD | University of Minnesota | Study Chair |
| Yuko Y Palesch, PhD | Medical University of South Carolina | Study Director |
| Adnan I Qureshi, MD | University of Minnesota | Principal Investigator |
| Yuko Y Palesch, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Stroke Center | Birmingham | Alabama | 35249 | United States | ||
| Maricopa Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20457956 | Background | Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz-Flores S, Ehtisham A, Ezzeddine MA, Goldstein JN, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Study Investigators. Effect of systolic blood pressure reduction on hematoma expansion, perihematomal edema, and 3-month outcome among patients with intracerebral hemorrhage: results from the antihypertensive treatment of acute cerebral hemorrhage study. Arch Neurol. 2010 May;67(5):570-6. doi: 10.1001/archneurol.2010.61. | |
| 19770736 |
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A public use data set from the study database will be made available. A process for sharing subject head imaging studies that may be associated with the data set is under evaluation.
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Consent for participation was obtained from the patient or their allowable representative prior to randomization. All patients randomized were considered as enrolled. Treatment to lower systolic blood pressure (SBP) to the assigned range had to begin within 4.5 hours from symptom onset. Treatment for elevated SBP was not delayed for randomization.
A total of 8,532 patients who presented to enrolling sites for emergency care within 6 hours of symptom onset and were found to have non-traumatic intracerebral hemorrhage (ICH) on head CT imaging were screened for eligibility beginning January 7, 2011. A total of 1000 patients were enrolled in the trial between May 15, 2011 and September 14, 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater then the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| University of Michigan |
| OTHER |
| Neurocritical Care Research Network | UNKNOWN |
| National Cerebral and Cardiovascular Center, Japan | OTHER |
| Japan Cardiovascular Research Foundation | OTHER |
| Beijing Tiantan Hospital | OTHER |
| China Medical University Hospital | OTHER |
| University Hospital Heidelberg | OTHER |
| Seoul National University Hospital | OTHER |
Eligible patients are randomized 1:1 via computer-generated treatment assignment within 4.5 hours of neurological symptom onset to either standard or intensive SBP management using intravenous nicardipine hydrochloride as the primary BP control agent through 24 hours from randomization. Enrolled patients from both treatment arms are otherwise treated similarly after 24 hours, according to their medical needs. Standards of care management for spontaneous intracerebral hemorrhage published in the 2010 American Heart Association guidelines are incorporated in to the study protocol. All enrolled patients are followed through 90 days (± 14 days per protocol window; up to ± 30 days data is used) unless death or withdrawal occurs sooner. Primary analysis based on intent-to-treat (ITT) principles.
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The trial intervention is conducted open-label to avoid concealing clinically necessary patient blood pressure and intravenous drug administration information. Clinical data including SBP values are primarily taken from entries recorded in to the patient's official medical record by hospital staff and are independently monitor-verified. Assessors for the primary outcome (mRS) at 90 days are are unaware of the treatment assignment or in-hospital clinical course of the subjects assessed. De-identified imaging studies are coded independently of subject number so the central imaging reader is unaware of the treatment assignment, clinical findings, or time points of image acquisition for data recorded from imaging. The study (lead) principal investigator and leadership committee members are unable to associate the treatment assignment of subjects to their outcomes or adverse events for purposes of trial decision-making. Adverse events are adjudicated by an independent oversight committee.
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|
| 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization |
| Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.) | Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted. | From the baseline head CT to the 24 +/- 6 hours from randomization head CT |
| From randomization through the 24-hour treatment period |
| Hypotension Within 72 Hours | Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP < 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP < 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization. | From randomization through 72 hours from randomization |
| Treatment-related Serious Adverse Event Within 72 Hours of Randomization | Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. | From randomization through 72 hours (3 days) |
| Any Serious Adverse Event Within the 90-day Study Period | The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data. | From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up. |
| Phoenix |
| Arizona |
| 85008 |
| United States |
| Mayo Clinic Pheonix | Scottsdale | Arizona | 85259 | United States |
| Banner University Medical Center - South Campus | Tuscon | Arizona | 85713 | United States |
| Banner University Medical Center - University Campus | Tuscon | Arizona | 85724 | United States |
| Community Regional Medical Center of Fresno | Fresno | California | 93721 | United States |
| University of California San Diego | La Jolla | California | 92093 | United States |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States |
| Ronald Regan UCLA Medical Center | Los Angeles | California | 90095-9574 | United States |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| Sutter Roseville Medical Center | Roseville | California | 95661 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| UCSF Medical Center | San Francisco | California | 94143 | United States |
| Good Samaritan Hospital | San Jose | California | 95124 | United States |
| Santa Clara Valley Medical Center | Santa Clara | California | 95138 | United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| Yale - New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Christiana Hospital | Newark | Delaware | 19718 | United States |
| University of Florida Gainesville | Gainesville | Florida | 32611 | United States |
| Baptist Medical Center Jacksonville | Jacksonville | Florida | 32207 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| University of South Florida, Tampa General Hospital | Tampa | Florida | 33612 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Eastern Idaho Medical Consultants | Idaho Falls | Idaho | 83404 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Southern Illinois University Memorial Medical Center | Springfield | Illinois | 62794-9643 | United States |
| Lutheran Hospital Indiana | Fort Wayne | Indiana | 46804 | United States |
| Parkview Hospital | Fort Wayne | Indiana | 46805 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky | Lexington | Kentucky | 40536-0296 | United States |
| University of Louisville | Louisville | Kentucky | 40292 | United States |
| West Jefferson Medical Center | Marrero | Louisiana | 70072 | United States |
| Interim LSU Hospital | New Orleans | Louisiana | 70112 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Louisiana State University Health Sciences Center, Shreveport | Shreveport | Louisiana | 71103 | United States |
| Maine Medical Center | South Portland | Maine | 04106 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Wayne State University - Detroit Receiving Hospital | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Sinai-Grace Hospital | Detroit | Michigan | 48235 | United States |
| Allegiance Health | Jackson | Michigan | 49201 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Essentia Health St. Mary's Medical Center | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55404 | United States |
| St. Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Saint Luke's Neuroscience Institute | Kansas City | Missouri | 64111 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| St. Joseph's Regional Medical Center | Clifton | New Jersey | 07012 | United States |
| New Jersey Neuroscience Institute, JFK Medical Center | Edison | New Jersey | 08818 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| New York City Health and Hospitals Corp. / Kings County Hospital | Brooklyn | New York | 11203 | United States |
| Mamoides Medical Center | Brooklyn | New York | 11219 | United States |
| Sister of Charity/Buffalo Mercy Hospital, Catholic Health System | Buffalo | New York | 14214 | United States |
| UHS Wilson Medical Center | Johnson City | New York | 13790 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| SUNY Downstate | New York | New York | 10029 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Lincoln Medical and Mental Health Center | New York | New York | 10451 | United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| Strong Stroke Center | Rochester | New York | 14642 | United States |
| Mission Hospital | Asheville | North Carolina | 28801-4601 | United States |
| Guilford Neurologic Associates | Greenboro | North Carolina | 27405 | United States |
| Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| Novant Clinical Research Institute/Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest Baptist Medical Center (Wake Forest School of Medicine) | Winston-Salem | North Carolina | 27157 | United States |
| Akron General Hospital | Akron | Ohio | 44307 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Ohio State University - Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| Oklahoma University Health Sciences Center (OUHSC) | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Brain and Spine Institute | Portland | Oregon | 97225 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Penn State Univ/ Hershey Med Center | Hershey | Pennsylvania | 17033 | United States |
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC-Mercy Hospital | Pittsburgh | Pennsylvania | 15219 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Wellspan York Hospital | York | Pennsylvania | 17403 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Palmetto Health | Columbia | South Carolina | 29203 | United States |
| Vanderbilt Stroke Center | Nashville | Tennessee | 37232 | United States |
| Seton Medical Center Austin | Austin | Texas | 78705 | United States |
| St. David's Medical Center | Austin | Texas | 78705 | United States |
| University Medical Center Brackenridge | Austin | Texas | 78705 | United States |
| UT Southwestern - Parkland Hospital | Dallas | Texas | 75235 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79430 | United States |
| Valley Baptist Medical Center | Harlingen | Texas | 78550 | United States |
| Memorial Herman - Texas Medical Center | Houston | Texas | 77024 | United States |
| Baylor College of Medicine - Ben Taub Community Hospital | Houston | Texas | 77030 | United States |
| Baylor College of Medicine - St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Methodist Hospital - The Neurological Institute | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298-0631 | United States |
| West Virginia University - Ruby Memorial Hospital | Morgantown | West Virginia | 26506 | United States |
| Medical College of Wisconsin | Milwakee | Wisconsin | 53226 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| University of Alberta | Edmonton | Alberta | 2E3.27WMC | Canada |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | H3A 2B4 | Canada |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Baotou Central Hospital | Baotou | China |
| Beijing Tiantan Hospital | Beijing | 100050 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Datong Third People's Hospital | Datong | China |
| The First Hospital of Shanxi Medical University | Taiyuan | 030001 | China |
| The First People's Hospital of Taizhou | Taizhou | 318020 | China |
| Tianjin Fourth Central Hospital | Tianjin | 300140 | China |
| Wuhan Brain Hospital | Wuhan | 430019 | China |
| Renmin Hospital of Wuhan University | Wuhan | 430060 | China |
| People's Hopital of Zhengzhou | Zhengzhou | 450003 | China |
| Charité Universtity Medicine Berlin | Berlin | 12203 | Germany |
| University of Bonn | Bonn | 53105 | Germany |
| University Hospital Dresden | Dresden | 01307 | Germany |
| Clinic Frankfurt Hoechst | Frankfurt | 65929 | Germany |
| University Hospital Halle | Halle | 06120 | Germany |
| University Hospital Heidelberg | Heidelberg | 69120 | Germany |
| University Hospital Leipzig | Leipzig | 04103 | Germany |
| University Hospital Mannheim | Mannheim | 68167 | Germany |
| University Hospital Meunster | Münster | 48129 | Germany |
| University of Tubingen | Tübingen | 72076 | Germany |
| Nagoya Medical Center | Nagoya | Aichi-ken | 460-0001 | Japan |
| Nakamura Memorial Hospital | Sapporo | Hokkaido | 060-8570 | Japan |
| Saiseikai Yokohamashi Tobu Hospital | Kanagawa | Kanagowa | 230-8765 | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | Kumamoto | 861-4193 | Japan |
| Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Gifu University Hospital | Gifu | 501-1194 | Japan |
| St. Marianna - Toyoko | Kawasaki | 211-0063 | Japan |
| St. Marianna University Hospital | Kawasaki | 216-8511 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Japan |
| Kawasaki Medical School | Okayama | 701-0192 | Japan |
| National Cerebral and Cardiovascular Center | Osaka | 565-8565 | Japan |
| Kohnan Hospital | Sendai | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| Saiseikai Central Hospital - Tokyo | Tokyo | 108-0073 | Japan |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| Kyorin University | Tokyo | Japan |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Kyung Hee University Hospital | Seoul | 130-702 | South Korea |
| Seoul National University Boramae Hospital | Seoul | 156-707 | South Korea |
| Changhua Christian Hospital | Changhua | Taiwan |
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| Taichung Veterans General Hopital | Taichung | 407 | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Shin-Kong Wu Ho-Su Memorial Hospital | Taipei | 111 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Taipei Veteran's Hospital | Taipei | Taiwan |
| Background |
| Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) investigators. Antihypertensive treatment of acute cerebral hemorrhage. Crit Care Med. 2010 Feb;38(2):637-48. doi: 10.1097/CCM.0b013e3181b9e1a5. |
| 18606927 | Background | Qureshi AI. Acute hypertensive response in patients with stroke: pathophysiology and management. Circulation. 2008 Jul 8;118(2):176-87. doi: 10.1161/CIRCULATIONAHA.107.723874. No abstract available. |
| 17356194 | Background | Qureshi AI. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH): rationale and design. Neurocrit Care. 2007;6(1):56-66. doi: 10.1385/ncc:6:1:56. |
| 21626077 | Background | Qureshi AI, Palesch YY. Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale. Neurocrit Care. 2011 Dec;15(3):559-76. doi: 10.1007/s12028-011-9538-3. |
| 22560810 | Background | Qureshi AI, Palesch YY, Martin R, Novitzke J, Cruz Flores S, Ehtisham A, Goldstein JN, Kirmani JF, Hussein HM, Suri MF, Tariq N; Antihypertensive Treatment of Acute Cerebral Hemorrhage Investigators. Systolic blood pressure reduction and risk of acute renal injury in patients with intracerebral hemorrhage. Am J Med. 2012 Jul;125(7):718.e1-6. doi: 10.1016/j.amjmed.2011.09.031. Epub 2012 May 4. |
| 25132910 | Background | Qureshi AI, Palesch YY, Martin R, Toyoda K, Yamamoto H, Wang Y, Wang Y, Hsu CY, Yoon BW, Steiner T, Butcher K, Hanley DF, Suarez JI. Interpretation and Implementation of Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT II). J Vasc Interv Neurol. 2014 Jun;7(2):34-40. No abstract available. |
| 27276234 | Result | Qureshi AI, Palesch YY, Barsan WG, Hanley DF, Hsu CY, Martin RL, Moy CS, Silbergleit R, Steiner T, Suarez JI, Toyoda K, Wang Y, Yamamoto H, Yoon BW; ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network. Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med. 2016 Sep 15;375(11):1033-43. doi: 10.1056/NEJMoa1603460. Epub 2016 Jun 8. |
| 41855454 | Derived | Wang X, Phan TG, Ren X, Ma HH, Li Q, Ouyang M, Delcourt C, Chen X, Wang J, Robinson TG, Arima H, Ma L, Hu X, You C, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Chalmers JP, Song L, Qureshi AI, Anderson C. Systolic Blood Pressure Trajectory and Outcomes in Acute Intracerebral Hemorrhage: Pooled Analysis of the 4 INTERACT and ATACH-II Clinical Trials. Neurology. 2026 Apr 14;106(7):e214671. doi: 10.1212/WNL.0000000000214671. Epub 2026 Mar 19. |
| 39920546 | Derived | Yu B, Melmed KR, Frontera J, Zhu W, Huang H, Qureshi AI, Maggard A, Steinhof M, Kuohn L, Kumar A, Berson ER, Tran AT, Payabvash S, Ironside N, Brush B, Dehkharghani S, Razavian N, Ranganath R. Predicting hematoma expansion after intracerebral hemorrhage: a comparison of clinician prediction with deep learning radiomics models. Neurocrit Care. 2025 Aug;43(1):119-129. doi: 10.1007/s12028-025-02214-3. Epub 2025 Feb 7. |
| 39913881 | Derived | Li Q, Lv X, Morotti A, Qureshi AI, Dowlatshahi D, Falcone GJ, Sheth KN, Shoamanesh A, Murthy SB, Viswanathan A, Goldstein JN. Optimal Magnitude of Blood Pressure Reduction and Hematoma Growth and Functional Outcomes in Intracerebral Hemorrhage. Neurology. 2025 Mar 11;104(5):e213412. doi: 10.1212/WNL.0000000000213412. Epub 2025 Feb 6. |
| 37586882 | Derived | Tsukita K, Sakamaki-Tsukita H, Kaiser S, Zhang L, Messa M, Serrano-Fernandez P, Takahashi R. High-Throughput CSF Proteomics and Machine Learning to Identify Proteomic Signatures for Parkinson Disease Development and Progression. Neurology. 2023 Oct 3;101(14):e1434-e1447. doi: 10.1212/WNL.0000000000207725. Epub 2023 Aug 16. |
| 35513751 | Derived | Qureshi AI, Huang W, Hanley DF, Hsu CY, Martin RH, Malhotra K, Steiner T, Suarez JI, Yamamoto H, Toyoda K. Early Hyperchloremia is Independently Associated with Death or Disability in Patients with Intracerebral Hemorrhage. Neurocrit Care. 2022 Oct;37(2):487-496. doi: 10.1007/s12028-022-01514-2. Epub 2022 May 5. |
| 35400202 | Derived | Tanaka K, Koga M, Fukuda-Doi M, Qureshi AI, Yamamoto H, Miwa K, Ihara M, Toyoda K; ATACH-2 Trial Investigators. Temporal Trajectory of Systolic Blood Pressure and Outcomes in Acute Intracerebral Hemorrhage: ATACH-2 Trial Cohort. Stroke. 2022 Jun;53(6):1854-1862. doi: 10.1161/STROKEAHA.121.037186. Epub 2022 Apr 11. |
| 35022304 | Derived | Tsukita K, Sakamaki-Tsukita H, Takahashi R. Long-term Effect of Regular Physical Activity and Exercise Habits in Patients With Early Parkinson Disease. Neurology. 2022 Feb 22;98(8):e859-e871. doi: 10.1212/WNL.0000000000013218. Epub 2022 Jan 12. |
| 34937780 | Derived | Magid-Bernstein JR, Li Y, Cho SM, Piran PJ, Roh DJ, Gupta A, Shoamanesh A, Merkler A, Zhang C, Avadhani R, Montano N, Iadecola C, Falcone GJ, Sheth KN, Qureshi AI, Rosand J, Goldstein J, Awad I, Hanley DF, Kamel H, Ziai WC, Murthy SB. Cerebral Microbleeds and Acute Hematoma Characteristics in the ATACH-2 and MISTIE III Trials. Neurology. 2022 Mar 8;98(10):e1013-e1020. doi: 10.1212/WNL.0000000000013247. Epub 2021 Dec 22. |
| 34844422 | Derived | Qureshi AI, Huang W, Lobanova I, Chandrasekaran PN, Hanley DF, Hsu CY, Martin RH, Steiner T, Suarez JI, Yamamoto H, Toyoda K. Effect of Moderate and Severe Persistent Hyperglycemia on Outcomes in Patients With Intracerebral Hemorrhage. Stroke. 2022 Apr;53(4):1226-1234. doi: 10.1161/STROKEAHA.121.034928. Epub 2021 Nov 30. |
| 34387101 | Derived | Miwa K, Koga M, Fukuda-Doi M, Yamamoto H, Tanaka K, Yoshimura S, Ihara M, Qureshi AI, Toyoda K. Effect of Heart Rate Variabilities on Outcome After Acute Intracerebral Hemorrhage: A Post Hoc Analysis of ATACH-2. J Am Heart Assoc. 2021 Aug 17;10(16):e020364. doi: 10.1161/JAHA.120.020364. Epub 2021 Aug 13. |
| 34292474 | Derived | Shoamanesh A, Cassarly C, Morotti A, Romero JM, Oliveira-Filho J, Schlunk F, Jessel M, Butcher K, Gioia L, Ayres A, Vashkevich A, Schwab K, Afzal MR, Martin RH, Qureshi AI, Greenberg SM, Rosand J, Goldstein JN; ATACH-2 and NETT investigators. Intensive Blood Pressure Lowering and DWI Lesions in Intracerebral Hemorrhage: Exploratory Analysis of the ATACH-2 Randomized Trial. Neurocrit Care. 2022 Feb;36(1):71-81. doi: 10.1007/s12028-021-01254-9. Epub 2021 Jul 22. |
| 34210824 | Derived | Fukuda-Doi M, Yamamoto H, Koga M, Doi Y, Qureshi AI, Yoshimura S, Miwa K, Ishigami A, Shiozawa M, Omae K, Ihara M, Toyoda K. Impact of Renal Impairment on Intensive Blood-Pressure-Lowering Therapy and Outcomes in Intracerebral Hemorrhage: Results From ATACH-2. Neurology. 2021 Aug 31;97(9):e913-e921. doi: 10.1212/WNL.0000000000012442. Epub 2021 Jul 1. |
| 34144995 | Derived | Yogendrakumar V, Ramsay T, Menon BK, Qureshi AI, Saver JL, Dowlatshahi D. Hematoma Expansion Shift Analysis to Assess Acute Intracerebral Hemorrhage Treatments. Neurology. 2021 Aug 24;97(8):e755-e764. doi: 10.1212/WNL.0000000000012393. Epub 2021 Jun 18. |
| 33219136 | Derived | Toyoda K, Palesch YY, Koga M, Foster L, Yamamoto H, Yoshimura S, Ihara M, Fukuda-Doi M, Okazaki S, Tanaka K, Miwa K, Hasegawa Y, Shiokawa Y, Iwama T, Kamiyama K, Hoshino H, Steiner T, Yoon BW, Wang Y, Hsu CY, Qureshi AI; ATACH-2 Trial Investigators. Regional Differences in the Response to Acute Blood Pressure Lowering After Cerebral Hemorrhage. Neurology. 2021 Feb 2;96(5):e740-e751. doi: 10.1212/WNL.0000000000011229. Epub 2020 Nov 20. |
| 32838673 | Derived | Qureshi AI, Huang W, Lobanova I, Hanley DF, Hsu CY, Malhotra K, Steiner T, Suarez JI, Toyoda K, Yamamoto H; Antihypertensive Treatment of Cerebral Hemorrhage 2 Trial Investigators. Systolic Blood Pressure Reduction and Acute Kidney Injury in Intracerebral Hemorrhage. Stroke. 2020 Oct;51(10):3030-3038. doi: 10.1161/STROKEAHA.120.030272. Epub 2020 Aug 25. |
| 32623977 | Derived | Fukuda-Doi M, Yamamoto H, Koga M, Palesch YY, Durkalski-Mauldin VL, Qureshi AI, Yoshimura S, Okazaki S, Miwa K, Okada Y, Ueda T, Okuda S, Nakahara J, Suzuki N, Toyoda K. Sex Differences in Blood Pressure-Lowering Therapy and Outcomes Following Intracerebral Hemorrhage: Results From ATACH-2. Stroke. 2020 Aug;51(8):2282-2286. doi: 10.1161/STROKEAHA.120.029770. Epub 2020 Jul 6. |
| 32585668 | Derived | Qureshi AI, Foster LD, Lobanova I, Huang W, Suarez JI. Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial. Cerebrovasc Dis. 2020;49(3):244-252. doi: 10.1159/000506358. Epub 2020 Jun 25. |
| 30421455 | Derived | Toyoda K, Koga M, Yamamoto H, Foster L, Palesch YY, Wang Y, Sakai N, Hara T, Hsu CY, Itabashi R, Sato S, Fukuda-Doi M, Steiner T, Yoon BW, Hanley DF, Qureshi AI; ATACH-2 Trial Investigators. Clinical Outcomes Depending on Acute Blood Pressure After Cerebral Hemorrhage. Ann Neurol. 2019 Jan;85(1):105-113. doi: 10.1002/ana.25379. Epub 2019 Jan 7. |
| 30418098 | Derived | Moullaali TJ, Wang X, Martin RH, Shipes VB, Qureshi AI, Anderson CS, Palesch YY. Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage. Int J Stroke. 2019 Apr;14(3):321-328. doi: 10.1177/1747493018813695. Epub 2018 Nov 12. |
| 29789395 | Derived | Qureshi AI, Palesch YY, Foster LD, Barsan WG, Goldstein JN, Hanley DF, Hsu CY, Moy CS, Qureshi MH, Silbergleit R, Suarez JI, Toyoda K, Yamamoto H; ATACH 2 Trial Investigators. Blood Pressure-Attained Analysis of ATACH 2 Trial. Stroke. 2018 Jun;49(6):1412-1418. doi: 10.1161/STROKEAHA.117.019845. Epub 2018 May 22. |
| 29710119 | Derived | Shoamanesh A, Morotti A, Romero JM, Oliveira-Filho J, Schlunk F, Jessel MJ, Ayres AM, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Martin RH, Qureshi AI, Greenberg SM, Rosand J, Goldstein JN; Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) and the Neurological Emergencies Treatment Trials (NETT) Network Investigators. Cerebral Microbleeds and the Effect of Intensive Blood Pressure Reduction on Hematoma Expansion and Functional Outcomes: A Secondary Analysis of the ATACH-2 Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):850-859. doi: 10.1001/jamaneurol.2018.0454. |
| 28701501 | Derived | Morotti A, Boulouis G, Romero JM, Brouwers HB, Jessel MJ, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Greenberg SM, Martin RH, Qureshi AI, Rosand J, Goldstein JN; ATACH-II and NETT investigators. Blood pressure reduction and noncontrast CT markers of intracerebral hemorrhage expansion. Neurology. 2017 Aug 8;89(6):548-554. doi: 10.1212/WNL.0000000000004210. Epub 2017 Jul 12. |
| 28628707 | Derived | Morotti A, Brouwers HB, Romero JM, Jessel MJ, Vashkevich A, Schwab K, Afzal MR, Cassarly C, Greenberg SM, Martin RH, Qureshi AI, Rosand J, Goldstein JN; Antihypertensive Treatment of Acute Cerebral Hemorrhage II and Neurological Emergencies Treatment Trials Investigators. Intensive Blood Pressure Reduction and Spot Sign in Intracerebral Hemorrhage: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2017 Aug 1;74(8):950-960. doi: 10.1001/jamaneurol.2017.1014. |
| 23647568 | Derived | Rodriguez-Luna D, Pineiro S, Rubiera M, Ribo M, Coscojuela P, Pagola J, Flores A, Muchada M, Ibarra B, Meler P, Sanjuan E, Hernandez-Guillamon M, Alvarez-Sabin J, Montaner J, Molina CA. Impact of blood pressure changes and course on hematoma growth in acute intracerebral hemorrhage. Eur J Neurol. 2013 Sep;20(9):1277-83. doi: 10.1111/ene.12180. Epub 2013 May 5. |
| 23230457 | Derived | Toyoda K, Sato S, Koga M, Yamamoto H, Nakagawara J, Furui E, Shiokawa Y, Hasegawa Y, Okuda S, Sakai N, Kimura K, Okada Y, Yoshimura S, Hoshino H, Uesaka Y, Nakashima T, Itoh Y, Ueda T, Nishi T, Gotoh J, Nagatsuka K, Arihiro S, Yamaguchi T, Minematsu K. Run-up to participation in ATACH II in Japan. J Vasc Interv Neurol. 2012 Aug;5(supp):1-5. |
| 22989898 | Derived | Sato S, Yamamoto H, Qureshi AI, Palesch YY, Toyoda K; ATACH-II study group. [Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II at Japan site: study design and advance construction of domestic research network]. Rinsho Shinkeigaku. 2012;52(9):642-50. doi: 10.5692/clinicalneurol.52.642. Japanese. |
| FG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. |
| COMPLETED |
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| NOT COMPLETED |
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Subjects were randomized to standard vs. intensive SBP control. Below-range SBP was not artifically elevated in the standard SBP reduction arm; euvolemic fluid balance was maintained but spontaneous recovery was not prevented. For below-range SBP in the intensive SBP control arm, nicardipine was discontinued and if needed IV fluid bolus was given.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range. |
| BG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity describes persons who have (versus have not) self-identified as being of Cuban, Mexican, Puerto Rican, Cuban, South or Central American, or other Spanish culture or origin, regardless of race. Data are analyzed according to the ethnicity and race of patients included to determine whether there are population differences in health measures or treatment responses that differ. Whether recruitment included an adequate diversity within the affected population is important to understanding the generalizability of results that were obtained and whether further research may be indicated. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race and ethnicity were recorded according to how a person identified themselves, not according to genetic testing or observation. The number of persons who reported American Indian, Alaska Native, Native Hawaiian of other Pacific Islander, or of having origins within more than one race has been included in the "other or unknown" category because the number of persons enrolled in the study from each of these categories was too small to provide a meaningful analysis that would examine these groups individually. Asian race included patients enrolled in Asian countries and non-Asian countries. | Count of Participants | Participants |
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| Recruited at site in Asia | Defined as patients who were enrolled at a clinical site geographically located within regions including Japan, China, Taiwan, or South Korea. Data from these patients were analyzed separately in addition to being part of the full group and other race/ethnicity analyses to examine for potential population differences surrounding intracerebral hemorrhage (ICH) events and recovery that are regional in nature. | Count of Participants | Participants |
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| First Glasgow Coma Scale Score assessed upon hospital emergency department (ED) arrival | The Glasgow Coma Scale (GCS) score is a measure of level of consciousness. The scale quantifies response in three components: eye, motor, and verbal. A lower score indicates a reduced response and a higher score indicates a full response. At least one point is given in each category so the scale ranges from 3 to 15. A score of 3 indicates deep unconsciousness; a higher score indicates milder impairment of consciousness. The maximum score of 15 indicates consciousness is not impaired but other neurological symptoms may still be present. Estimated verbal scoring was used for intubated patients. | Count of Participants | Participants |
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| Systolic Blood Pressure at presentation in hospital emergency department (ED) | Blood pressure is reported as the systolic (systolic blood pressure or "SBP") reading "over" the diastolic (or DBP) reading, and is measured in millimeters of mercury (mmHg) on a gauge. SBP is a measure of the force pressing against the blood vessels when the heart contracts to push blood out to the body, and was considered most important for this study. DBP measures lingering pressure within the blood vessels as the heart fills with newly-oxygenated blood from the lungs. Hospitals selected the method that they felt was the most accurate way to report systolic blood pressures for each patient. | Data were missing for 1 patient in the standard-treatment group. It was permissible for pre-arrival or post-admission qualifying SBP to be used in eligibility determination if all other criteria were met. | Mean | Standard Deviation | mmHg |
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| Median NIHSS score (range) | The National Institutes of Health Stroke Scale (NIHSS) is a serial measure of neurologic deficit (problems in function). It uses a scale (range 0 - 42) to quantify neurologic deficits in 11 categories. The categories are measured by asking questions that indicate the patient's level of consciousness, then testing horizontal eye movements, visual fields, facial palsy, movement in each limb, sensation, language and speech, and extinction or inattention on one side of the body. A score of 0 indicates normal function without neurologic deficit. Higher scores indicate greater severity of deficit. | Median | Full Range | units on a scale (NIHSS range 0 - 42) |
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| Intracerebral Hematoma Volume | Hematoma volumes are reported in cubic centimeters (cm3), as measured by the central reader. The area of the hematoma on head CT imaging was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. The central reader and those performing manual correction were unaware of the patient identities, treatment assignments, clinical findings, and time points of image acquisition. The software provided total volume measurements by summing up volumes (product of area and slice thickness) from all the slices containing the hematoma. | A precise measure of bleeding within the brain was occasionally unable to be determined or baseline imaging wasn't submitted for analysis before data lock. This measure was missing for 8 patients in the standard treatment group and 4 in the intensive group. For eligibility, hematoma volume was estimated rapidly in 3 dimensions (ABC/2) at bedside. | Median | Full Range | cubic centimeters (cm3) |
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| Intracerebral hematoma volume greater than 30 cm3 | Hematoma volumes are reported in cubic centimeters (cm3), as measured by the central reader. The area of the hematoma on head CT imaging was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. The central reader and those performing manual correction were unaware of the patient identities, treatment assignments, clinical findings, and time points of image acquisition. The software provided total volume measurements by summing up volumes (product of area and slice thickness) from all the slices containing the hematoma. | A precise measure of bleeding within the brain was occasionally unable to be determined or baseline imaging wasn't submitted for analysis before data lock. This measure was missing for 8 patients in the standard treatment group and 4 in the intensive group. For eligibility, hematoma volume was estimated rapidly in 3 dimensions (ABC/2) at bedside. | Count of Participants | Participants |
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| Intraventricular Hemorrhage | Intraventricular hemorrhage is bleeding that is present within the ventricles, or internal fluid-filled spaces, within the brain. These spaces are usually filled with cerebrospinal fluid that also circulates around the brain and spinal column, which helps to protect and cushion the delicate brain tissue. In this study, when intraventricular hemorrhage was present it meant that bleeding had extended from another region within the brain tissue to also being present in the brain ventricles. Intraventricular blood is associated with other complications and may indicate a more severe condition. | The presence of blood within a brain ventricle as opposed to the hematoma (blood clot) within surrounding brain tissue pressing in to the ventricular space occasionally can't be determined, or baseline imaging wasn't submitted for analysis. This measure was missing for 8 patients in the standard treatment group and 4 in the intensive group. | Count of Participants | Participants |
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| Location of Hemorrhage | The primary location of hemorrhage (bleeding) in the brain tissue was recorded as being located in the basal ganglia, thalamus, or a lobar region on either the right or left side of the brain. One patient was included that had a cerebellar hemorrhage, which means that bleeding was in the lower dorsal (back) region of the brain. | The primary location of bleeding within the brain is occasionally unable to be clearly determined, or baseline imaging wasn't submitted for analysis. This measure was missing for 8 patients in the standard treatment group and 4 in the intensive group. | Count of Participants | Participants |
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| Prior stroke/transient ischemic attack | Count of Participants | Participants |
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| Other prior nervous system disorders | Count of Participants | Participants |
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| History of congestive heart failure | Count of Participants | Participants |
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| History of atrial fibrillation | Count of Participants | Participants |
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| Myocardial infarction in the previous 3 months | Count of Participants | Participants |
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| History of coronary artery disease | Count of Participants | Participants |
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| History of hypertension | Count of Participants | Participants |
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| History of peripheral vascular disease | Count of Participants | Participants |
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| History of hyperlipidemia | Count of Participants | Participants |
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| History of cardiac dysrhythmias | Count of Participants | Participants |
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| History of diabetes mellitus Type 2 | Count of Participants | Participants |
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| Previous use of antihypertensive drugs | Count of Participants | Participants |
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| Symptom onset to randomization time, minutes | Mean | Standard Deviation | minutes |
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| Symptom onset to nicardipine infusion time | To qualify, patients had to have SBP greater than 180 mmHg prior to antihypertensive treatment and SBP not below 140 mmHg at the time of randomization. Nicardipine infusion had to be able to start within 4.5 hours of symptom onset. In accordance with recommendations, treatment of significant hypertension in patients presenting with ICH was not delayed for consent and randomization. This measure captures the earliest nicardipine start time but other intravenous antihypertensive medications may have been given before then. "Zero" nicardipine start rates may not have been recorded in all cases. | Data from 24 (3 intensive and 21 standard arm) patients was missing. If nicardipine wasn't needed to achieve the assigned SBP range at the time of randomization, more common in the standard arm, nicardipine was initiated at zero rate. "Zero rate" IV infusions have less consistent recording. Some patients had SBP within range without nicardipine. | Mean | Standard Deviation | minutes |
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| Mean minimum systolic blood pressure, during the first 2 hours post randomization | Data were missing for 3 subjects in the standard treatment arm. If a vasoactive IV drip medication (such as nicardipine) is not in use, then standard-of-care parameters for close monitoring of SBP are different (frequency of required monitoring is less). Patient transfer and some procedures can preclude vigilance in recording research-only SBP. | Mean | Standard Deviation | mmHg |
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| Failure to attain systolic blood pressure target within 2 hours | Elevation of systolic blood pressure is common with intracerebral hemorrhage. Recovery of normalized blood pressure may occur quickly for some patients and only after an extended time for others, and more or less medication may be needed. The systolic blood pressure goal is usually achieved incrementally, as antihypertensive medication begins to take effect to control blood pressure. A lower target SBP range may take longer or be more difficult to achieve. The goal in this study was to achieve blood pressure control within 2 hours of randomization for all patients, regardless of treatment arm. | Count of Participants | Participants |
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| Failure to attain systolic blood pressure target for 2 consecutive hours during 2-24 hours | This data parameter is a measure of the success (or lack of success) with which SBP control to the assigned treatment range was consistently maintained during the 24-hour SBP control study period. | Count of Participants | Participants |
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| 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 | Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization | The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed. | All subjects were analyzed for known death at any time following randomization. Patients surviving through 90 days (± 14 days per protocol window; data used up to ± 30 days) were assessed for disability using the mRS. Patients not completing the 90-day visit within 30 days of due date aren't included in the death & disability participant counts. | Posted | Count of Participants | Participants | 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization |
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| Secondary | Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores | Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view. | All available valid data were analyzed. Outcomes collected outside of 90 ± 30 days weren't considered valid. EQ-5D data were missing for 28 patients in the intensive group & for 27 in the standard group. EQ VAS data were missing for 144 patients in the intensive group and for 146 in the standard group. | Posted | Median | Full Range | units on a scale | 90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization |
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| Secondary | Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.) | Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted. | Participants with readable head CTs at baseline and 24 +/- 6 hours from randomization (submitted before data lock) were analyzed. Hematoma expansion was only recorded as present if ≥ 33% volume increase was calculated. Scans done outside of time window + margin, submitted after data lock, or not readable in standard DICOM format could not be used. | Posted | Count of Participants | Participants | From the baseline head CT to the 24 +/- 6 hours from randomization head CT |
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| Other Pre-specified | Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours. | Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language & speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change. | All subjects were assessed for neurological status regularly. Grid-estimated verbal scoring based on eye and motor scores was used for intubated patients so that GCS scores could be compared over time and was consistent across patients. | Posted | Count of Participants | Participants | From randomization through the 24-hour treatment period |
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| Other Pre-specified | Hypotension Within 72 Hours | Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP < 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP < 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization. | Blood pressure including the potential for hypotension was monitored according to intensive care unit standards for ICH patients during early hospitalization. Blood pressure was monitored more closely during the 24-hour study period and at times when nicardipine (or other/secondary IV antihypertensive medications) were being titrated. | Posted | Count of Participants | Participants | From randomization through 72 hours from randomization |
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| Other Pre-specified | Treatment-related Serious Adverse Event Within 72 Hours of Randomization | Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. | Relatedness is defined by the terms unrelated, unlikely, possibly, probably, or definitely related to the study treatment. Results are entered as the count of participants experiencing any serious adverse event within 72 hours of randomization that was determined by the site investigator to possibly or more have relationship to the study treatment. | Posted | Count of Participants | Participants | From randomization through 72 hours (3 days) |
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| Other Pre-specified | Any Serious Adverse Event Within the 90-day Study Period | The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data. | Patients may have experienced more than one adverse event. This measure is designed to show the total count of any patients who experienced any type of serious adverse event, whether it was felt to be related to the study treatment or not, throughout the duration of their participation in the study. | Posted | Count of Participants | Participants | From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up. |
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Adverse events were collected between randomization and the end-of-study visit. All adverse events (defined as abnormal test results, new diagnoses, worsening of conditions, or other health events of clinical significance) were collected through day 7 or hospital discharge, whichever came first. Only serious adverse events (SAEs) were collected from Day 7 (or discharge, if sooner) through final study visits at 3-months +/- 30 days. SAEs, 5-day reporting timeline.
Adverse events during hospitalization: assessed from medical records. Post-hospital discharge, patients/proxy were asked if illness or hospitalization had occurred; available medical records also checked. CTCAE v. 4.03 as severity grading reference. Relatedness of adverse events: assessed by the site investigator within categories unrelated, unlikely, possibly, probably, or definitely related to the study treatment. Analyses by code + related safety groupings. AEs ≩ all subjects being affected.
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 | Standard SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range. | 100 | 500 | 500 | 500 | ||
| EG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. | 128 | 500 | 500 | 500 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angiopathy | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under vascular disorders, also analyzed with cardiac disorders for safety |
|
| Aphasia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood creatinine increased | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under investigations, also analyzed with renal disorders for safety |
|
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| CNS ventriculitis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria); coded under general disorders, also analyzed with cardiac disorders for safety |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Cranioplasty | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cyst aspiration | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Device related infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Drug withdrawal syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Haemorrhagic infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Hydrocephalus | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Hypertension | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria); coded under general disorders, also analyzed with cardiac disorders for safety |
|
| Hypertensive crisis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under vascular disorders, also analyzed with cardiac disorders for safety |
|
| Hypertensive emergency | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under vascular disorders, also analyzed with cardiac disorders for safety |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Hypotension | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Ischaemia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under vascular disorders, also analyzed with brain infarct/nervous disorders for safety |
|
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Liver function test abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Lung infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Meningitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Mental impairment | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Mental status changes | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Oxygen saturation decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Pulseless electrical activity | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Respiratory rate increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Stroke in evolution | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subdural haematoma evacuation | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Subdural hygroma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (Meeting SAE criteria) |
|
| Urosepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abscess limb | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Administration site reaction | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aortic stenosis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under vascular disorders, also analyzed with cardiac disorders for safety |
|
| Arteriosclerosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood chloride abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood chloride increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood creatinine abnormal | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under investigations, also analyzed with renal disorders for safety |
|
| Blood creatinine decreased | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under investigations, also analyzed with renal disorders for safety |
|
| Blood creatinine increased | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) Coded under investigations, also analyzed with renal disorders for safety. |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood pressure decreased | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood pressure diastolic increased | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under investigations, also analyzed with cardiac disorders for safety |
|
| Blood pressure increased | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under investigations, also analyzed with cardiac disorders for safety |
|
| Blood sodium increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood urea decreased | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood urea increased | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Brain oedema | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Brain stem infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Cardiac murmur | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebral haematoma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Cerebral infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Chest discomfort | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria); coded under general disorders, also analyzed with cardiac disorders for safety |
|
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Clostridial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coma scale abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Consciousness fluctuating | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Craniotomy | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dacryocystitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Delirium | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Delirium tremens | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Depressed mood | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Electrocardiogram ST segment depression | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under investigations, also analyzed with cardiac disorders for safety |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Endotracheal intubation | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Enterocolitis viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Extrasystoles | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fluid overload | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastric occult blood positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrostomy tube insertion | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Glomerular filtration rate increased | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under investigations, also analyzed with renal disorders for safety |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Haemoglobin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Hallucination | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic cyst | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperhomocysteinaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety |
|
| Hypervolaemia | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under metabolism and nutrition disorders, also analyzed with renal disorders for safety |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety |
|
| Hypovolaemia | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Coded under metabolism and nutrition disorders, also analyzed with renal disorders for safety |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| IIIrd nerve paralysis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Incontinence | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intracranial haematoma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Loss of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Macular oedema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Mental impairment | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Mental status changes | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Neurological symptom | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| PO2 decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Pneumocephalus | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post transfusion purpura | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Procalcitonin increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Pyelonephritis chronic | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Renal function test abnormal | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Retinopathy hypertensive | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Scleral oedema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Seizure like phenomena | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
|
| Speech disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Sputum culture positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Sputum increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Stereotactic surgery | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
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| Streptococcus test positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Stress ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
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| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
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| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Tongue oedema | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Tracheobronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Troponin I increased | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Troponin increased | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | (AE Not meeting SAE criteria) |
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| Urinary tract infection fungal | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Urine output decreased | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vasogenic cerebral oedema | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vena cava thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Venous thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Venous thrombosis limb | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Ventricular hypertrophy | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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Treatment failures, randomization window, demographics, pre-randomization treatment, low death/disability, favorable baselines, and early termination could limit generalizability of primary (all with intent-to-treat) results and some sub-analyses.
The overall Principal Investigator IS, but the Data Coordination Unit (statistical) Principal Investigator IS NOT employed by the sponsor. Prior to release of a public-use data set, any study PIs/other collaborators may submit a proposal requesting data access, assistance with statistical analyses, and publication of additional results. All proposals are reviewed by a Publications Committee that includes the primary study PI, the statistical PI, the NINDS project scientist, and appointed others.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adnan I. Qureshi, MD | University of Minnesota | 612-624-2431 | qureshai@gmail.com |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009529 | Nicardipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).
The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).
Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.
If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range.
| OG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. |
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Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range. |
| OG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. |
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| OG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. |
|
|
| OG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. |
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| OG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. |
|
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| OG001 | Intensive SBP Reduction Arm | Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP). The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg). Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension. |
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