Albumin in Acute Ischemic Stroke Trial | NCT00235495

ID	Type	Description	Link
U01NS054630	U.S. NIH Grant/Contract		View source
NIH NINDS 5U01 NS040406-08	Other Identifier	Internal tracking number
20060233	Other Identifier	Western IRB

Status Module

Name	Class
National Institute of Neurological Disorders and Stroke (NINDS)	NIH
University of Calgary	OTHER
Medical University of South Carolina	OTHER

Description Module

Label	Type	Description	Intervention Names
Albumin (ALB)	Active Comparator	Albumin (human albumin, 25% solution, 2.0 g/kg), infused intravenously over a period of 2 hours	Biological: Albumin
Saline	Placebo Comparator	Saline (isotonic solution), 8 ml/kg, infused intravenously over a 2-hour period	Drug: Saline

Name	Type	Description	Arm Group Labels	Other Names
Albumin	Biological	human albumin, 25%, 2.0g/kg intravenously (or equivalent volume of saline control), infused over 2 h, commencing within 5 hours of stroke onset	Albumin (ALB)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Participants With Favorable Outcome Defined as National Institute of Health Stroke Scale (NIHSS) Score of 0-1 and/or Modified Rankin Scale (mRS) of 0-1.	The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit. The mRS ranges from 0-6 representing perfect health without symptoms to death. A score of 0 is no symptoms at all and a score of 1 is no significant disability. Able to carry out all usual duties and activities.	at 3 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With a Composite Outcome of mRS 0-1 and/or NIHSS 0-1 and/or Decrease in NIHSS From Baseline by 10 or More Points		at 3 months
Number of Participants With a NIHSS of 0-1 at 24 Hours	The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute ischemic stroke
NIH stroke scale score > 5
Age >= 18 and <= 83
ALB or placebo can be administered within 5 hours of symptom onset
ALB or placebo can be administered within 60 minutes of Tissue Plasminogen Activator (tPA) administration in the thrombolysis group
Signed informed consent

Exclusion Criteria:

Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. An episode of congestive heart failure is any heart failure that required a change in medication, diet or hospitalization.
Known valvular heart disease with CHF in the last 6 months.
Severe aortic stenosis or mitral stenosis.
Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months.
Acute myocardial infarction in the last 6 months.
Signs or symptoms of acute myocardial infarction, including ECG findings, on admission.
Baseline elevated serum troponin level on admission (>0.1 mcg/L)
Suspicion of aortic dissection on admission.
Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability.
Findings on physical examination of any of the following: (1) jugular venous distention (JVP > 4 cm above the sternal angle); (2) 3rd heart sound; (3) resting tachycardia (heart rate > 100/min) attributable to congestive heart failure; (4) abnormal hepatojugular reflux; (5) lower extremity pitting edema attributable to congestive heart failure; and/or (6) definite chest x-ray evidence of pulmonary edema.
Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
Historical Modified Rankin Score (mRS) ≥2. Patients who live in a nursing home or who are not fully independent for activities of daily living immediately prior to the stroke are not eligible for the trial.
In-patient stroke. I.e., patients with a stroke occurring as a complication of hospitalization for another condition, or as a complication of a procedure.
Planned acute use of intra-arterial (IA) tPA or acute endovascular intervention (e.g., stenting, angioplasty, thrombus retrieval device use) must conform to the following criteria: (1) begin within 5 hours of symptom onset, and (2) finish within 7 hours of symptom-onset.
Fever, defined as core body temperature > 37.5° C (99.5°F).
Serum creatinine > 2.0 mg/dL or 180 µmol/L.
Profound dehydration.
Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
History of allergy to albumin.
History of latex rubber allergy.
Severe chronic anemia with Hgb < 7.5 g/dL
Pregnancy, breastfeeding or positive pregnancy test. (Women of childbearing age must have a negative pregnancy test prior to ALB administration.)
Concurrent participation in any other therapeutic clinical trial.
Evidence of any other major life-threatening or serious medical condition that would prevent completion of 3-month follow-up, impair the assessment of outcome, or in which ALB therapy would be contraindicated or might cause harm to the subject.

Name	Affiliation	Role
Myron D. Ginsberg, MD	University of Miami	Study Chair
Michael D. Hill, MD MSc	University of Calgary	Principal Investigator
Yuko Y Palesch, PhD	Medical University of South Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Hospital		Phoenix	Arizona	85054	United States
University of Arizona Medical Center-South Campus

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27462118	Derived	Martin RH, Yeatts SD, Hill MD, Moy CS, Ginsberg MD, Palesch YY; ALIAS Parts 1 and 2 and NETT Investigators. ALIAS (Albumin in Acute Ischemic Stroke) Trials: Analysis of the Combined Data From Parts 1 and 2. Stroke. 2016 Sep;47(9):2355-9. doi: 10.1161/STROKEAHA.116.012825. Epub 2016 Jul 26.
26325387	Derived	Hill MD, Martin RH, Palesch YY, Moy CS, Tamariz D, Ryckborst KJ, Jones EB, Weisman D, Pettigrew C, Ginsberg MD. Albumin Administration in Acute Ischemic Stroke: Safety Analysis of the ALIAS Part 2 Multicenter Trial. PLoS One. 2015 Sep 1;10(9):e0131390. doi: 10.1371/journal.pone.0131390. eCollection 2015.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
FG001	Saline	Treatment with same volume of normal saline

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0001 BG0010 BG0021
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.42± 12.95 BG00164.84± 12.88 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000202 BG001184 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00024 BG00126 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian/Alaska Native/First Nations People	BG0002 BG0010 BG002

Oxfordshire Community Stroke Project Classification

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Total Anterior Circulation Syndrome	BG000102 BG00198 BG002

Baseline National Institutes of Health Stroke Scale (NIHSS) Score

Median

Inter-Quartile Range

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00011(8 to 17) BG001

Baseline ASPECTS

Number

Participants

Title

Denominators

Categories

Baseline ASPECTS >7

Title	Measurements
	BG000325 BG001327 BG002

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

The Number of Participants With Favorable Outcome Defined as National Institute of Health Stroke Scale (NIHSS) Score of 0-1 and/or Modified Rankin Scale (mRS) of 0-1.

The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of greater than 20 indicating severe neurologic deficit. The mRS ranges from 0-6 representing perfect health without symptoms to death. A score of 0 is no symptoms at all and a score of 1 is no significant disability. Able to carry out all usual duties and activities.

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Count of Participants

Participants

at 3 months

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000422 OG001419

Title

Denominators

Categories

Title	Measurements
	OG000186 OG001185

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Test of null hypothesis (equal proportions of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin and Saline treatment arms) versus alternative hypothesis (greater proportion of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin treatment arm).	Regression, Logistic	Adjustment is made for baseline NIHSS and Thrombolysis stratum.		The generalized linear model with log link function is tested at the one-sided alpha level of 0.025.	Risk Ratio (RR)	0.96			2-Sided	95	0.84	1.10			Adjusted risk ratio greater than 1 indicates greater risk of good outcome in the Albumin treatment group, while adjusted risk ratio less than 1 indicates greater risk of good outcome in the Saline treatment group.

Secondary

Number of Participants With a Composite Outcome of mRS 0-1 and/or NIHSS 0-1 and/or Decrease in NIHSS From Baseline by 10 or More Points

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Count of Participants

Participants

at 3 months

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Number of Participants With a NIHSS of 0-1 at 24 Hours

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Count of Participants

Participants

at 24 hours

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Number of Participants With a NIHSS 0-1 at 90 Days.

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Count of Participants

Participants

at 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

The Number of Participants With a Score on the mRS 0-1 at 90 Days.

The mRS ranges from 0-6 representing perfect health without symptoms to death. 0 = No symptoms at all. 1 = No significant disability. Able to carry out all usual duties and activities. 2 = Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 = Moderate disability. Requires some help, but able to walk unassisted. 4 = Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 = Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 = Dead.

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Count of Participants

Participants

at 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants

Secondary

The Number of Participants With a Score on the mRS of 0-2 at 90 Days.

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Count of Participants

Participants

at 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants

Secondary

Number of Participants With a Favorable Outcome Per Modified Rankin Scare (mRS)

Assessed as the final global disability level on the modified Rankin scale (mRS) at 90 days better than expectation (sliding dichotomy analysis) ) assessed in the intention to treat population.

mRS Scale:

0 - No symptoms.

- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Count of Participants

Participants

90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts

Secondary

Barthel Index (BI) 95-100

The Barthel Index (BI) is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables - feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. the highest total score for fully independent subjects equals 100. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence.

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Number

participants

at 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Number of Participants With an EuroQol (EQ-5D) Favorable Score < 0.78

The EQ-5D measures the subject's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems) within a particular EQ-5D dimension. The EQ-5D results can be converted to health utility scores.

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Count of Participants

Participants

at 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants

Secondary

Number of Participants With a Stroke Specific Quality of Life Scale (SSQOL) Score of >=3

Stroke, specific, health-related quality of life (SSQoL) is a self-reported survey that includes 12 domains and 49 items which are scored on a 5pt Likert response format with a lower score indicating worse function/lower ability on that item or domain. Domain scores were calculated as an unweighted average of item scores in that domain. Overall Total Score was calculated as an unweighted average of domain scores. Each Domain Score and the Overall Total Score all range from 1-5 with 1 being worst and 5 being the best. We have presented data here for the number of participants that have an unweighted average of domain scores of 3 or greater.

Posted

Count of Participants

Participants

at 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Trailmaking A

The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete ach part. Normally, the entire test (A and B) can be completed in 5-10 minutes.

Participants were excluded if the Tail Making Test was not assessed.

Posted

Median

Inter-Quartile Range

Minutes

at 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Trailmaking B

Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.

Posted

Median

Inter-Quartile Range

Minutes

at 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants

Secondary

Number of Participants With Neurological Deterioration Within 48 Hours

This is assessed as the number of participants with a neurological adverse event.

The safety sample consisted of the 830 subjects who received at least 20% of the indented dose of study-drug. In order to be considered for this analysis, subject must have had the event within the time frame or been followed for at least 48 hours.

Posted

Count of Participants

Participants

within 48 hours

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Neurological Death Within 7 Days

Posted

Number

participants

within 7 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Recurrent Ischemic Stroke Within 30 Days

Posted

Number

participants

within 30 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Atrial Fibrillation Within 48 Hours

Posted

Number

participants

within 48 hours

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Pulmonary Edema Within 48 Hours

Posted

Number

participants

within 48 hours

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Shortness of Breath Within 48 Hours

Posted

Number

participants

within 48 hours

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Symptomatic Intracerebral Hemorrhage (ICH) Within 24 Hours

Posted

Count of Participants

Participants

within 24 hours

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Asymptomatic ICH Within 24 Hours

Posted

Count of Participants

Participants

within 24 hours

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Death Within 30 Days

Posted

Number

participants

within 30 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Secondary

Death Within 90 Days

Posted

Number

participants

within 90 days

ID	Title	Description
OG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
OG001	Saline	Treatment with same volume of normal saline

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Statistical Information
FEVER	General disorders	EG0001 events1 affected422 at risk EG0012 events2 affected419 at risk
BACTEREMIA	Infections and infestations	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
SEPTICEMIA OR SEPTIC SHOCK	Infections and infestations	EG0003 events3 affected422 at risk EG0016 events5 affected419 at risk
OROLINGUAL ANGIOEDEMA	Immune system disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	EG0000 events0 affected422 at risk EG0012 events2 affected419 at risk
LOCALIZED PAIN	General disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
SYSTEMIC HEMORRHAGE	Blood and lymphatic system disorders	EG0002 events2 affected422 at risk EG0011 events1 affected419 at risk
FAILURE TO THRIVE	General disorders	EG0003 events3 affected422 at risk EG0011 events1 affected419 at risk
OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION	General disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
PNEUMONIA	Infections and infestations	EG00026 events22 affected422 at risk EG00113 events12 affected419 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	EG0008 events8 affected422 at risk EG0014 events4 affected419 at risk
PULMONARY EMBOLISM	Vascular disorders	EG0007 events7 affected422 at risk EG0015 events5 affected419 at risk
APNEA OR RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
RESPIRATORY INSUFFICIENCY	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
SHORTNESS OF BREATH	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
OTHER RESPIRATORY DISORDER OR COMPLICATION	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected422 at risk EG0015 events5 affected419 at risk
ANGINA PECTORIS (STABLE)	Cardiac disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION	Cardiac disorders	EG00015 events13 affected422 at risk EG0019 events9 affected419 at risk
CARDIAC ARREST	Cardiac disorders	EG0002 events2 affected422 at risk EG0016 events6 affected419 at risk
CARDIOGENIC SHOCK	Cardiac disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
"CONGESTIVE HEART FAILURE, PULMONARY EDEMA"	Cardiac disorders	EG00021 events21 affected422 at risk EG0017 events6 affected419 at risk
PERIPHERAL ARTERIAL OCCLUSION	Cardiac disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
VENTRICULAR FIBRILLATION OR TACHYCARDIA	Cardiac disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
ATRIAL FIBRILLATION/FLUTTER	Cardiac disorders	EG00011 events10 affected422 at risk EG0013 events3 affected419 at risk
BRADYCARDIA	Cardiac disorders	EG0005 events3 affected422 at risk EG0012 events2 affected419 at risk
"CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"	Cardiac disorders	EG0002 events2 affected422 at risk EG0010 events0 affected419 at risk
SUPRAVENTRICULAR ARRHYTHMIAS	Cardiac disorders	EG0000 events0 affected422 at risk EG0013 events3 affected419 at risk
DEEP VENOUS THROMBOSIS	Cardiac disorders	EG0001 events1 affected422 at risk EG0014 events4 affected419 at risk
ARTERIAL DISSECTION	Cardiac disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
ARTERIAL EMBOLUS	Cardiac disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
HYPERTENSION-NOT INTENDED	Vascular disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
HYPOTENSION-NOT INTENDED	Vascular disorders	EG0003 events3 affected422 at risk EG0015 events5 affected419 at risk
ACUTE CORONARY SYNDROME - UNSTABLE ANGINA	Cardiac disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN	Cardiac disorders	EG0003 events3 affected422 at risk EG0014 events4 affected419 at risk
TROPONIN LEAK	Cardiac disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
VALVULAR HEART DISEASE	Cardiac disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)	Vascular disorders	EG00010 events10 affected422 at risk EG0018 events8 affected419 at risk
OTHER CARDIAC ARRHYTHMIAS	Cardiac disorders	EG0001 events1 affected422 at risk EG0012 events2 affected419 at risk
OTHER CARDIOVASCULAR DISORDER OR COMPLICATION	Cardiac disorders	EG00010 events10 affected422 at risk EG00114 events13 affected419 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
GASTRIC OR DUODENAL ULCER	Gastrointestinal disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
NAUSEA/VOMITING	Gastrointestinal disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
GASTROINTESTINAL TRACT BLEEDING	Gastrointestinal disorders	EG0007 events7 affected422 at risk EG00112 events11 affected419 at risk
DYSPHAGIA	Gastrointestinal disorders	EG0002 events2 affected422 at risk EG0010 events0 affected419 at risk
PARALYTIC ILEUS/ BOWEL PSEUDO-OSTRUCTION	Gastrointestinal disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
BOWEL OSBTRUCTION	Gastrointestinal disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
OTHER DIGESTIVE DISORDER OR COMPLICATION	Gastrointestinal disorders	EG00010 events7 affected422 at risk EG00110 events9 affected419 at risk
HYPOGLYCEMIA	Metabolism and nutrition disorders	EG0002 events1 affected422 at risk EG0010 events0 affected419 at risk
HYPERGLYCEMIA	Metabolism and nutrition disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
HYPONATREMIA	Metabolism and nutrition disorders	EG0000 events0 affected422 at risk EG0013 events2 affected419 at risk
HYPOCALCEMIA	Metabolism and nutrition disorders	EG0002 events2 affected422 at risk EG0010 events0 affected419 at risk
DEHYDRATION	Metabolism and nutrition disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION	Metabolism and nutrition disorders	EG0003 events3 affected422 at risk EG0010 events0 affected419 at risk
NON-CEREBRAL HEMORRHAGE	Blood and lymphatic system disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
COAGULOPATHY	Blood and lymphatic system disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
ANEMIA	Blood and lymphatic system disorders	EG0002 events2 affected422 at risk EG0011 events1 affected419 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	EG0004 events4 affected422 at risk EG0010 events0 affected419 at risk
THROMBOTIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION	Nervous system disorders	EG00016 events16 affected422 at risk EG00119 events16 affected419 at risk
DEPRESSION OF CONSCIOUSNESS	Nervous system disorders	EG0002 events2 affected422 at risk EG0010 events0 affected419 at risk
BRAIN ABSCESS OR ENCEPHALITIS	Nervous system disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
MENINGITIS OR VENTRICULITIS	Nervous system disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
SYMPTOMATIC INTRACRANIAL HEMORRHAGE	Blood and lymphatic system disorders	EG00022 events22 affected422 at risk EG0018 events8 affected419 at risk
ASYMPTOMATIC INTRACRANIAL HEMORRHAGE	Blood and lymphatic system disorders	EG0002 events2 affected422 at risk EG0011 events1 affected419 at risk
TRANSIENT ISCHEMIC ATTACK	Nervous system disorders	EG0008 events6 affected422 at risk EG00110 events10 affected419 at risk
CEREBRAL INFARCTION	Nervous system disorders	EG0004 events4 affected422 at risk EG00114 events12 affected419 at risk
CEREBRAL EDEMA	Nervous system disorders	EG00018 events16 affected422 at risk EG00116 events16 affected419 at risk
SEIZURE	Nervous system disorders	EG00023 events18 affected422 at risk EG00118 events15 affected419 at risk
CONFUSION/ENCEPHALOPATHY/DELIRIUM	Nervous system disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
ANXIETY	Nervous system disorders	EG0003 events3 affected422 at risk EG0012 events2 affected419 at risk
HEADACHE	Nervous system disorders	EG0003 events3 affected422 at risk EG0016 events6 affected419 at risk
INCREASED INTRA-CRANIAL PRESSURE	Nervous system disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
PROGRESSION OF STROKE	Nervous system disorders	EG00017 events15 affected422 at risk EG00117 events16 affected419 at risk
SYNCOPE OR PRE-SYNCOPE	Vascular disorders	EG0008 events4 affected422 at risk EG0017 events7 affected419 at risk
OTHER NEUROLOGICAL DISORDER OR COMPLICATION	Nervous system disorders	EG00017 events16 affected422 at risk EG00113 events13 affected419 at risk
URINARY TRACT INFECTION	Infections and infestations	EG0008 events5 affected422 at risk EG0019 events9 affected419 at risk
HEMATURIA	Renal and urinary disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
RENAL INSUFFICIENCY	Renal and urinary disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
RENAL FAILURE	Renal and urinary disorders	EG0002 events2 affected422 at risk EG0013 events3 affected419 at risk
URINARY RETENTION	Renal and urinary disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
OTHER UROGENITAL DISORDER OR COMPLICATION	Renal and urinary disorders	EG0001 events1 affected422 at risk EG0017 events5 affected419 at risk
FRACTURE	Musculoskeletal and connective tissue disorders	EG0003 events3 affected422 at risk EG0014 events4 affected419 at risk
SURGICAL SITE INFECTION	Infections and infestations	EG0004 events4 affected422 at risk EG0010 events0 affected419 at risk
SURGICAL WOUND HEMATOMA	Injury, poisoning and procedural complications	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION	Injury, poisoning and procedural complications	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
DECUBITUS ULCERS/PRESSURE SORES	Skin and subcutaneous tissue disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
MALIGNANT NEOPLASM (EXCEPT SKIN)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0008 events8 affected422 at risk EG0018 events8 affected419 at risk
PSYCHIATRIC DEPRESSION	Psychiatric disorders	EG0003 events2 affected422 at risk EG0011 events1 affected419 at risk
FALL	Injury, poisoning and procedural complications	EG0004 events4 affected422 at risk EG0011 events1 affected419 at risk
"HEMATOMA, NOT OTHERWISE SPECIFIED"	Vascular disorders	EG0002 events2 affected422 at risk EG0011 events1 affected419 at risk
PSYCHIATRIC DISORDER	Psychiatric disorders	EG0004 events4 affected422 at risk EG0013 events1 affected419 at risk
CELLULITIS/NON-SURGICAL SKIN INFECTION	Infections and infestations	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
OTHER UNCLASSIFIED ADVERSE EVENT	General disorders	EG00012 events11 affected422 at risk EG0014 events4 affected419 at risk

Other Adverse Events

Term	Organ System	Statistical Information
FEVER	General disorders	EG00042 events38 affected422 at risk EG00135 events34 affected419 at risk
BACTEREMIA	Infections and infestations	EG0003 events3 affected422 at risk EG0012 events2 affected419 at risk
SEPTICEMIA OR SEPTIC SHOCK	Blood and lymphatic system disorders	EG0001 events1 affected422 at risk EG0013 events3 affected419 at risk
OROLINGUAL ANGIOEDEMA	Immune system disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
RASH	Skin and subcutaneous tissue disorders	EG00016 events16 affected422 at risk EG00116 events14 affected419 at risk
ITCHING	Skin and subcutaneous tissue disorders	EG0002 events2 affected422 at risk EG0015 events5 affected419 at risk
ALLERGIC REACTION TO STUDY DRUG	Immune system disorders	EG0003 events3 affected422 at risk EG0012 events2 affected419 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	EG0002 events2 affected422 at risk EG0013 events3 affected419 at risk
LOCALIZED PAIN	General disorders	EG00073 events54 affected422 at risk EG00178 events55 affected419 at risk
GENERALIZED PAIN	General disorders	EG00010 events9 affected422 at risk EG0019 events9 affected419 at risk
CRAMPING	Reproductive system and breast disorders	EG0007 events7 affected422 at risk EG0017 events6 affected419 at risk
SYSTEMIC HEMORRHAGE	Blood and lymphatic system disorders	EG00012 events11 affected422 at risk EG00111 events11 affected419 at risk
FATIGUE	General disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
DIZZINESS	Nervous system disorders	EG0006 events6 affected422 at risk EG0019 events9 affected419 at risk
OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION	General disorders	EG00018 events17 affected422 at risk EG00112 events12 affected419 at risk
PNEUMONIA	Infections and infestations	EG00033 events31 affected422 at risk EG00125 events23 affected419 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	EG0004 events3 affected422 at risk EG0013 events3 affected419 at risk
PULMONARY EMBOLISM	Vascular disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	EG0006 events6 affected422 at risk EG0018 events8 affected419 at risk
HYPOXEMIA	Respiratory, thoracic and mediastinal disorders	EG0005 events5 affected422 at risk EG0014 events4 affected419 at risk
HYPERCARBIA	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected422 at risk EG0011 events1 affected419 at risk
CRACKLES/RALES	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected422 at risk EG0016 events5 affected419 at risk
APNEA OR RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected422 at risk EG0010 events0 affected419 at risk
TACHYPNEA	Respiratory, thoracic and mediastinal disorders	EG0008 events8 affected422 at risk EG0017 events7 affected419 at risk
RESPIRATORY INSUFFICIENCY	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	EG00010 events9 affected422 at risk EG0019 events7 affected419 at risk
SHORTNESS OF BREATH	Respiratory, thoracic and mediastinal disorders	EG00013 events12 affected422 at risk EG0017 events7 affected419 at risk
UPPER REPIRATORY INFECTION	Infections and infestations	EG0009 events9 affected422 at risk EG00111 events11 affected419 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	EG0009 events8 affected422 at risk EG00111 events11 affected419 at risk
BRONCHITIS	Infections and infestations	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
OTHER RESPIRATORY DISORDER OR COMPLICATION	Respiratory, thoracic and mediastinal disorders	EG00045 events33 affected422 at risk EG00149 events36 affected419 at risk
ANGINA PECTORIS (STABLE)	Cardiac disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION	Cardiac disorders	EG0004 events4 affected422 at risk EG0010 events0 affected419 at risk
"CONGESTIVE HEART FAILURE, PULMONARY EDEMA"	Cardiac disorders	EG00045 events41 affected422 at risk EG00114 events14 affected419 at risk
VENTRICULAR FIBRILLATION OR TACHYCARDIA	Cardiac disorders	EG0002 events2 affected422 at risk EG0013 events3 affected419 at risk
ATRIAL FIBRILLATION/FLUTTER	Cardiac disorders	EG00042 events40 affected422 at risk EG00136 events35 affected419 at risk
BRADYCARDIA	Cardiac disorders	EG00027 events27 affected422 at risk EG00134 events32 affected419 at risk
TACHYCARDIA	Cardiac disorders	EG00014 events12 affected422 at risk EG00117 events17 affected419 at risk
"CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"	Cardiac disorders	EG0005 events4 affected422 at risk EG0011 events1 affected419 at risk
SUPRAVENTRICULAR ARRHYTHMIAS	Cardiac disorders	EG0008 events6 affected422 at risk EG0011 events1 affected419 at risk
DEEP VENOUS THROMBOSIS	Vascular disorders	EG0006 events6 affected422 at risk EG00112 events11 affected419 at risk
SUPERFICIAL VENOUS THROMBOSIS	Vascular disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
ARTERIAL DISSECTION	Injury, poisoning and procedural complications	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
ARTERIAL THROMBOSIS	Vascular disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
HYPERTENSION-NOT INTENDED	Vascular disorders	EG00042 events39 affected422 at risk EG00131 events29 affected419 at risk
HYPOTENSION-NOT INTENDED	Vascular disorders	EG00021 events19 affected422 at risk EG00136 events33 affected419 at risk
CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN	Cardiac disorders	EG0004 events4 affected422 at risk EG00115 events13 affected419 at risk
TROPONIN LEAK	Cardiac disorders	EG00053 events51 affected422 at risk EG00120 events20 affected419 at risk
VALVULAR HEART DISEASE	Cardiac disorders	EG0008 events6 affected422 at risk EG00116 events8 affected419 at risk
EKG ABNORMALITIES	Investigations	EG0008 events8 affected422 at risk EG0017 events7 affected419 at risk
PHLEBITIS	Infections and infestations	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)	Vascular disorders	EG0006 events6 affected422 at risk EG0015 events5 affected419 at risk
FLUID OVERLOAD ALONE	Metabolism and nutrition disorders	EG0004 events4 affected422 at risk EG0015 events5 affected419 at risk
OTHER CARDIAC ARRHYTHMIAS	Cardiac disorders	EG00015 events12 affected422 at risk EG00113 events10 affected419 at risk
OTHER CARDIOVASCULAR DISORDER OR COMPLICATION	Cardiac disorders	EG00034 events23 affected422 at risk EG00131 events23 affected419 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	EG00013 events13 affected422 at risk EG00115 events15 affected419 at risk
GASTRITIS/ ESOPHAGITIS/GERD	Gastrointestinal disorders	EG0008 events8 affected422 at risk EG00110 events7 affected419 at risk
GASTRIC OR DUODENAL ULCER	Gastrointestinal disorders	EG0000 events0 affected422 at risk EG0012 events2 affected419 at risk
NAUSEA/VOMITING	Gastrointestinal disorders	EG00081 events70 affected422 at risk EG00154 events48 affected419 at risk
GASTROINTESTINAL TRACT BLEEDING	Gastrointestinal disorders	EG0005 events5 affected422 at risk EG0018 events7 affected419 at risk
"HEPATITIS, JAUNDICE, OR LIVER FAILURE"	Hepatobiliary disorders	EG0000 events0 affected422 at risk EG0012 events2 affected419 at risk
DIARRHEA	Gastrointestinal disorders	EG00015 events15 affected422 at risk EG00110 events9 affected419 at risk
CONSTIPATION	Gastrointestinal disorders	EG00034 events30 affected422 at risk EG00151 events48 affected419 at risk
FECAL INCONTINENCE	Gastrointestinal disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
LIVER ENZYMES ELEVATION	Investigations	EG0006 events6 affected422 at risk EG0019 events9 affected419 at risk
DYSPHAGIA	Gastrointestinal disorders	EG0004 events4 affected422 at risk EG0012 events2 affected419 at risk
PARALYTIC ILEUS/ BOWEL PSEUDO-OSTRUCTION	Gastrointestinal disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
BOWEL OSBTRUCTION	Gastrointestinal disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
OTHER DIGESTIVE DISORDER OR COMPLICATION	Gastrointestinal disorders	EG00039 events33 affected422 at risk EG00149 events38 affected419 at risk
HYPOGLYCEMIA	Metabolism and nutrition disorders	EG0003 events3 affected422 at risk EG0016 events6 affected419 at risk
HYPERGLYCEMIA	Metabolism and nutrition disorders	EG00035 events34 affected422 at risk EG00131 events31 affected419 at risk
DIABETES INSIPIDUS	Metabolism and nutrition disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	EG0002 events2 affected422 at risk EG0016 events6 affected419 at risk
HYPONATREMIA	Metabolism and nutrition disorders	EG0005 events5 affected422 at risk EG0019 events9 affected419 at risk
HYPERNATREMIA	Metabolism and nutrition disorders	EG00011 events11 affected422 at risk EG0014 events4 affected419 at risk
HYPOKALEMIA	Metabolism and nutrition disorders	EG00099 events93 affected422 at risk EG00172 events66 affected419 at risk
HYPERKALEMIA	Metabolism and nutrition disorders	EG0006 events6 affected422 at risk EG0011 events1 affected419 at risk
HYPERLIPIDEMIA	Metabolism and nutrition disorders	EG0008 events8 affected422 at risk EG00121 events21 affected419 at risk
HYPOCALCEMIA	Metabolism and nutrition disorders	EG0006 events6 affected422 at risk EG00111 events11 affected419 at risk
HYPERCALCEMIA	Metabolism and nutrition disorders	EG0003 events3 affected422 at risk EG0010 events0 affected419 at risk
HYPOMAGNESEMIA	Metabolism and nutrition disorders	EG00019 events18 affected422 at risk EG00118 events18 affected419 at risk
DEHYDRATION	Metabolism and nutrition disorders	EG0005 events5 affected422 at risk EG0014 events4 affected419 at risk
ACID-BASE IMBALANCE	Metabolism and nutrition disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
HYPOCHLOREMIA	Metabolism and nutrition disorders	EG0000 events0 affected422 at risk EG0013 events3 affected419 at risk
HYPERCHLOREMIA	Metabolism and nutrition disorders	EG0002 events2 affected422 at risk EG0014 events4 affected419 at risk
OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION	Metabolism and nutrition disorders	EG00047 events36 affected422 at risk EG00163 events42 affected419 at risk
NON-CEREBRAL HEMORRHAGE	Blood and lymphatic system disorders	EG0002 events2 affected422 at risk EG0011 events1 affected419 at risk
ECCHYMOSIS	Skin and subcutaneous tissue disorders	EG00018 events16 affected422 at risk EG00129 events25 affected419 at risk
COAGULOPATHY	Blood and lymphatic system disorders	EG0002 events2 affected422 at risk EG0012 events2 affected419 at risk
ANEMIA	Blood and lymphatic system disorders	EG00043 events39 affected422 at risk EG00134 events29 affected419 at risk
POLYCYTEMIA	Blood and lymphatic system disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	EG0005 events5 affected422 at risk EG0014 events4 affected419 at risk
LEUKOPENIA	Blood and lymphatic system disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	EG00015 events15 affected422 at risk EG00114 events13 affected419 at risk
TROMBOCYTOSIS	Blood and lymphatic system disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
OTHER COAGULATION OR HEMATOLOGIC DISORDER OR COMPLICATION	Blood and lymphatic system disorders	EG0005 events5 affected422 at risk EG0019 events8 affected419 at risk
RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION	Blood and lymphatic system disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
DEPRESSION OF CONSCIOUSNESS	Nervous system disorders	EG00011 events10 affected422 at risk EG0017 events7 affected419 at risk
SYMPTOMATIC INTRACRANIAL HEMORRHAGE	Blood and lymphatic system disorders	EG0007 events7 affected422 at risk EG0016 events6 affected419 at risk
ASYMPTOMATIC INTRACRANIAL HEMORRHAGE	Blood and lymphatic system disorders	EG00048 events45 affected422 at risk EG00139 events35 affected419 at risk
CRANIAL NERVE INJURY	Injury, poisoning and procedural complications	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
TRANSIENT ISCHEMIC ATTACK	Vascular disorders	EG0003 events2 affected422 at risk EG0013 events3 affected419 at risk
CEREBRAL INFARCTION	Nervous system disorders	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
CEREBRAL EDEMA	Nervous system disorders	EG00010 events8 affected422 at risk EG00111 events10 affected419 at risk
SEIZURE	Nervous system disorders	EG00010 events10 affected422 at risk EG0019 events7 affected419 at risk
CONFUSION/ENCEPHALOPATHY/DELIRIUM	Psychiatric disorders	EG0005 events5 affected422 at risk EG0016 events6 affected419 at risk
ANXIETY	Psychiatric disorders	EG0009 events9 affected422 at risk EG00112 events12 affected419 at risk
HEADACHE	Nervous system disorders	EG00092 events81 affected422 at risk EG00184 events76 affected419 at risk
AGITATION	Nervous system disorders	EG00016 events15 affected422 at risk EG00124 events22 affected419 at risk
APHASIA	Psychiatric disorders	EG0002 events1 affected422 at risk EG0011 events1 affected419 at risk
INCREASED INTRA-CRANIAL PRESSURE	Nervous system disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
PROGRESSION OF STROKE	Nervous system disorders	EG00018 events18 affected422 at risk EG0019 events9 affected419 at risk
RETINAL VASCULAR ACCIDENT	Eye disorders	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
SYNCOPE OR PRE-SYNCOPE	Vascular disorders	EG0003 events3 affected422 at risk EG0013 events3 affected419 at risk
OTHER NEUROLOGICAL DISORDER OR COMPLICATION	Nervous system disorders	EG00038 events31 affected422 at risk EG00146 events39 affected419 at risk
URINARY TRACT INFECTION	Infections and infestations	EG00081 events73 affected422 at risk EG00183 events72 affected419 at risk
HEMATURIA	Renal and urinary disorders	EG00019 events19 affected422 at risk EG00118 events18 affected419 at risk
RENAL INSUFFICIENCY	Renal and urinary disorders	EG00012 events11 affected422 at risk EG0019 events8 affected419 at risk
RENAL FAILURE	Renal and urinary disorders	EG0002 events2 affected422 at risk EG0013 events3 affected419 at risk
UROGENITAL INCONTINENCE (WAS 410)	Renal and urinary disorders	EG0006 events6 affected422 at risk EG0015 events5 affected419 at risk
URINARY RETENTION	Renal and urinary disorders	EG00013 events11 affected422 at risk EG00113 events12 affected419 at risk
OTHER UROGENITAL DISORDER OR COMPLICATION	Renal and urinary disorders	EG00023 events21 affected422 at risk EG00131 events25 affected419 at risk
FRACTURE	Injury, poisoning and procedural complications	EG0004 events4 affected422 at risk EG0012 events2 affected419 at risk
INFILTRATION OF IV SITE	Injury, poisoning and procedural complications	EG0001 events1 affected422 at risk EG0014 events4 affected419 at risk
SURGICAL SITE INFECTION	Injury, poisoning and procedural complications	EG0002 events2 affected422 at risk EG0011 events1 affected419 at risk
SURGICAL WOUND HEMATOMA	Injury, poisoning and procedural complications	EG0002 events2 affected422 at risk EG0013 events3 affected419 at risk
OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION	Injury, poisoning and procedural complications	EG0004 events4 affected422 at risk EG0015 events5 affected419 at risk
DECUBITUS ULCERS/PRESSURE SORES	Skin and subcutaneous tissue disorders	EG0003 events3 affected422 at risk EG0019 events8 affected419 at risk
BLISTER	Injury, poisoning and procedural complications	EG0000 events0 affected422 at risk EG0012 events2 affected419 at risk
MALIGNANT NEOPLASM (EXCEPT SKIN)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
MALIGNANT NEOPLASM (SKIN)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected422 at risk EG0010 events0 affected419 at risk
ACCIDENTAL TRAUMA	Injury, poisoning and procedural complications	EG0000 events0 affected422 at risk EG0011 events1 affected419 at risk
PSYCHIATRIC DEPRESSION	Psychiatric disorders	EG00034 events32 affected422 at risk EG00135 events35 affected419 at risk
FALL	Injury, poisoning and procedural complications	EG00015 events14 affected422 at risk EG00115 events13 affected419 at risk
PERIPHERAL EDEMA	General disorders	EG00019 events16 affected422 at risk EG00123 events16 affected419 at risk
OTHER ENZYME/S ELEVATION	Investigations	EG0003 events3 affected422 at risk EG0013 events2 affected419 at risk
INSOMNIA	Psychiatric disorders	EG00019 events19 affected422 at risk EG00130 events29 affected419 at risk
"HEMATOMA, NOT OTHERWISE SPECIFIED"	Vascular disorders	EG00012 events12 affected422 at risk EG00110 events8 affected419 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	EG0005 events4 affected422 at risk EG0016 events6 affected419 at risk
PSYCHIATRIC DISORDER	Psychiatric disorders	EG0002 events2 affected422 at risk EG0015 events5 affected419 at risk
CELLULITIS/NON-SURGICAL SKIN INFECTION	Infections and infestations	EG00016 events14 affected422 at risk EG00114 events11 affected419 at risk
OTHER UNCLASSIFIED ADVERSE EVENT	General disorders	EG00049 events40 affected422 at risk EG00154 events40 affected419 at risk

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

ID	Term
D000418	Albumins
D012965	Sodium Chloride

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Title	Description
BG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg
BG001	Saline	Treatment with same volume of normal saline
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Albumin	Treatment with 25% Albumin, 2.0 g/kg			212	422	352	422
EG001	Saline	Treatment with same volume of normal saline			178	419	341	419