Trial Outcomes & Findings for Albumin in Acute Ischemic Stroke Trial (NCT NCT00235495)
NCT ID: NCT00235495
Last Updated: 2019-12-17
Results Overview
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.
TERMINATED
PHASE3
841 participants
at 3 months
2019-12-17
Participant Flow
Participant milestones
| Measure |
Albumin
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
Treatment with same volume of normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
422
|
419
|
|
Overall Study
COMPLETED
|
354
|
351
|
|
Overall Study
NOT COMPLETED
|
68
|
68
|
Reasons for withdrawal
| Measure |
Albumin
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
Treatment with same volume of normal saline
|
|---|---|---|
|
Overall Study
Death
|
52
|
42
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
11
|
13
|
|
Overall Study
Visit/assessmen outside window/missing
|
0
|
10
|
Baseline Characteristics
Albumin in Acute Ischemic Stroke Trial
Baseline characteristics by cohort
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
Total
n=841 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
202 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
390 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
219 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Age, Continuous
|
63.42 years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
64.84 years
STANDARD_DEVIATION 12.88 • n=7 Participants
|
64.13 years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
455 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
379 Participants
n=5 Participants
|
372 Participants
n=7 Participants
|
751 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native/First Nations People
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
69 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
314 Participants
n=5 Participants
|
305 Participants
n=7 Participants
|
619 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple, Other, or Unknown
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Oxfordshire Community Stroke Project Classification
Total Anterior Circulation Syndrome
|
102 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Oxfordshire Community Stroke Project Classification
Partial Anterior Circulation Syndrome
|
232 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
467 Participants
n=5 Participants
|
|
Oxfordshire Community Stroke Project Classification
Posterior Circulation Syndrome
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Oxfordshire Community Stroke Project Classification
Lacunar Stroke
|
53 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Baseline National Institutes of Health Stroke Scale (NIHSS) Score
|
11 units on a scale
n=5 Participants
|
11 units on a scale
n=7 Participants
|
11 units on a scale
n=5 Participants
|
|
Baseline ASPECTS
Baseline ASPECTS >7
|
325 Participants
n=5 Participants
|
327 Participants
n=7 Participants
|
652 Participants
n=5 Participants
|
|
Baseline ASPECTS
Baseline ASPECTS <= 7
|
93 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Baseline ASPECTS
Missing
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 3 monthsPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
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.
|
186 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: at 3 monthsPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
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
|
227 Participants
|
241 Participants
|
SECONDARY outcome
Timeframe: at 24 hoursPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Number of Participants With a NIHSS of 0-1 at 24 Hours
|
65 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Number of Participants With a NIHSS 0-1 at 90 Days.
|
65 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
The Number of Participants With a Score on the mRS 0-1 at 90 Days.
|
155 Participants
|
145 Participants
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
The Number of Participants With a Score on the mRS of 0-2 at 90 Days.
|
227 Participants
|
221 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Number of Participants With a Favorable Outcome Per Modified Rankin Scare (mRS)
|
142 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Barthel Index (BI) 95-100
BI 95-100
|
227 participants
|
231 participants
|
|
Barthel Index (BI) 95-100
Otherwise
|
195 participants
|
188 participants
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Number of Participants With an EuroQol (EQ-5D) Favorable Score < 0.78
|
155 Participants
|
152 Participants
|
SECONDARY outcome
Timeframe: at 90 daysStroke, 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.
Outcome measures
| Measure |
Albumin
n=422 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Number of Participants With a Stroke Specific Quality of Life Scale (SSQOL) Score of >=3
|
258 Participants
|
268 Participants
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Participants were excluded if the Tail Making Test was not assessed.
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.
Outcome measures
| Measure |
Albumin
n=269 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=272 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Trailmaking A
|
55 Minutes
Interval 39.0 to 105.0
|
56 Minutes
Interval 39.0 to 90.0
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Intent to Treat population - All subjects randomized into the study are included and analyzed based on the treatment arm to which they were randomized.
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.
Outcome measures
| Measure |
Albumin
n=215 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=210 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Trailmaking B
|
111 Minutes
Interval 78.0 to 173.0
|
110 Minutes
Interval 82.0 to 180.0
|
SECONDARY outcome
Timeframe: within 48 hoursPopulation: 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.
This is assessed as the number of participants with a neurological adverse event.
Outcome measures
| Measure |
Albumin
n=411 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=412 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Number of Participants With Neurological Deterioration Within 48 Hours
|
47 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: within 7 daysPopulation: 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 7 days.
Outcome measures
| Measure |
Albumin
n=404 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=407 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Neurological Death Within 7 Days
|
13 participants
|
13 participants
|
SECONDARY outcome
Timeframe: within 30 daysPopulation: 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 30 days.
Outcome measures
| Measure |
Albumin
n=373 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=370 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Recurrent Ischemic Stroke Within 30 Days
|
7 participants
|
6 participants
|
SECONDARY outcome
Timeframe: within 48 hoursPopulation: 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.
Outcome measures
| Measure |
Albumin
n=410 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=412 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Atrial Fibrillation Within 48 Hours
|
32 participants
|
19 participants
|
SECONDARY outcome
Timeframe: within 48 hoursPopulation: 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.
Outcome measures
| Measure |
Albumin
n=412 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=412 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Pulmonary Edema Within 48 Hours
|
54 participants
|
5 participants
|
SECONDARY outcome
Timeframe: within 48 hoursPopulation: 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.
Outcome measures
| Measure |
Albumin
n=410 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=412 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Shortness of Breath Within 48 Hours
|
18 participants
|
7 participants
|
SECONDARY outcome
Timeframe: within 24 hoursPopulation: 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 24 hours.
Outcome measures
| Measure |
Albumin
n=415 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=414 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Symptomatic Intracerebral Hemorrhage (ICH) Within 24 Hours
|
17 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: within 24 hoursPopulation: 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 24 hours.
Outcome measures
| Measure |
Albumin
n=415 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=414 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Asymptomatic ICH Within 24 Hours
|
27 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: within 30 daysPopulation: 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 30 days.
Outcome measures
| Measure |
Albumin
n=409 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=406 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Death Within 30 Days
|
39 participants
|
37 participants
|
SECONDARY outcome
Timeframe: within 90 daysPopulation: 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 90 days.
Outcome measures
| Measure |
Albumin
n=378 Participants
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=369 Participants
Treatment with same volume of normal saline
|
|---|---|---|
|
Death Within 90 Days
|
46 participants
|
41 participants
|
Adverse Events
Albumin
Saline
Serious adverse events
| Measure |
Albumin
n=422 participants at risk
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 participants at risk
Treatment with same volume of normal saline
|
|---|---|---|
|
General disorders
FEVER
|
0.24%
1/422 • Number of events 1
|
0.48%
2/419 • Number of events 2
|
|
Infections and infestations
BACTEREMIA
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Infections and infestations
SEPTICEMIA OR SEPTIC SHOCK
|
0.71%
3/422 • Number of events 3
|
1.2%
5/419 • Number of events 6
|
|
Immune system disorders
OROLINGUAL ANGIOEDEMA
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/422
|
0.48%
2/419 • Number of events 2
|
|
General disorders
LOCALIZED PAIN
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Blood and lymphatic system disorders
SYSTEMIC HEMORRHAGE
|
0.47%
2/422 • Number of events 2
|
0.24%
1/419 • Number of events 1
|
|
General disorders
FAILURE TO THRIVE
|
0.71%
3/422 • Number of events 3
|
0.24%
1/419 • Number of events 1
|
|
General disorders
OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
5.2%
22/422 • Number of events 26
|
2.9%
12/419 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE
|
1.9%
8/422 • Number of events 8
|
0.95%
4/419 • Number of events 4
|
|
Vascular disorders
PULMONARY EMBOLISM
|
1.7%
7/422 • Number of events 7
|
1.2%
5/419 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
APNEA OR RESPIRATORY ARREST
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INSUFFICIENCY
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
OTHER RESPIRATORY DISORDER OR COMPLICATION
|
0.71%
3/422 • Number of events 3
|
1.2%
5/419 • Number of events 5
|
|
Cardiac disorders
ANGINA PECTORIS (STABLE)
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION
|
3.1%
13/422 • Number of events 15
|
2.1%
9/419 • Number of events 9
|
|
Cardiac disorders
CARDIAC ARREST
|
0.47%
2/422 • Number of events 2
|
1.4%
6/419 • Number of events 6
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Cardiac disorders
"CONGESTIVE HEART FAILURE, PULMONARY EDEMA"
|
5.0%
21/422 • Number of events 21
|
1.4%
6/419 • Number of events 7
|
|
Cardiac disorders
PERIPHERAL ARTERIAL OCCLUSION
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION OR TACHYCARDIA
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Cardiac disorders
ATRIAL FIBRILLATION/FLUTTER
|
2.4%
10/422 • Number of events 11
|
0.72%
3/419 • Number of events 3
|
|
Cardiac disorders
BRADYCARDIA
|
0.71%
3/422 • Number of events 5
|
0.48%
2/419 • Number of events 2
|
|
Cardiac disorders
"CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"
|
0.47%
2/422 • Number of events 2
|
0.00%
0/419
|
|
Cardiac disorders
SUPRAVENTRICULAR ARRHYTHMIAS
|
0.00%
0/422
|
0.72%
3/419 • Number of events 3
|
|
Cardiac disorders
DEEP VENOUS THROMBOSIS
|
0.24%
1/422 • Number of events 1
|
0.95%
4/419 • Number of events 4
|
|
Cardiac disorders
ARTERIAL DISSECTION
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Cardiac disorders
ARTERIAL EMBOLUS
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Vascular disorders
HYPERTENSION-NOT INTENDED
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Vascular disorders
HYPOTENSION-NOT INTENDED
|
0.71%
3/422 • Number of events 3
|
1.2%
5/419 • Number of events 5
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME - UNSTABLE ANGINA
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Cardiac disorders
CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN
|
0.71%
3/422 • Number of events 3
|
0.95%
4/419 • Number of events 4
|
|
Cardiac disorders
TROPONIN LEAK
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Cardiac disorders
VALVULAR HEART DISEASE
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Vascular disorders
PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)
|
2.4%
10/422 • Number of events 10
|
1.9%
8/419 • Number of events 8
|
|
Cardiac disorders
OTHER CARDIAC ARRHYTHMIAS
|
0.24%
1/422 • Number of events 1
|
0.48%
2/419 • Number of events 2
|
|
Cardiac disorders
OTHER CARDIOVASCULAR DISORDER OR COMPLICATION
|
2.4%
10/422 • Number of events 10
|
3.1%
13/419 • Number of events 14
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Gastrointestinal disorders
GASTRIC OR DUODENAL ULCER
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Gastrointestinal disorders
NAUSEA/VOMITING
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Gastrointestinal disorders
GASTROINTESTINAL TRACT BLEEDING
|
1.7%
7/422 • Number of events 7
|
2.6%
11/419 • Number of events 12
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.47%
2/422 • Number of events 2
|
0.00%
0/419
|
|
Gastrointestinal disorders
PARALYTIC ILEUS/ BOWEL PSEUDO-OSTRUCTION
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Gastrointestinal disorders
BOWEL OSBTRUCTION
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Gastrointestinal disorders
OTHER DIGESTIVE DISORDER OR COMPLICATION
|
1.7%
7/422 • Number of events 10
|
2.1%
9/419 • Number of events 10
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.24%
1/422 • Number of events 2
|
0.00%
0/419
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
0.00%
0/422
|
0.48%
2/419 • Number of events 3
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.47%
2/422 • Number of events 2
|
0.00%
0/419
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Metabolism and nutrition disorders
OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION
|
0.71%
3/422 • Number of events 3
|
0.00%
0/419
|
|
Blood and lymphatic system disorders
NON-CEREBRAL HEMORRHAGE
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.47%
2/422 • Number of events 2
|
0.24%
1/419 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.95%
4/422 • Number of events 4
|
0.00%
0/419
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Nervous system disorders
RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION
|
3.8%
16/422 • Number of events 16
|
3.8%
16/419 • Number of events 19
|
|
Nervous system disorders
DEPRESSION OF CONSCIOUSNESS
|
0.47%
2/422 • Number of events 2
|
0.00%
0/419
|
|
Nervous system disorders
BRAIN ABSCESS OR ENCEPHALITIS
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Nervous system disorders
MENINGITIS OR VENTRICULITIS
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Blood and lymphatic system disorders
SYMPTOMATIC INTRACRANIAL HEMORRHAGE
|
5.2%
22/422 • Number of events 22
|
1.9%
8/419 • Number of events 8
|
|
Blood and lymphatic system disorders
ASYMPTOMATIC INTRACRANIAL HEMORRHAGE
|
0.47%
2/422 • Number of events 2
|
0.24%
1/419 • Number of events 1
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACK
|
1.4%
6/422 • Number of events 8
|
2.4%
10/419 • Number of events 10
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.95%
4/422 • Number of events 4
|
2.9%
12/419 • Number of events 14
|
|
Nervous system disorders
CEREBRAL EDEMA
|
3.8%
16/422 • Number of events 18
|
3.8%
16/419 • Number of events 16
|
|
Nervous system disorders
SEIZURE
|
4.3%
18/422 • Number of events 23
|
3.6%
15/419 • Number of events 18
|
|
Nervous system disorders
CONFUSION/ENCEPHALOPATHY/DELIRIUM
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Nervous system disorders
ANXIETY
|
0.71%
3/422 • Number of events 3
|
0.48%
2/419 • Number of events 2
|
|
Nervous system disorders
HEADACHE
|
0.71%
3/422 • Number of events 3
|
1.4%
6/419 • Number of events 6
|
|
Nervous system disorders
INCREASED INTRA-CRANIAL PRESSURE
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Nervous system disorders
PROGRESSION OF STROKE
|
3.6%
15/422 • Number of events 17
|
3.8%
16/419 • Number of events 17
|
|
Vascular disorders
SYNCOPE OR PRE-SYNCOPE
|
0.95%
4/422 • Number of events 8
|
1.7%
7/419 • Number of events 7
|
|
Nervous system disorders
OTHER NEUROLOGICAL DISORDER OR COMPLICATION
|
3.8%
16/422 • Number of events 17
|
3.1%
13/419 • Number of events 13
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.2%
5/422 • Number of events 8
|
2.1%
9/419 • Number of events 9
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Renal and urinary disorders
RENAL INSUFFICIENCY
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.47%
2/422 • Number of events 2
|
0.72%
3/419 • Number of events 3
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Renal and urinary disorders
OTHER UROGENITAL DISORDER OR COMPLICATION
|
0.24%
1/422 • Number of events 1
|
1.2%
5/419 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
0.71%
3/422 • Number of events 3
|
0.95%
4/419 • Number of events 4
|
|
Infections and infestations
SURGICAL SITE INFECTION
|
0.95%
4/422 • Number of events 4
|
0.00%
0/419
|
|
Injury, poisoning and procedural complications
SURGICAL WOUND HEMATOMA
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Injury, poisoning and procedural complications
OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCERS/PRESSURE SORES
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM (EXCEPT SKIN)
|
1.9%
8/422 • Number of events 8
|
1.9%
8/419 • Number of events 8
|
|
Psychiatric disorders
PSYCHIATRIC DEPRESSION
|
0.47%
2/422 • Number of events 3
|
0.24%
1/419 • Number of events 1
|
|
Injury, poisoning and procedural complications
FALL
|
0.95%
4/422 • Number of events 4
|
0.24%
1/419 • Number of events 1
|
|
Vascular disorders
"HEMATOMA, NOT OTHERWISE SPECIFIED"
|
0.47%
2/422 • Number of events 2
|
0.24%
1/419 • Number of events 1
|
|
Psychiatric disorders
PSYCHIATRIC DISORDER
|
0.95%
4/422 • Number of events 4
|
0.24%
1/419 • Number of events 3
|
|
Infections and infestations
CELLULITIS/NON-SURGICAL SKIN INFECTION
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
General disorders
OTHER UNCLASSIFIED ADVERSE EVENT
|
2.6%
11/422 • Number of events 12
|
0.95%
4/419 • Number of events 4
|
Other adverse events
| Measure |
Albumin
n=422 participants at risk
Treatment with 25% Albumin, 2.0 g/kg
|
Saline
n=419 participants at risk
Treatment with same volume of normal saline
|
|---|---|---|
|
General disorders
FEVER
|
9.0%
38/422 • Number of events 42
|
8.1%
34/419 • Number of events 35
|
|
Infections and infestations
BACTEREMIA
|
0.71%
3/422 • Number of events 3
|
0.48%
2/419 • Number of events 2
|
|
Blood and lymphatic system disorders
SEPTICEMIA OR SEPTIC SHOCK
|
0.24%
1/422 • Number of events 1
|
0.72%
3/419 • Number of events 3
|
|
Immune system disorders
OROLINGUAL ANGIOEDEMA
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH
|
3.8%
16/422 • Number of events 16
|
3.3%
14/419 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
ITCHING
|
0.47%
2/422 • Number of events 2
|
1.2%
5/419 • Number of events 5
|
|
Immune system disorders
ALLERGIC REACTION TO STUDY DRUG
|
0.71%
3/422 • Number of events 3
|
0.48%
2/419 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.47%
2/422 • Number of events 2
|
0.72%
3/419 • Number of events 3
|
|
General disorders
LOCALIZED PAIN
|
12.8%
54/422 • Number of events 73
|
13.1%
55/419 • Number of events 78
|
|
General disorders
GENERALIZED PAIN
|
2.1%
9/422 • Number of events 10
|
2.1%
9/419 • Number of events 9
|
|
Reproductive system and breast disorders
CRAMPING
|
1.7%
7/422 • Number of events 7
|
1.4%
6/419 • Number of events 7
|
|
Blood and lymphatic system disorders
SYSTEMIC HEMORRHAGE
|
2.6%
11/422 • Number of events 12
|
2.6%
11/419 • Number of events 11
|
|
General disorders
FATIGUE
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Nervous system disorders
DIZZINESS
|
1.4%
6/422 • Number of events 6
|
2.1%
9/419 • Number of events 9
|
|
General disorders
OTHER SYSTEMIC ADVERSE EVENT OR COMPLICATION
|
4.0%
17/422 • Number of events 18
|
2.9%
12/419 • Number of events 12
|
|
Infections and infestations
PNEUMONIA
|
7.3%
31/422 • Number of events 33
|
5.5%
23/419 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) OR RESPIRATORY FAILURE
|
0.71%
3/422 • Number of events 4
|
0.72%
3/419 • Number of events 3
|
|
Vascular disorders
PULMONARY EMBOLISM
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
1.4%
6/422 • Number of events 6
|
1.9%
8/419 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXEMIA
|
1.2%
5/422 • Number of events 5
|
0.95%
4/419 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
HYPERCARBIA
|
0.24%
1/422 • Number of events 1
|
0.24%
1/419 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
CRACKLES/RALES
|
0.71%
3/422 • Number of events 3
|
1.2%
5/419 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
APNEA OR RESPIRATORY ARREST
|
0.47%
2/422 • Number of events 2
|
0.00%
0/419
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNEA
|
1.9%
8/422 • Number of events 8
|
1.7%
7/419 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY INSUFFICIENCY
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.1%
9/422 • Number of events 10
|
1.7%
7/419 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
2.8%
12/422 • Number of events 13
|
1.7%
7/419 • Number of events 7
|
|
Infections and infestations
UPPER REPIRATORY INFECTION
|
2.1%
9/422 • Number of events 9
|
2.6%
11/419 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.9%
8/422 • Number of events 9
|
2.6%
11/419 • Number of events 11
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
OTHER RESPIRATORY DISORDER OR COMPLICATION
|
7.8%
33/422 • Number of events 45
|
8.6%
36/419 • Number of events 49
|
|
Cardiac disorders
ANGINA PECTORIS (STABLE)
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME - MYOCARDIAL INFARCTION
|
0.95%
4/422 • Number of events 4
|
0.00%
0/419
|
|
Cardiac disorders
"CONGESTIVE HEART FAILURE, PULMONARY EDEMA"
|
9.7%
41/422 • Number of events 45
|
3.3%
14/419 • Number of events 14
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION OR TACHYCARDIA
|
0.47%
2/422 • Number of events 2
|
0.72%
3/419 • Number of events 3
|
|
Cardiac disorders
ATRIAL FIBRILLATION/FLUTTER
|
9.5%
40/422 • Number of events 42
|
8.4%
35/419 • Number of events 36
|
|
Cardiac disorders
BRADYCARDIA
|
6.4%
27/422 • Number of events 27
|
7.6%
32/419 • Number of events 34
|
|
Cardiac disorders
TACHYCARDIA
|
2.8%
12/422 • Number of events 14
|
4.1%
17/419 • Number of events 17
|
|
Cardiac disorders
"CONDUCTION BLOCKS (ATRIO-VENTRICULAR BLOCKS, BUNDLE-BRANCH BLOCKS)"
|
0.95%
4/422 • Number of events 5
|
0.24%
1/419 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR ARRHYTHMIAS
|
1.4%
6/422 • Number of events 8
|
0.24%
1/419 • Number of events 1
|
|
Vascular disorders
DEEP VENOUS THROMBOSIS
|
1.4%
6/422 • Number of events 6
|
2.6%
11/419 • Number of events 12
|
|
Vascular disorders
SUPERFICIAL VENOUS THROMBOSIS
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Injury, poisoning and procedural complications
ARTERIAL DISSECTION
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Vascular disorders
ARTERIAL THROMBOSIS
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Vascular disorders
HYPERTENSION-NOT INTENDED
|
9.2%
39/422 • Number of events 42
|
6.9%
29/419 • Number of events 31
|
|
Vascular disorders
HYPOTENSION-NOT INTENDED
|
4.5%
19/422 • Number of events 21
|
7.9%
33/419 • Number of events 36
|
|
Cardiac disorders
CHEST PAIN (INCLUDING ATYPICAL) WITHOUT MENTION OF CARDIAC ORIGEN
|
0.95%
4/422 • Number of events 4
|
3.1%
13/419 • Number of events 15
|
|
Cardiac disorders
TROPONIN LEAK
|
12.1%
51/422 • Number of events 53
|
4.8%
20/419 • Number of events 20
|
|
Cardiac disorders
VALVULAR HEART DISEASE
|
1.4%
6/422 • Number of events 8
|
1.9%
8/419 • Number of events 16
|
|
Investigations
EKG ABNORMALITIES
|
1.9%
8/422 • Number of events 8
|
1.7%
7/419 • Number of events 7
|
|
Infections and infestations
PHLEBITIS
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Vascular disorders
PRE-CEREBRAL OR CEREBRAL VASCULAR DISEASE (INCLUDING STENOSIS OR OCCLUSION)
|
1.4%
6/422 • Number of events 6
|
1.2%
5/419 • Number of events 5
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD ALONE
|
0.95%
4/422 • Number of events 4
|
1.2%
5/419 • Number of events 5
|
|
Cardiac disorders
OTHER CARDIAC ARRHYTHMIAS
|
2.8%
12/422 • Number of events 15
|
2.4%
10/419 • Number of events 13
|
|
Cardiac disorders
OTHER CARDIOVASCULAR DISORDER OR COMPLICATION
|
5.5%
23/422 • Number of events 34
|
5.5%
23/419 • Number of events 31
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.1%
13/422 • Number of events 13
|
3.6%
15/419 • Number of events 15
|
|
Gastrointestinal disorders
GASTRITIS/ ESOPHAGITIS/GERD
|
1.9%
8/422 • Number of events 8
|
1.7%
7/419 • Number of events 10
|
|
Gastrointestinal disorders
GASTRIC OR DUODENAL ULCER
|
0.00%
0/422
|
0.48%
2/419 • Number of events 2
|
|
Gastrointestinal disorders
NAUSEA/VOMITING
|
16.6%
70/422 • Number of events 81
|
11.5%
48/419 • Number of events 54
|
|
Gastrointestinal disorders
GASTROINTESTINAL TRACT BLEEDING
|
1.2%
5/422 • Number of events 5
|
1.7%
7/419 • Number of events 8
|
|
Hepatobiliary disorders
"HEPATITIS, JAUNDICE, OR LIVER FAILURE"
|
0.00%
0/422
|
0.48%
2/419 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHEA
|
3.6%
15/422 • Number of events 15
|
2.1%
9/419 • Number of events 10
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.1%
30/422 • Number of events 34
|
11.5%
48/419 • Number of events 51
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Investigations
LIVER ENZYMES ELEVATION
|
1.4%
6/422 • Number of events 6
|
2.1%
9/419 • Number of events 9
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.95%
4/422 • Number of events 4
|
0.48%
2/419 • Number of events 2
|
|
Gastrointestinal disorders
PARALYTIC ILEUS/ BOWEL PSEUDO-OSTRUCTION
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Gastrointestinal disorders
BOWEL OSBTRUCTION
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Gastrointestinal disorders
OTHER DIGESTIVE DISORDER OR COMPLICATION
|
7.8%
33/422 • Number of events 39
|
9.1%
38/419 • Number of events 49
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.71%
3/422 • Number of events 3
|
1.4%
6/419 • Number of events 6
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
8.1%
34/422 • Number of events 35
|
7.4%
31/419 • Number of events 31
|
|
Metabolism and nutrition disorders
DIABETES INSIPIDUS
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.47%
2/422 • Number of events 2
|
1.4%
6/419 • Number of events 6
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
1.2%
5/422 • Number of events 5
|
2.1%
9/419 • Number of events 9
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
2.6%
11/422 • Number of events 11
|
0.95%
4/419 • Number of events 4
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
22.0%
93/422 • Number of events 99
|
15.8%
66/419 • Number of events 72
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
1.4%
6/422 • Number of events 6
|
0.24%
1/419 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERLIPIDEMIA
|
1.9%
8/422 • Number of events 8
|
5.0%
21/419 • Number of events 21
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
1.4%
6/422 • Number of events 6
|
2.6%
11/419 • Number of events 11
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.71%
3/422 • Number of events 3
|
0.00%
0/419
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
4.3%
18/422 • Number of events 19
|
4.3%
18/419 • Number of events 18
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.2%
5/422 • Number of events 5
|
0.95%
4/419 • Number of events 4
|
|
Metabolism and nutrition disorders
ACID-BASE IMBALANCE
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Metabolism and nutrition disorders
HYPOCHLOREMIA
|
0.00%
0/422
|
0.72%
3/419 • Number of events 3
|
|
Metabolism and nutrition disorders
HYPERCHLOREMIA
|
0.47%
2/422 • Number of events 2
|
0.95%
4/419 • Number of events 4
|
|
Metabolism and nutrition disorders
OTHER ENDOCRINE OR METABOLIC DISORDER OR COMPLICATION
|
8.5%
36/422 • Number of events 47
|
10.0%
42/419 • Number of events 63
|
|
Blood and lymphatic system disorders
NON-CEREBRAL HEMORRHAGE
|
0.47%
2/422 • Number of events 2
|
0.24%
1/419 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
3.8%
16/422 • Number of events 18
|
6.0%
25/419 • Number of events 29
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.47%
2/422 • Number of events 2
|
0.48%
2/419 • Number of events 2
|
|
Blood and lymphatic system disorders
ANEMIA
|
9.2%
39/422 • Number of events 43
|
6.9%
29/419 • Number of events 34
|
|
Blood and lymphatic system disorders
POLYCYTEMIA
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.2%
5/422 • Number of events 5
|
0.95%
4/419 • Number of events 4
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
3.6%
15/422 • Number of events 15
|
3.1%
13/419 • Number of events 14
|
|
Blood and lymphatic system disorders
TROMBOCYTOSIS
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Blood and lymphatic system disorders
OTHER COAGULATION OR HEMATOLOGIC DISORDER OR COMPLICATION
|
1.2%
5/422 • Number of events 5
|
1.9%
8/419 • Number of events 9
|
|
Blood and lymphatic system disorders
RECURRENT STROKE NOT SPECIFIED AS HEMORRHAGE OR INFARCTION
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Nervous system disorders
DEPRESSION OF CONSCIOUSNESS
|
2.4%
10/422 • Number of events 11
|
1.7%
7/419 • Number of events 7
|
|
Blood and lymphatic system disorders
SYMPTOMATIC INTRACRANIAL HEMORRHAGE
|
1.7%
7/422 • Number of events 7
|
1.4%
6/419 • Number of events 6
|
|
Blood and lymphatic system disorders
ASYMPTOMATIC INTRACRANIAL HEMORRHAGE
|
10.7%
45/422 • Number of events 48
|
8.4%
35/419 • Number of events 39
|
|
Injury, poisoning and procedural complications
CRANIAL NERVE INJURY
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Vascular disorders
TRANSIENT ISCHEMIC ATTACK
|
0.47%
2/422 • Number of events 3
|
0.72%
3/419 • Number of events 3
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Nervous system disorders
CEREBRAL EDEMA
|
1.9%
8/422 • Number of events 10
|
2.4%
10/419 • Number of events 11
|
|
Nervous system disorders
SEIZURE
|
2.4%
10/422 • Number of events 10
|
1.7%
7/419 • Number of events 9
|
|
Psychiatric disorders
CONFUSION/ENCEPHALOPATHY/DELIRIUM
|
1.2%
5/422 • Number of events 5
|
1.4%
6/419 • Number of events 6
|
|
Psychiatric disorders
ANXIETY
|
2.1%
9/422 • Number of events 9
|
2.9%
12/419 • Number of events 12
|
|
Nervous system disorders
HEADACHE
|
19.2%
81/422 • Number of events 92
|
18.1%
76/419 • Number of events 84
|
|
Nervous system disorders
AGITATION
|
3.6%
15/422 • Number of events 16
|
5.3%
22/419 • Number of events 24
|
|
Psychiatric disorders
APHASIA
|
0.24%
1/422 • Number of events 2
|
0.24%
1/419 • Number of events 1
|
|
Nervous system disorders
INCREASED INTRA-CRANIAL PRESSURE
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Nervous system disorders
PROGRESSION OF STROKE
|
4.3%
18/422 • Number of events 18
|
2.1%
9/419 • Number of events 9
|
|
Eye disorders
RETINAL VASCULAR ACCIDENT
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Vascular disorders
SYNCOPE OR PRE-SYNCOPE
|
0.71%
3/422 • Number of events 3
|
0.72%
3/419 • Number of events 3
|
|
Nervous system disorders
OTHER NEUROLOGICAL DISORDER OR COMPLICATION
|
7.3%
31/422 • Number of events 38
|
9.3%
39/419 • Number of events 46
|
|
Infections and infestations
URINARY TRACT INFECTION
|
17.3%
73/422 • Number of events 81
|
17.2%
72/419 • Number of events 83
|
|
Renal and urinary disorders
HEMATURIA
|
4.5%
19/422 • Number of events 19
|
4.3%
18/419 • Number of events 18
|
|
Renal and urinary disorders
RENAL INSUFFICIENCY
|
2.6%
11/422 • Number of events 12
|
1.9%
8/419 • Number of events 9
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.47%
2/422 • Number of events 2
|
0.72%
3/419 • Number of events 3
|
|
Renal and urinary disorders
UROGENITAL INCONTINENCE (WAS 410)
|
1.4%
6/422 • Number of events 6
|
1.2%
5/419 • Number of events 5
|
|
Renal and urinary disorders
URINARY RETENTION
|
2.6%
11/422 • Number of events 13
|
2.9%
12/419 • Number of events 13
|
|
Renal and urinary disorders
OTHER UROGENITAL DISORDER OR COMPLICATION
|
5.0%
21/422 • Number of events 23
|
6.0%
25/419 • Number of events 31
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.95%
4/422 • Number of events 4
|
0.48%
2/419 • Number of events 2
|
|
Injury, poisoning and procedural complications
INFILTRATION OF IV SITE
|
0.24%
1/422 • Number of events 1
|
0.95%
4/419 • Number of events 4
|
|
Injury, poisoning and procedural complications
SURGICAL SITE INFECTION
|
0.47%
2/422 • Number of events 2
|
0.24%
1/419 • Number of events 1
|
|
Injury, poisoning and procedural complications
SURGICAL WOUND HEMATOMA
|
0.47%
2/422 • Number of events 2
|
0.72%
3/419 • Number of events 3
|
|
Injury, poisoning and procedural complications
OTHER NON-INFECTIOUS SURGICAL WOUND COMPLICATION
|
0.95%
4/422 • Number of events 4
|
1.2%
5/419 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCERS/PRESSURE SORES
|
0.71%
3/422 • Number of events 3
|
1.9%
8/419 • Number of events 9
|
|
Injury, poisoning and procedural complications
BLISTER
|
0.00%
0/422
|
0.48%
2/419 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM (EXCEPT SKIN)
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM (SKIN)
|
0.24%
1/422 • Number of events 1
|
0.00%
0/419
|
|
Injury, poisoning and procedural complications
ACCIDENTAL TRAUMA
|
0.00%
0/422
|
0.24%
1/419 • Number of events 1
|
|
Psychiatric disorders
PSYCHIATRIC DEPRESSION
|
7.6%
32/422 • Number of events 34
|
8.4%
35/419 • Number of events 35
|
|
Injury, poisoning and procedural complications
FALL
|
3.3%
14/422 • Number of events 15
|
3.1%
13/419 • Number of events 15
|
|
General disorders
PERIPHERAL EDEMA
|
3.8%
16/422 • Number of events 19
|
3.8%
16/419 • Number of events 23
|
|
Investigations
OTHER ENZYME/S ELEVATION
|
0.71%
3/422 • Number of events 3
|
0.48%
2/419 • Number of events 3
|
|
Psychiatric disorders
INSOMNIA
|
4.5%
19/422 • Number of events 19
|
6.9%
29/419 • Number of events 30
|
|
Vascular disorders
"HEMATOMA, NOT OTHERWISE SPECIFIED"
|
2.8%
12/422 • Number of events 12
|
1.9%
8/419 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.95%
4/422 • Number of events 5
|
1.4%
6/419 • Number of events 6
|
|
Psychiatric disorders
PSYCHIATRIC DISORDER
|
0.47%
2/422 • Number of events 2
|
1.2%
5/419 • Number of events 5
|
|
Infections and infestations
CELLULITIS/NON-SURGICAL SKIN INFECTION
|
3.3%
14/422 • Number of events 16
|
2.6%
11/419 • Number of events 14
|
|
General disorders
OTHER UNCLASSIFIED ADVERSE EVENT
|
9.5%
40/422 • Number of events 49
|
9.5%
40/419 • Number of events 54
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place