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Interventional Management of Stroke (IMS) III Trial (IMSIII)

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ClinicalTrials.gov Identifier: NCT00359424
Recruitment Status : Terminated (NINDS/NIH-DSMB recommended halting trial due to futility, no safety concerns.)
First Posted : August 2, 2006
Results First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Medical University of South Carolina
University of Calgary
Information provided by (Responsible Party):
Joseph Broderick, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Interventions Drug: IV rt-PA alone
Other: endovascular therapy
Enrollment 656
Recruitment Details

A total of 656 participants underwent randomization

  • participants to endovascular therapy >> and 222 to intravenous t-PA alone) at 58 study >> centers between August 25, 2006, and April 17, >> 2012 in the United States (41 sites), Canada (7), >> Australia (4), and Europe (6)
Pre-assignment Details  
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description Endovascular therapy (group two) received a lower dose (0.09mg per kg bolus and 0.54mg/kilogram infusion over 40 minutes, maximum dose 53.6mg) or after Amendment #5, a standard dose of IV rt-PA (.9mg/kg with 10% as a bolus and the remainder over one hour) and then underwent an angiogram test (cerebral angiography) right after the medicine was given to check for blood clots. If a clot was not seen, then no more treatment was given. If a clot was seen, the neurointerventionalist chose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that would be most effective in reopening the blocked artery. IV rt-PA alone (group one) received the standard dose (.9mg per kilogram with 10% as a bolus and the remainder as an infusion over 1 hour -maximum dose 90mg) of intravenous (IV) rt-PA alone.
Period Title: Overall Study
Started 434 222
90 Day Follow up 343 172
180 Day Follow up 325 167
270 Day Follow up 313 159
Completed 304 155
Not Completed 130 67
Reason Not Completed
Death             99             58
Lost to Follow-up             19             7
Withdrawal by Subject             10             2
follow up not conducted             2             0
Arm/Group Title Endovascular Therapy IV Rt-PA Alone Total
Hide Arm/Group Description Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery. Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour. Total of all reporting groups
Overall Number of Baseline Participants 434 222 656
Hide Baseline Analysis Population Description
A sample of 900 was calculated to provide an effect size of 10 percentage points assuming that 40% of the patients had a good outcome in the IV t-PA group, as noted in patients in the NINDS rt-PA Stroke Study who had age and baseline stroke severity similar to the eligibility criteria for the IMS3 trial. The trial was halted at 656 subjects.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 434 participants 222 participants 656 participants
69
(23 to 89)
68
(23 to 84)
69
(23 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 434 participants 222 participants 656 participants
Female
216
  49.8%
100
  45.0%
316
  48.2%
Male
218
  50.2%
122
  55.0%
340
  51.8%
NIHSS Score   [1] 
Median (Full Range)
Unit of measure:  Score on a scale
Number Analyzed 434 participants 222 participants 656 participants
17
(7 to 40)
16
(8 to 30)
17
(7 to 40)
[1]
Measure Description:

The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher

>> scores indicating greater severity of deficit.

Time from stroke onset to initiation of IV rt-PA   [1] 
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 434 participants 222 participants 656 participants
122.4  (33.7) 121.2  (33.8) 122.0  (33.7)
[1]
Measure Description: Time from stroke onset to initiation of intravenous (IV) rt-PA in minutes.
NIHSS Score Strata  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 434 participants 222 participants 656 participants
NIHSS Score <20 302 150 452
NIHSS Score > = 20 132 72 204
1.Primary Outcome
Title Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.
Hide Description The modified Rankin Scale (mRS) runs from 0-6 running from 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. Persons with a Rankin of 0-2 are considered functionally independent.
Time Frame at 90 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was conducted according to intention to treat. All subjects were analyzed in the treatment group to which they were randomized. Subjects with missing mRS (n=9 in group two; n=4 in group one) or mRS assessed <60 days or >120 days post-randomization (n=10 in group two; n=4 in group one) are assigned an unfavorable outcome(mRS >2)
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
mRS 0-2 177 86
mRS 3-6 257 136
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endovascular Therapy, IV Rt-PA Alone
Comments Test of null hypothesis (equal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .7031
Comments The CMH statistic is tested at the two-sided alpha level of 0.05. For the interim analyses of the primary efficacy analysis, the alpha spending function method (Lan and DeMets, 1987) with O'Brien and Fleming (1979) stopping boundaries were adopted.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (<20 or ≥20).
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-6.1 to 9.1
Estimation Comments Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.
2.Primary Outcome
Title Death Due to Any Cause
Hide Description [Not Specified]
Time Frame within 90 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis includes all subjects who were randomized, and each subject analyzed according to the treatment group to which they were randomly assigned. Subjects who ended the study prior to 90 days post- randomization for a reason other than death (LTFU etc) (n=8 in group two; n=2 in group one) are assumed to be alive
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
83 48
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endovascular Therapy, IV Rt-PA Alone
Comments Test of null hypothesis (equal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .5241
Comments The CMH statistic is tested at the two-sided alpha level of 0.01.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (<20 or ≥20).
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -2.0
Confidence Interval (2-Sided) 99%
-10.3 to 6.2
Estimation Comments Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.
3.Primary Outcome
Title Symptomatic Intracranial Hemorrhage
Hide Description Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site
Time Frame within the first 30 hours post IV rt-PA
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
27 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endovascular Therapy, IV Rt-PA Alone
Comments Test of null hypothesis (equal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .8275
Comments The CMH statistic is tested at the two-sided alpha level of 0.01.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (<20 or ≥20).
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value .4
Confidence Interval (2-Sided) 99%
-4.6 to 5.5
Estimation Comments Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.
4.Secondary Outcome
Title Incidence of Parenchymal Type II (PH2) Hematomas
Hide Description a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans.
Time Frame within 30 hours post IV rt-PA
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were excluded if a post-baseline CT scan was not obtained within 30 hours of randomization (i.e., participants who died, had care withdrawn at the request of the family, or underwent imaging after the 30-hour window).
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 417 207
Measure Type: Number
Unit of Measure: participants
25 13
5.Secondary Outcome
Title Asymptomatic Intracranial Hemorrhage
Hide Description Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site.
Time Frame within 30 hours post IV rt-PA
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned.
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
119 42
6.Secondary Outcome
Title National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.
Hide Description

The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that >> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher

>> scores indicating greater severity of deficit.

Time Frame at 24 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <18 hours or >30 hours post-randomization are assigned an unfavorable outcome (NIHSS score>1).
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
NIHSS 0-1 44 22
NIHSS 2+ 390 200
7.Secondary Outcome
Title National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.
Hide Description The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit.
Time Frame at 90 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (NIHSS score>1).
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
NIHSSS 0-1 120 50
NIHSSS 2+ 314 172
8.Secondary Outcome
Title Barthel Index (BI) Dichotomized 0-90 Versus 95-100
Hide Description 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 lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence.
Time Frame at 90 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing BI and BI measured <60 days or >120 days post-randomization are assigned an unfavorable outcome (BI 0-90).
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
BI 95-100 183 86
BI 0-90 251 136
9.Secondary Outcome
Title Trail Making Test Part A Time
Hide Description 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 each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.
Time Frame 90 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part A.
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 244 127
Mean (Standard Deviation)
Unit of Measure: seconds
84.2  (64.3) 82.0  (62.3)
10.Secondary Outcome
Title Trail Making Test Part B Time
Hide Description 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 each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.
Time Frame at 90 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part B.
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 183 92
Mean (Standard Deviation)
Unit of Measure: seconds
143.8  (75.3) 141.3  (78.4)
11.Secondary Outcome
Title Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
Hide Description The modified Rankin Scale (mRS) runs from 0-6 running from 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. Persons with a Rankin of 0-2 are considered functionally independent.
Time Frame at 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <150 days or >210 days post-randomization are assigned an unfavorable outcome (mRS>2).
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
mRS 0-2 179 86
mRS 3-6 255 136
12.Secondary Outcome
Title Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
Hide Description The modified Rankin Scale (mRS) runs from 0-6 running from 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. Persons with a Rankin of 0-2 are considered functionally independent.
Time Frame 270 days
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <240 days or >300 days post-randomization are assigned an unfavorable outcome (mRS>2).
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
mRS 0-2 177 88
mRS 3-6 257 134
13.Secondary Outcome
Title Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
Hide Description The modified Rankin Scale (mRS) runs from 0-6 running from 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. Persons with a Rankin of 0-2 are considered functionally independent.
Time Frame 360 days post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing mRS and mRS measured <330 days or >390 days post-randomization are assigned an unfavorable outcome (mRS>2).
Arm/Group Title Endovascular Therapy IV Rt-PA Alone
Hide Arm/Group Description:
Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
Overall Number of Participants Analyzed 434 222
Measure Type: Number
Unit of Measure: participants
mRS 0-2 191 95
mRS 3-6 243 127
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endovascular IV Only
Hide Arm/Group Description Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) rightafter the medicine is given to check for blood clots. If a clot is not seenthen no more treatment will be given. If a clot is seen, theneurointerventionalist will then choose (based on the location andextent of the blood clot) a protocol approved endovascular treatmentgiven directly in the brain artery that will be most effective inreopening the blocked artery. Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
All-Cause Mortality
Endovascular IV Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Endovascular IV Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   256/434 (58.99%)      126/222 (56.76%)    
Blood and lymphatic system disorders     
Anaemia  1  4/434 (0.92%)  4 4/222 (1.80%)  4
Coagulopathy  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Disseminated intravascular coagulation  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Hypoprothrombinaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Iron deficiency anaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Thrombocytopenia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Angina pectoris  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Atrial fibrillation  1  7/434 (1.61%)  8 5/222 (2.25%)  5
Atrial flutter  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Atrial tachycardia  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Cardiac arrest  1  8/434 (1.84%)  9 4/222 (1.80%)  4
Cardiac failure  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Cardiac failure acute  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Cardiac failure congestive  1  4/434 (0.92%)  4 4/222 (1.80%)  4
Cardiac valve vegetation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardio-respiratory arrest  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Cardiogenic shock  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Cardiomyopathy  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiopulmonary failure  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Coronary artery disease  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Electromechanical dissociation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Endocarditis noninfective  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Intracardiac thrombus  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Ischaemic cardiomyopathy  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Mitral valve disease  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Mitral valve stenosis  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Myocardial infarction  1  4/434 (0.92%)  4 0/222 (0.00%)  0
Pericardial effusion  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pericardial haemorrhage  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Sick sinus syndrome  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Sinus bradycardia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Tachyarrhythmia  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Tachycardia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Ventricular tachycardia  1  2/434 (0.46%)  2 4/222 (1.80%)  4
Congenital, familial and genetic disorders     
Atrial septal defect  1  4/434 (0.92%)  4 1/222 (0.45%)  1
Hereditary cerebral degeneration  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Eye disorders     
Diplopia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Colitis  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Diarrhoea  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Gastritis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Gastrointestinal haemorrhage  1  2/434 (0.46%)  2 3/222 (1.35%)  3
Gastrooesophageal reflux disease  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Gingival bleeding  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Haematemesis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haematochezia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Ileus  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Intestinal obstruction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pancreatic mass  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pancreatitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Peritonitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Retroperitoneal haematoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Retroperitoneal haemorrhage  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Small intestinal obstruction  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Umbilical hernia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
General disorders     
Brain death  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Chest discomfort  1  3/434 (0.69%)  4 0/222 (0.00%)  0
Chest pain  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Extravasation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
General physical health deterioration  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Multi-organ failure  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Non-cardiac chest pain  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Oedema due to cardiac disease  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Oedema peripheral  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pyrexia  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Systemic inflammatory response syndrome  1  0/434 (0.00%)  0 2/222 (0.90%)  2
Vessel puncture site haematoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Vessel puncture site haemorrhage  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Infections and infestations     
Abdominal wall infection  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Appendicitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Bacteraemia  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Bacteriuria  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cellulitis  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Clostridium difficile colitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Endocarditis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Endocarditis bacterial  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Gangrene  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Gastroenteritis  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Haematoma infection  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Infected skin ulcer  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Infection  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Lobar pneumonia  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Lung infection pseudomonal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pneumonia  1  16/434 (3.69%)  17 8/222 (3.60%)  8
Pneumonia primary atypical  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Postoperative wound infection  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Pulmonary sepsis  1  0/434 (0.00%)  0 2/222 (0.90%)  2
Respiratory tract infection  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Sepsis  1  6/434 (1.38%)  6 5/222 (2.25%)  5
Sepsis syndrome  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Septic shock  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Urinary tract infection  1  8/434 (1.84%)  11 7/222 (3.15%)  7
Urosepsis  1  2/434 (0.46%)  2 2/222 (0.90%)  2
Wound infection  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Injury, poisoning and procedural complications     
Aortic injury  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Arterial injury  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Brain herniation  1  7/434 (1.61%)  7 2/222 (0.90%)  3
Cardiac procedure complication  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cervical vertebral fracture  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Concussion  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Difficult to wean from ventilator  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Drug dispensing error  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Fall  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Feeding tube complication  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Femoral neck fracture  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Femur fracture  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Head injury  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Hip fracture  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Injury  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Medication error  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Post procedural haematoma  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Rib fracture  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Stent occlusion  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Subdural haematoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Thermal burn  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Thrombosis in device  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Vascular injury  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Vascular procedure complication  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Ventriculoperitoneal shunt malfunction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood culture positive  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood glucose increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood magnesium decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood osmolarity decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood phosphorus decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Computerised tomogram abnormal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Electrocardiogram ST segment abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Electroencephalogram abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Haematocrit decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
NIH stroke scale score increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Oxygen saturation decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Troponin increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Weight decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Metabolism and nutrition disorders     
Acid-base balance disorder mixed  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Anorexia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Dehydration  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Diabetes mellitus insulin-dependent  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Failure to thrive  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Hyperglycaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hypokalaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Muscular weakness  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Osteoarthritis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Pain in extremity  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pain in jaw  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Glioblastoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Gliomatosis cerebri  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Lung adenocarcinoma  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Lung neoplasm malignant  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Metastatic neoplasm  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Prostate cancer  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Brain compression  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Brain oedema  1  46/434 (10.60%)  46 19/222 (8.56%)  20
Brain stem infarction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Carotid artery dissection  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Carotid artery occlusion  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Carotid artery stenosis  1  0/434 (0.00%)  0 2/222 (0.90%)  2
Cerebellar haemorrhage  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cerebellar infarction  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Cerebral haematoma  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Cerebral haemorrhage  1  8/434 (1.84%)  8 8/222 (3.60%)  8
Cerebral infarction  1  9/434 (2.07%)  9 1/222 (0.45%)  1
Cerebrovascular accident  1  18/434 (4.15%)  19 12/222 (5.41%)  12
Cerebrovascular disorder  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Coma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Complex partial seizures  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Convulsion  1  9/434 (2.07%)  9 9/222 (4.05%)  9
Depressed level of consciousness  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Dizziness  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Encephalopathy  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Facial spasm  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haemorrhage intracranial  1  12/434 (2.76%)  12 8/222 (3.60%)  8
Haemorrhagic cerebral infarction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haemorrhagic stroke  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haemorrhagic transformation stroke  1  6/434 (1.38%)  6 6/222 (2.70%)  6
Headache  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hemiparesis  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Hydrocephalus  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Intracranial haematoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Intracranial pressure increased  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Intraventricular haemorrhage  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Ischaemic stroke  1  6/434 (1.38%)  7 2/222 (0.90%)  2
Lethargy  1  0/434 (0.00%)  0 3/222 (1.35%)  3
Mental impairment  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Migraine  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Neurological symptom  1  12/434 (2.76%)  13 4/222 (1.80%)  4
Presyncope  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Status epilepticus  1  1/434 (0.23%)  2 0/222 (0.00%)  0
Stroke in evolution  1  0/434 (0.00%)  0 2/222 (0.90%)  2
Subarachnoid haemorrhage  1  6/434 (1.38%)  6 0/222 (0.00%)  0
Syncope  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Thalamic infarction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Transient ischaemic attack  1  3/434 (0.69%)  3 2/222 (0.90%)  2
Tremor  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Psychiatric disorders     
Aggression  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Agitation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Anxiety  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Confusional state  1  1/434 (0.23%)  2 0/222 (0.00%)  0
Delirium tremens  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Depression  1  0/434 (0.00%)  0 2/222 (0.90%)  2
Emotional disorder  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Mental status changes  1  6/434 (1.38%)  7 2/222 (0.90%)  2
Suicide attempt  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Renal and urinary disorders     
Haematuria  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Nephrolithiasis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Renal failure  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Renal failure acute  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Renal failure chronic  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Renal mass  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Urinary retention  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Reproductive system and breast disorders     
Pelvic pain  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  3/434 (0.69%)  3 1/222 (0.45%)  2
Acute respiratory distress syndrome  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Acute respiratory failure  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Apnoea  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Aspiration  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Atelectasis  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Dyspnoea  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Epistaxis  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Haemoptysis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Hypoxia  1  5/434 (1.15%)  5 0/222 (0.00%)  0
Lung infiltration  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Obstructive airways disorder  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Pneumonia aspiration  1  6/434 (1.38%)  6 2/222 (0.90%)  2
Pneumothorax  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Pulmonary embolism  1  4/434 (0.92%)  4 8/222 (3.60%)  8
Pulmonary haemorrhage  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pulmonary oedema  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Respiratory arrest  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Respiratory distress  1  5/434 (1.15%)  5 4/222 (1.80%)  4
Respiratory failure  1  18/434 (4.15%)  18 5/222 (2.25%)  5
Skin and subcutaneous tissue disorders     
Angioneurotic oedema  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Decubitus ulcer  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Skin ulcer  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Surgical and medical procedures     
Aortic valve replacement  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiac pacemaker insertion  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Cardiac pacemaker replacement  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Carotid endarterectomy  1  2/434 (0.46%)  2 2/222 (0.90%)  3
Cholecystectomy  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Craniectomy  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Cranioplasty  1  9/434 (2.07%)  9 3/222 (1.35%)  3
Intubation  1  0/434 (0.00%)  0 1/222 (0.45%)  2
Medical device implantation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Mitral valve replacement  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Nephrectomy  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Surgery  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Tracheostomy  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Vascular disorders     
Aortic arteriosclerosis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Aortic stenosis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Arterial restenosis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Arterial thrombosis limb  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Deep vein thrombosis  1  7/434 (1.61%)  7 2/222 (0.90%)  2
Femoral artery occlusion  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Haematoma  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Haemodynamic instability  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haemorrhage  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Hypertension  1  4/434 (0.92%)  4 2/222 (0.90%)  2
Hypertensive crisis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hypertensive emergency  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Hypotension  1  6/434 (1.38%)  6 6/222 (2.70%)  6
Iliac artery thrombosis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Peripheral arterial occlusive disease  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Peripheral artery aneurysm  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Peripheral embolism  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Peripheral ischaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Peripheral vascular disorder  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Shock  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Thrombophlebitis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.X
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Endovascular IV Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   385/434 (88.71%)      202/222 (90.99%)    
Blood and lymphatic system disorders     
Anaemia  1  39/434 (8.99%)  41 16/222 (7.21%)  17
Coagulopathy  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Haemorrhagic disorder  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hilar lymphadenopathy  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Iron deficiency anaemia  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Leukocytosis  1  7/434 (1.61%)  7 5/222 (2.25%)  5
Lymphadenopathy  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Lymphadenopathy mediastinal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pernicious anaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Splenic infarction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Thrombocytopenia  1  5/434 (1.15%)  5 5/222 (2.25%)  5
Cardiac disorders     
Acute myocardial infarction  1  4/434 (0.92%)  4 0/222 (0.00%)  0
Angina pectoris  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Aortic valve disease  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Aortic valve stenosis  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Arrhythmia  1  4/434 (0.92%)  4 1/222 (0.45%)  1
Arrhythmia supraventricular  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Atrial fibrillation  1  37/434 (8.53%)  41 21/222 (9.46%)  22
Atrial flutter  1  3/434 (0.69%)  4 1/222 (0.45%)  1
Atrioventricular block  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Bradycardia  1  18/434 (4.15%)  19 9/222 (4.05%)  9
Bundle branch block right  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiac disorder  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Cardiac failure  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Cardiac failure acute  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiac failure congestive  1  16/434 (3.69%)  17 7/222 (3.15%)  8
Cardiac valve disease  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Cardiac valve vegetation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiogenic shock  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiomegaly  1  2/434 (0.46%)  2 2/222 (0.90%)  2
Cardiomyopathy  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Cardiovascular disorder  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Coronary artery disease  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Diastolic dysfunction  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Intracardiac thrombus  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Ischaemic cardiomyopathy  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Mitral valve stenosis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Myocardial infarction  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Myocardial ischaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Nodal arrhythmia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Palpitations  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Sick sinus syndrome  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Sinus arrhythmia  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Sinus bradycardia  1  2/434 (0.46%)  2 7/222 (3.15%)  7
Sinus tachycardia  1  4/434 (0.92%)  4 1/222 (0.45%)  1
Supraventricular tachycardia  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Tachycardia  1  15/434 (3.46%)  16 9/222 (4.05%)  9
Ventricular arrhythmia  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Ventricular extrasystoles  1  4/434 (0.92%)  4 1/222 (0.45%)  1
Ventricular tachycardia  1  6/434 (1.38%)  6 3/222 (1.35%)  3
Congenital, familial and genetic disorders     
Atrial septal defect  1  3/434 (0.69%)  3 2/222 (0.90%)  2
Congenital cystic kidney disease  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Homocystinaemia  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Ear and labyrinth disorders     
Cerumen impaction  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Deafness  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Ear pain  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Vertigo  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Endocrine disorders     
Diabetes insipidus  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hypothyroidism  1  1/434 (0.23%)  1 3/222 (1.35%)  3
Eye disorders     
Conjunctival haemorrhage  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Conjunctivitis  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Dry eye  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Eye disorder  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Eye pain  1  1/434 (0.23%)  2 2/222 (0.90%)  2
Eye swelling  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Eyelid oedema  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Eyelid ptosis  1  2/434 (0.46%)  3 0/222 (0.00%)  0
Ocular hyperaemia  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Pupil fixed  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Scleral oedema  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Ulcerative keratitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Vision blurred  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Abdominal distension  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Abdominal pain  1  8/434 (1.84%)  8 2/222 (0.90%)  2
Abdominal pain upper  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Abnormal faeces  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Anal haemorrhage  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Ascites  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Bowel movement irregularity  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Constipation  1  41/434 (9.45%)  43 26/222 (11.71%)  27
Diarrhoea  1  21/434 (4.84%)  21 9/222 (4.05%)  9
Dyspepsia  1  8/434 (1.84%)  8 4/222 (1.80%)  4
Dysphagia  1  14/434 (3.23%)  14 3/222 (1.35%)  3
Faecal incontinence  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Flatulence  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Food poisoning  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Gastritis  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Gastritis haemorrhagic  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Gastrointestinal haemorrhage  1  5/434 (1.15%)  5 3/222 (1.35%)  3
Gastrooesophageal reflux disease  1  6/434 (1.38%)  6 2/222 (0.90%)  2
Gingival bleeding  1  3/434 (0.69%)  3 6/222 (2.70%)  6
Gingivitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haematemesis  1  4/434 (0.92%)  4 2/222 (0.90%)  2
Haematochezia  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Haemorrhoids  1  5/434 (1.15%)  5 1/222 (0.45%)  1
Hiatus hernia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hypoaesthesia oral  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Ileus  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Impaired gastric emptying  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Inguinal hernia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Loose tooth  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Melaena  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Mouth haemorrhage  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Nausea  1  43/434 (9.91%)  45 17/222 (7.66%)  18
Oesophageal stenosis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Periproctitis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Rectal haemorrhage  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Retroperitoneal haematoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Salivary hypersecretion  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Stomach discomfort  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Swollen tongue  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Tongue haemorrhage  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Tongue ulceration  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Toothache  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Vomiting  1  39/434 (8.99%)  40 21/222 (9.46%)  22
General disorders     
Adverse drug reaction  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Asthenia  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Catheter site bruise  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Catheter site haemorrhage  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Catheter site related reaction  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Chest discomfort  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Chest pain  1  17/434 (3.92%)  17 9/222 (4.05%)  10
Chills  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Discomfort  1  4/434 (0.92%)  4 1/222 (0.45%)  1
Extravasation  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Face oedema  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Facial pain  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Fatigue  1  10/434 (2.30%)  10 2/222 (0.90%)  2
Feeling cold  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Generalised oedema  1  4/434 (0.92%)  4 3/222 (1.35%)  3
Hyperthermia  1  0/434 (0.00%)  0 2/222 (0.90%)  2
Implant site pain  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Infusion site erythema  1  1/434 (0.23%)  2 0/222 (0.00%)  0
Infusion site haemorrhage  1  4/434 (0.92%)  4 3/222 (1.35%)  3
Infusion site oedema  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Injection site extravasation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Local swelling  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Malaise  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Mass  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Non-cardiac chest pain  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Oedema peripheral  1  23/434 (5.30%)  29 13/222 (5.86%)  15
Pain  1  30/434 (6.91%)  32 14/222 (6.31%)  16
Pitting oedema  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Puncture site haemorrhage  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Pyrexia  1  35/434 (8.06%)  36 31/222 (13.96%)  32
Swelling  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Systemic inflammatory response syndrome  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Vessel puncture site bruise  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Vessel puncture site haematoma  1  15/434 (3.46%)  15 1/222 (0.45%)  1
Vessel puncture site haemorrhage  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Hepatobiliary disorders     
Cholecystitis acute  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hepatomegaly  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Immune system disorders     
Drug hypersensitivity  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hypersensitivity  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Infections and infestations     
Abdominal wall abscess  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Abscess limb  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Bacteraemia  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Bronchitis  1  4/434 (0.92%)  4 4/222 (1.80%)  4
Bronchitis acute  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Candidiasis  1  4/434 (0.92%)  4 1/222 (0.45%)  1
Cellulitis  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Chest wall abscess  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Clostridial infection  1  4/434 (0.92%)  4 3/222 (1.35%)  3
Clostridium difficile colitis  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Cystitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Diarrhoea infectious  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Enterococcal infection  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Eye infection  1  2/434 (0.46%)  2 2/222 (0.90%)  2
Fungal infection  1  5/434 (1.15%)  5 1/222 (0.45%)  1
Fungal skin infection  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Gastroenteritis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Herpes simplex  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Herpes zoster  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Infection  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Infusion site infection  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Lobar pneumonia  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Lower respiratory tract infection  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Lymphadenitis bacterial  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Nail infection  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Nasopharyngitis  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Onychomycosis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Oral candidiasis  1  16/434 (3.69%)  16 6/222 (2.70%)  6
Oral fungal infection  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Orchitis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Pneumonia  1  36/434 (8.29%)  39 8/222 (3.60%)  8
Pneumonia staphylococcal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pneumonia streptococcal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Respiratory tract infection  1  6/434 (1.38%)  6 1/222 (0.45%)  1
Sepsis  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Sinusitis  1  7/434 (1.61%)  7 2/222 (0.90%)  2
Skin infection  1  2/434 (0.46%)  2 2/222 (0.90%)  2
Staphylococcal bacteraemia  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Staphylococcal infection  1  0/434 (0.00%)  0 3/222 (1.35%)  3
Staphylococcal sepsis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Subacute endocarditis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Tooth abscess  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Tracheobronchitis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Upper respiratory tract infection  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Urinary tract infection  1  90/434 (20.74%)  104 46/222 (20.72%)  51
Urinary tract infection bacterial  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Urosepsis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Vaginal candidiasis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Vaginal infection  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Vulvovaginal mycotic infection  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Wound infection  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Wound infection bacterial  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol poisoning  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Brain herniation  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Conjunctival abrasion  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Contrast media reaction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Contusion  1  26/434 (5.99%)  30 9/222 (4.05%)  12
Device lead damage  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Difficult to wean from ventilator  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Drug administration error  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Epicondylitis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Excoriation  1  3/434 (0.69%)  4 2/222 (0.90%)  2
Fall  1  13/434 (3.00%)  15 18/222 (8.11%)  18
Feeding tube complication  1  1/434 (0.23%)  1 1/222 (0.45%)  2
Haematuria traumatic  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hand fracture  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Incision site complication  1  5/434 (1.15%)  5 2/222 (0.90%)  3
Incision site oedema  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Intubation complication  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Joint dislocation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Joint sprain  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Laceration  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Medication error  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Mouth injury  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Muscle strain  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Pacemaker complication  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Periorbital haematoma  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Post procedural haematoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Post procedural haematuria  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Post procedural haemorrhage  1  4/434 (0.92%)  4 1/222 (0.45%)  1
Post-traumatic pain  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Procedural complication  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Procedural hypertension  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Renal injury  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Rib fracture  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Skin injury  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Skin laceration  1  8/434 (1.84%)  9 0/222 (0.00%)  0
Stress fracture  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Tracheostomy malfunction  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Transfusion reaction  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Traumatic fracture  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Traumatic haematoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Upper limb fracture  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Wound  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Wrong technique in drug usage process  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  1  4/434 (0.92%)  4 0/222 (0.00%)  0
Bacteria stool identified  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Blood albumin abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Blood alkaline phosphatase increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood cholesterol increased  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Blood creatine phosphokinase increased  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Blood creatinine increased  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Blood culture positive  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Blood electrolytes abnormal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood fibrinogen decreased  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Blood fibrinogen increased  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Blood glucose abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Blood glucose increased  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Blood lactate dehydrogenase increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood magnesium decreased  1  8/434 (1.84%)  8 3/222 (1.35%)  3
Blood phosphorus decreased  1  2/434 (0.46%)  2 2/222 (0.90%)  2
Blood potassium decreased  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Blood pressure decreased  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Blood pressure increased  1  2/434 (0.46%)  2 2/222 (0.90%)  2
Blood test abnormal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood thyroid stimulating hormone decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood urea abnormal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Blood urea increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Body temperature increased  1  6/434 (1.38%)  6 2/222 (0.90%)  3
Breath sounds abnormal  1  1/434 (0.23%)  1 1/222 (0.45%)  3
C-reactive protein increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiac enzymes increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cardiac stress test abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Chest X-ray abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Computerised tomogram abnormal  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Culture urine positive  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Drug level fluctuating  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Electrocardiogram ST segment abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Electrocardiogram ST segment depression  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Electrocardiogram ST segment elevation  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Electroencephalogram abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Free prostate-specific antigen increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Full blood count abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Haematocrit decreased  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Haematology test abnormal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haemoglobin  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haemoglobin abnormal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haemoglobin decreased  1  8/434 (1.84%)  9 2/222 (0.90%)  2
Heart rate decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Inspiratory capacity decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
International normalised ratio increased  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Myoglobin blood increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
NIH stroke scale score increased  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Neurological examination abnormal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Oxygen saturation decreased  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Platelet count decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Platelet count increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Prothrombin time prolonged  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pulmonary function test decreased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Red blood cell count decreased  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Red blood cell sedimentation rate increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Residual urine volume  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Scan with contrast abnormal  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Troponin I increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Troponin increased  1  10/434 (2.30%)  10 3/222 (1.35%)  3
Urine output decreased  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Urine output increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Venous pressure jugular increased  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Weight decreased  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Weight increased  1  1/434 (0.23%)  1 0/222 (0.00%)  0
White blood cell count increased  1  13/434 (3.00%)  13 3/222 (1.35%)  3
Metabolism and nutrition disorders     
Anorexia  1  1/434 (0.23%)  1 2/222 (0.90%)  2
Appetite disorder  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Dehydration  1  5/434 (1.15%)  5 3/222 (1.35%)  3
Diabetes mellitus  1  3/434 (0.69%)  3 2/222 (0.90%)  2
Diabetes mellitus non-insulin-dependent  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Electrolyte imbalance  1  23/434 (5.30%)  25 7/222 (3.15%)  7
Fluid imbalance  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Fluid overload  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Fluid retention  1  0/434 (0.00%)  0 2/222 (0.90%)  2
Gout  1  3/434 (0.69%)  3 3/222 (1.35%)  3
Hyperammonaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hyperchloraemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hypercholesterolaemia  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Hyperglycaemia  1  31/434 (7.14%)  31 11/222 (4.95%)  11
Hyperhomocysteinaemia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Hyperkalaemia  1  2/434 (0.46%)  2 2/222 (0.90%)  2
Hyperlipidaemia  1  5/434 (1.15%)  5 10/222 (4.50%)  10
Hypernatraemia  1  3/434 (0.69%)  3 3/222 (1.35%)  3
Hypoalbuminaemia  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Hypocalcaemia  1  8/434 (1.84%)  8 1/222 (0.45%)  1
Hypoglycaemia  1  5/434 (1.15%)  5 1/222 (0.45%)  1
Hypokalaemia  1  40/434 (9.22%)  40 18/222 (8.11%)  20
Hypomagnesaemia  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Hyponatraemia  1  14/434 (3.23%)  14 7/222 (3.15%)  7
Hypophosphataemia  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Hypovolaemia  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Lactose intolerance  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Malnutrition  1  3/434 (0.69%)  3 2/222 (0.90%)  2
Metabolic acidosis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Metabolic alkalosis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Vitamin D deficiency  1  5/434 (1.15%)  5 5/222 (2.25%)  5
Musculoskeletal and connective tissue disorders     
Arthralgia  1  22/434 (5.07%)  25 7/222 (3.15%)  7
Back pain  1  23/434 (5.30%)  24 13/222 (5.86%)  13
Buttock pain  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Flank pain  1  4/434 (0.92%)  4 0/222 (0.00%)  0
Groin pain  1  4/434 (0.92%)  4 2/222 (0.90%)  2
Haemarthrosis  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Joint effusion  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Joint swelling  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Limb discomfort  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Monarthritis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Muscle haemorrhage  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Muscle spasms  1  1/434 (0.23%)  1 5/222 (2.25%)  6
Muscle twitching  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Muscular weakness  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Musculoskeletal chest pain  1  2/434 (0.46%)  2 3/222 (1.35%)  3
Musculoskeletal disorder  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Musculoskeletal pain  1  18/434 (4.15%)  18 8/222 (3.60%)  8
Musculoskeletal stiffness  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Myalgia  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Neck pain  1  7/434 (1.61%)  7 5/222 (2.25%)  5
Pain in extremity  1  28/434 (6.45%)  31 12/222 (5.41%)  17
Pain in jaw  1  4/434 (0.92%)  4 0/222 (0.00%)  0
Periarthritis  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Rheumatoid arthritis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Rotator cuff syndrome  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Sacral pain  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Spinal disorder  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Trigger finger  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chondromatosis  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Colon cancer recurrent  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Thyroid neoplasm  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Nervous system disorders     
Amnesia  1  3/434 (0.69%)  3 0/222 (0.00%)  0
Aphasia  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Balance disorder  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Brain oedema  1  10/434 (2.30%)  10 15/222 (6.76%)  16
Carotid arterial embolus  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Carotid artery dissection  1  7/434 (1.61%)  8 0/222 (0.00%)  0
Carotid artery stenosis  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Cerebellar haemorrhage  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Cerebral artery embolism  1  5/434 (1.15%)  5 0/222 (0.00%)  0
Cerebral haemorrhage  1  26/434 (5.99%)  26 7/222 (3.15%)  7
Cerebral infarction  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Cerebrovascular accident  1  4/434 (0.92%)  4 1/222 (0.45%)  2
Cerebrovascular spasm  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Cognitive disorder  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Complex regional pain syndrome  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Convulsion  1  16/434 (3.69%)  19 5/222 (2.25%)  5
Coordination abnormal  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Depressed level of consciousness  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Disturbance in attention  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Dizziness  1  15/434 (3.46%)  17 1/222 (0.45%)  1
Dysgeusia  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Dystonia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Encephalomalacia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Encephalopathy  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Facial palsy  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Grand mal convulsion  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Haemorrhage intracranial  1  43/434 (9.91%)  43 14/222 (6.31%)  14
Haemorrhagic cerebral infarction  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Haemorrhagic stroke  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Haemorrhagic transformation stroke  1  35/434 (8.06%)  35 18/222 (8.11%)  18
Headache  1  80/434 (18.43%)  86 51/222 (22.97%)  55
Hemiparesis  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Hydrocephalus  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Hypoaesthesia  1  3/434 (0.69%)  4 2/222 (0.90%)  2
Intention tremor  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Intracranial aneurysm  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Intracranial haematoma  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Intraventricular haemorrhage  1  2/434 (0.46%)  2 0/222 (0.00%)  0
Lethargy  1  5/434 (1.15%)  6 5/222 (2.25%)  5
Loss of consciousness  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Mental impairment  1  2/434 (0.46%)  2 1/222 (0.45%)  1
Muscle spasticity  1  3/434 (0.69%)  3 2/222 (0.90%)  2
Neurological symptom  1  12/434 (2.76%)  12 5/222 (2.25%)  5
Neuropathy  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Paraesthesia  1  5/434 (1.15%)  5 0/222 (0.00%)  0
Partial seizures  1  3/434 (0.69%)  3 1/222 (0.45%)  1
Presyncope  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Putamen haemorrhage  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Restless legs syndrome  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Sciatica  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Sensory loss  1  1/434 (0.23%)  1 1/222 (0.45%)  1
Somnolence  1  4/434 (0.92%)  4 4/222 (1.80%)  4
Subarachnoid haemorrhage  1  8/434 (1.84%)  8 2/222 (0.90%)  2
Syncope  1  4/434 (0.92%)  4 2/222 (0.90%)  2
Transient ischaemic attack  1  6/434 (1.38%)  6 1/222 (0.45%)  1
Tremor  1  5/434 (1.15%)  5 2/222 (0.90%)  2
Unresponsive to stimuli  1  0/434 (0.00%)  0 1/222 (0.45%)  1
Vascular dementia  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  1/434 (0.23%)  1 0/222 (0.00%)  0
Psychiatric disorders