Trial Outcomes & Findings for Interventional Management of Stroke (IMS) III Trial (NCT NCT00359424)
NCT ID: NCT00359424
Last Updated: 2013-12-13
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
656 participants
Primary outcome timeframe
at 90 days post randomization
Results posted on
2013-12-13
Participant Flow
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)
Participant milestones
| Measure |
Endovascular Therapy
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
434
|
222
|
|
Overall Study
90 Day Follow up
|
343
|
172
|
|
Overall Study
180 Day Follow up
|
325
|
167
|
|
Overall Study
270 Day Follow up
|
313
|
159
|
|
Overall Study
COMPLETED
|
304
|
155
|
|
Overall Study
NOT COMPLETED
|
130
|
67
|
Reasons for withdrawal
| Measure |
Endovascular Therapy
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
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.
|
|---|---|---|
|
Overall Study
Death
|
99
|
58
|
|
Overall Study
Lost to Follow-up
|
19
|
7
|
|
Overall Study
Withdrawal by Subject
|
10
|
2
|
|
Overall Study
follow up not conducted
|
2
|
0
|
Baseline Characteristics
Interventional Management of Stroke (IMS) III Trial
Baseline characteristics by cohort
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
Total
n=656 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
68 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
218 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
|
NIHSS Score
|
17 Score on a scale
n=5 Participants
|
16 Score on a scale
n=7 Participants
|
17 Score on a scale
n=5 Participants
|
|
Time from stroke onset to initiation of IV rt-PA
|
122.4 minutes
STANDARD_DEVIATION 33.7 • n=5 Participants
|
121.2 minutes
STANDARD_DEVIATION 33.8 • n=7 Participants
|
122.0 minutes
STANDARD_DEVIATION 33.7 • n=5 Participants
|
|
NIHSS Score Strata
NIHSS Score <20
|
302 participants
n=5 Participants
|
150 participants
n=7 Participants
|
452 participants
n=5 Participants
|
|
NIHSS Score Strata
NIHSS Score > = 20
|
132 participants
n=5 Participants
|
72 participants
n=7 Participants
|
204 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 90 days post randomizationPopulation: 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)
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.
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.
mRS 0-2
|
177 participants
|
86 participants
|
|
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2.
mRS 3-6
|
257 participants
|
136 participants
|
PRIMARY outcome
Timeframe: within 90 days post randomizationPopulation: 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
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Death Due to Any Cause
|
83 participants
|
48 participants
|
PRIMARY outcome
Timeframe: within the first 30 hours post IV rt-PAPopulation: 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.
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
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Symptomatic Intracranial Hemorrhage
|
27 participants
|
13 participants
|
SECONDARY outcome
Timeframe: within 30 hours post IV rt-PAPopulation: 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).
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.
Outcome measures
| Measure |
Endovascular Therapy
n=417 Participants
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.
|
IV Rt-PA Alone
n=207 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Incidence of Parenchymal Type II (PH2) Hematomas
|
25 participants
|
13 participants
|
SECONDARY outcome
Timeframe: within 30 hours post IV rt-PAPopulation: 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.
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.
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Asymptomatic Intracranial Hemorrhage
|
119 participants
|
42 participants
|
SECONDARY outcome
Timeframe: at 24 hours post randomizationPopulation: 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).
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.
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.
NIHSS 0-1
|
44 participants
|
22 participants
|
|
National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater.
NIHSS 2+
|
390 participants
|
200 participants
|
SECONDARY outcome
Timeframe: at 90 days post randomizationPopulation: 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).
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.
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.
NIHSSS 0-1
|
120 participants
|
50 participants
|
|
National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater.
NIHSSS 2+
|
314 participants
|
172 participants
|
SECONDARY outcome
Timeframe: at 90 days post randomizationPopulation: 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).
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.
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Barthel Index (BI) Dichotomized 0-90 Versus 95-100
BI 95-100
|
183 participants
|
86 participants
|
|
Barthel Index (BI) Dichotomized 0-90 Versus 95-100
BI 0-90
|
251 participants
|
136 participants
|
SECONDARY outcome
Timeframe: 90 days post randomizationPopulation: Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part A.
The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes.
Outcome measures
| Measure |
Endovascular Therapy
n=244 Participants
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.
|
IV Rt-PA Alone
n=127 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Trail Making Test Part A Time
|
84.2 seconds
Standard Deviation 64.3
|
82.0 seconds
Standard Deviation 62.3
|
SECONDARY outcome
Timeframe: at 90 days post randomizationPopulation: Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part B.
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.
Outcome measures
| Measure |
Endovascular Therapy
n=183 Participants
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.
|
IV Rt-PA Alone
n=92 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Trail Making Test Part B Time
|
143.8 seconds
Standard Deviation 75.3
|
141.3 seconds
Standard Deviation 78.4
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: 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).
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.
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
mRS 0-2
|
179 participants
|
86 participants
|
|
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
mRS 3-6
|
255 participants
|
136 participants
|
SECONDARY outcome
Timeframe: 270 daysPopulation: 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).
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.
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
mRS 0-2
|
177 participants
|
88 participants
|
|
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
mRS 3-6
|
257 participants
|
134 participants
|
SECONDARY outcome
Timeframe: 360 days post randomizationPopulation: 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).
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.
Outcome measures
| Measure |
Endovascular Therapy
n=434 Participants
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.
|
IV Rt-PA Alone
n=222 Participants
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
mRS 0-2
|
191 participants
|
95 participants
|
|
Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2
mRS 3-6
|
243 participants
|
127 participants
|
Adverse Events
Endovascular
Serious events: 256 serious events
Other events: 385 other events
Deaths: 0 deaths
IV Only
Serious events: 126 serious events
Other events: 202 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Endovascular
n=434 participants at risk
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.
|
IV Only
n=222 participants at risk
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.92%
4/434 • Number of events 4
|
1.8%
4/222 • Number of events 4
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Acute myocardial infarction
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
7/434 • Number of events 8
|
2.3%
5/222 • Number of events 5
|
|
Cardiac disorders
Atrial flutter
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Cardiac disorders
Atrial tachycardia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
1.8%
8/434 • Number of events 9
|
1.8%
4/222 • Number of events 4
|
|
Cardiac disorders
Cardiac failure
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Cardiac failure acute
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.92%
4/434 • Number of events 4
|
1.8%
4/222 • Number of events 4
|
|
Cardiac disorders
Cardiac valve vegetation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Cardiac disorders
Cardiogenic shock
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Cardiac disorders
Cardiomyopathy
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Electromechanical dissociation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Endocarditis noninfective
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Intracardiac thrombus
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Mitral valve disease
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Cardiac disorders
Mitral valve stenosis
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
4/434 • Number of events 4
|
0.00%
0/222
|
|
Cardiac disorders
Pericardial effusion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Sick sinus syndrome
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Cardiac disorders
Sinus bradycardia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Ventricular tachycardia
|
0.46%
2/434 • Number of events 2
|
1.8%
4/222 • Number of events 4
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Congenital, familial and genetic disorders
Hereditary cerebral degeneration
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Colitis
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Gastrointestinal disorders
Diarrhoea
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.46%
2/434 • Number of events 2
|
1.4%
3/222 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Haematochezia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Ileus
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Peritonitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Brain death
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Chest discomfort
|
0.69%
3/434 • Number of events 4
|
0.00%
0/222
|
|
General disorders
Chest pain
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Extravasation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
General physical health deterioration
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
General disorders
Non-cardiac chest pain
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Oedema due to cardiac disease
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Pyrexia
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
General disorders
Vessel puncture site haematoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Vessel puncture site haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Immune system disorders
Anaphylactic reaction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Abdominal wall infection
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Bacteriuria
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Cellulitis
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Infections and infestations
Clostridium difficile colitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Endocarditis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Endocarditis bacterial
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Gangrene
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Infections and infestations
Haematoma infection
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Infected skin ulcer
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Infection
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Lung infection pseudomonal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Pneumonia
|
3.7%
16/434 • Number of events 17
|
3.6%
8/222 • Number of events 8
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Infections and infestations
Sepsis
|
1.4%
6/434 • Number of events 6
|
2.3%
5/222 • Number of events 5
|
|
Infections and infestations
Sepsis syndrome
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Septic shock
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
1.8%
8/434 • Number of events 11
|
3.2%
7/222 • Number of events 7
|
|
Infections and infestations
Urosepsis
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Infections and infestations
Wound infection
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Brain herniation
|
1.6%
7/434 • Number of events 7
|
0.90%
2/222 • Number of events 3
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Concussion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Difficult to wean from ventilator
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Drug dispensing error
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Injury
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Stent occlusion
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Ventriculoperitoneal shunt malfunction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood culture positive
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood glucose increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood magnesium decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood osmolarity decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood phosphorus decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Computerised tomogram abnormal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Electroencephalogram abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
NIH stroke scale score increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Oxygen saturation decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Troponin increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Weight decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Acid-base balance disorder mixed
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Dehydration
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus insulin-dependent
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gliomatosis cerebri
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Aphasia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Brain compression
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Brain oedema
|
10.6%
46/434 • Number of events 46
|
8.6%
19/222 • Number of events 20
|
|
Nervous system disorders
Brain stem infarction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Carotid artery dissection
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Nervous system disorders
Carotid artery occlusion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Cerebellar infarction
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.8%
8/434 • Number of events 8
|
3.6%
8/222 • Number of events 8
|
|
Nervous system disorders
Cerebral infarction
|
2.1%
9/434 • Number of events 9
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
4.1%
18/434 • Number of events 19
|
5.4%
12/222 • Number of events 12
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Coma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Complex partial seizures
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Convulsion
|
2.1%
9/434 • Number of events 9
|
4.1%
9/222 • Number of events 9
|
|
Nervous system disorders
Depressed level of consciousness
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Encephalopathy
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Facial spasm
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.8%
12/434 • Number of events 12
|
3.6%
8/222 • Number of events 8
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
1.4%
6/434 • Number of events 6
|
2.7%
6/222 • Number of events 6
|
|
Nervous system disorders
Headache
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Hemiparesis
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Nervous system disorders
Hydrocephalus
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Intracranial haematoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Intracranial pressure increased
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Nervous system disorders
Ischaemic stroke
|
1.4%
6/434 • Number of events 7
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Lethargy
|
0.00%
0/434
|
1.4%
3/222 • Number of events 3
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Neurological symptom
|
2.8%
12/434 • Number of events 13
|
1.8%
4/222 • Number of events 4
|
|
Nervous system disorders
Presyncope
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Status epilepticus
|
0.23%
1/434 • Number of events 2
|
0.00%
0/222
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.4%
6/434 • Number of events 6
|
0.00%
0/222
|
|
Nervous system disorders
Syncope
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Thalamic infarction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Transient ischaemic attack
|
0.69%
3/434 • Number of events 3
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Tremor
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Aggression
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Agitation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.23%
1/434 • Number of events 2
|
0.00%
0/222
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
Psychiatric disorders
Emotional disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Mental status changes
|
1.4%
6/434 • Number of events 7
|
0.90%
2/222 • Number of events 2
|
|
Psychiatric disorders
Suicide attempt
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Haematuria
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Renal failure
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Renal failure chronic
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
5/434 • Number of events 5
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.4%
6/434 • Number of events 6
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.92%
4/434 • Number of events 4
|
3.6%
8/222 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.2%
5/434 • Number of events 5
|
1.8%
4/222 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.1%
18/434 • Number of events 18
|
2.3%
5/222 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 3
|
|
Surgical and medical procedures
Cholecystectomy
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Craniectomy
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Cranioplasty
|
2.1%
9/434 • Number of events 9
|
1.4%
3/222 • Number of events 3
|
|
Surgical and medical procedures
Intubation
|
0.00%
0/434
|
0.45%
1/222 • Number of events 2
|
|
Surgical and medical procedures
Medical device implantation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Surgery
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Surgical and medical procedures
Tracheostomy
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Arterial restenosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Arterial thrombosis limb
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
7/434 • Number of events 7
|
0.90%
2/222 • Number of events 2
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Haemodynamic instability
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Haemorrhage
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Vascular disorders
Hypertension
|
0.92%
4/434 • Number of events 4
|
0.90%
2/222 • Number of events 2
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.4%
6/434 • Number of events 6
|
2.7%
6/222 • Number of events 6
|
|
Vascular disorders
Iliac artery thrombosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Peripheral embolism
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Peripheral ischaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Peripheral vascular disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Shock
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
Other adverse events
| Measure |
Endovascular
n=434 participants at risk
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.
|
IV Only
n=222 participants at risk
Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.0%
39/434 • Number of events 41
|
7.2%
16/222 • Number of events 17
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.6%
7/434 • Number of events 7
|
2.3%
5/222 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
5/434 • Number of events 5
|
2.3%
5/222 • Number of events 5
|
|
Cardiac disorders
Acute myocardial infarction
|
0.92%
4/434 • Number of events 4
|
0.00%
0/222
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Aortic valve disease
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Aortic valve stenosis
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Atrial fibrillation
|
8.5%
37/434 • Number of events 41
|
9.5%
21/222 • Number of events 22
|
|
Cardiac disorders
Atrial flutter
|
0.69%
3/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Bradycardia
|
4.1%
18/434 • Number of events 19
|
4.1%
9/222 • Number of events 9
|
|
Cardiac disorders
Bundle branch block right
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Cardiac disorders
Cardiac failure acute
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Cardiac failure congestive
|
3.7%
16/434 • Number of events 17
|
3.2%
7/222 • Number of events 8
|
|
Cardiac disorders
Cardiac valve disease
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Cardiac disorders
Cardiac valve vegetation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Cardiogenic shock
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Cardiomegaly
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Cardiac disorders
Cardiomyopathy
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Cardiac disorders
Cardiovascular disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Diastolic dysfunction
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Intracardiac thrombus
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Mitral valve stenosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Myocardial infarction
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Nodal arrhythmia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Palpitations
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Sick sinus syndrome
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Sinus arrhythmia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
0.46%
2/434 • Number of events 2
|
3.2%
7/222 • Number of events 7
|
|
Cardiac disorders
Sinus tachycardia
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
3.5%
15/434 • Number of events 16
|
4.1%
9/222 • Number of events 9
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
1.4%
6/434 • Number of events 6
|
1.4%
3/222 • Number of events 3
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.69%
3/434 • Number of events 3
|
0.90%
2/222 • Number of events 2
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Congenital, familial and genetic disorders
Homocystinaemia
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Endocrine disorders
Diabetes insipidus
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Endocrine disorders
Hypothyroidism
|
0.23%
1/434 • Number of events 1
|
1.4%
3/222 • Number of events 3
|
|
Eye disorders
Conjunctival haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Eye disorders
Conjunctivitis
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Eye disorders
Eye disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Eye disorders
Eye pain
|
0.23%
1/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Eye disorders
Eye swelling
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Eye disorders
Eyelid ptosis
|
0.46%
2/434 • Number of events 3
|
0.00%
0/222
|
|
Eye disorders
Ocular hyperaemia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Eye disorders
Pupil fixed
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Eye disorders
Scleral oedema
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Eye disorders
Ulcerative keratitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Eye disorders
Vision blurred
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Abdominal distension
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
8/434 • Number of events 8
|
0.90%
2/222 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Constipation
|
9.4%
41/434 • Number of events 43
|
11.7%
26/222 • Number of events 27
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
21/434 • Number of events 21
|
4.1%
9/222 • Number of events 9
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
8/434 • Number of events 8
|
1.8%
4/222 • Number of events 4
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
14/434 • Number of events 14
|
1.4%
3/222 • Number of events 3
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Gastrointestinal disorders
Flatulence
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
5/434 • Number of events 5
|
1.4%
3/222 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
6/434 • Number of events 6
|
0.90%
2/222 • Number of events 2
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.69%
3/434 • Number of events 3
|
2.7%
6/222 • Number of events 6
|
|
Gastrointestinal disorders
Gingivitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Haematemesis
|
0.92%
4/434 • Number of events 4
|
0.90%
2/222 • Number of events 2
|
|
Gastrointestinal disorders
Haematochezia
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
5/434 • Number of events 5
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Melaena
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
9.9%
43/434 • Number of events 45
|
7.7%
17/222 • Number of events 18
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Gastrointestinal disorders
Swollen tongue
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Toothache
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
39/434 • Number of events 40
|
9.5%
21/222 • Number of events 22
|
|
General disorders
Adverse drug reaction
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
General disorders
Asthenia
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
General disorders
Catheter site bruise
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Catheter site haemorrhage
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
General disorders
Catheter site related reaction
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
General disorders
Chest pain
|
3.9%
17/434 • Number of events 17
|
4.1%
9/222 • Number of events 10
|
|
General disorders
Chills
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Discomfort
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Extravasation
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Face oedema
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
General disorders
Facial pain
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Fatigue
|
2.3%
10/434 • Number of events 10
|
0.90%
2/222 • Number of events 2
|
|
General disorders
Feeling cold
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Generalised oedema
|
0.92%
4/434 • Number of events 4
|
1.4%
3/222 • Number of events 3
|
|
General disorders
Hyperthermia
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
General disorders
Implant site pain
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Infusion site erythema
|
0.23%
1/434 • Number of events 2
|
0.00%
0/222
|
|
General disorders
Infusion site haemorrhage
|
0.92%
4/434 • Number of events 4
|
1.4%
3/222 • Number of events 3
|
|
General disorders
Infusion site oedema
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Injection site extravasation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Local swelling
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Malaise
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Mass
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Non-cardiac chest pain
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Oedema peripheral
|
5.3%
23/434 • Number of events 29
|
5.9%
13/222 • Number of events 15
|
|
General disorders
Pain
|
6.9%
30/434 • Number of events 32
|
6.3%
14/222 • Number of events 16
|
|
General disorders
Pitting oedema
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Puncture site haemorrhage
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
General disorders
Pyrexia
|
8.1%
35/434 • Number of events 36
|
14.0%
31/222 • Number of events 32
|
|
General disorders
Swelling
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Vessel puncture site bruise
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
3.5%
15/434 • Number of events 15
|
0.45%
1/222 • Number of events 1
|
|
General disorders
Vessel puncture site haemorrhage
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Immune system disorders
Drug hypersensitivity
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Immune system disorders
Hypersensitivity
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Abdominal wall abscess
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Abscess limb
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Infections and infestations
Bronchitis
|
0.92%
4/434 • Number of events 4
|
1.8%
4/222 • Number of events 4
|
|
Infections and infestations
Bronchitis acute
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Candidiasis
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Chest wall abscess
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Clostridial infection
|
0.92%
4/434 • Number of events 4
|
1.4%
3/222 • Number of events 3
|
|
Infections and infestations
Clostridium difficile colitis
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Eye infection
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Infections and infestations
Fungal infection
|
1.2%
5/434 • Number of events 5
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Fungal skin infection
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Herpes simplex
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Herpes zoster
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Infections and infestations
Infection
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Infusion site infection
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Nail infection
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Nasopharyngitis
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Oral candidiasis
|
3.7%
16/434 • Number of events 16
|
2.7%
6/222 • Number of events 6
|
|
Infections and infestations
Oral fungal infection
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Orchitis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
8.3%
36/434 • Number of events 39
|
3.6%
8/222 • Number of events 8
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Pneumonia streptococcal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
6/434 • Number of events 6
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
1.6%
7/434 • Number of events 7
|
0.90%
2/222 • Number of events 2
|
|
Infections and infestations
Skin infection
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/434
|
1.4%
3/222 • Number of events 3
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Tracheobronchitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Upper respiratory tract infection
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Infections and infestations
Urinary tract infection
|
20.7%
90/434 • Number of events 104
|
20.7%
46/222 • Number of events 51
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Urosepsis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Vaginal candidiasis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Vaginal infection
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Wound infection
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Wound infection bacterial
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Conjunctival abrasion
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Contusion
|
6.0%
26/434 • Number of events 30
|
4.1%
9/222 • Number of events 12
|
|
Injury, poisoning and procedural complications
Device lead damage
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Difficult to wean from ventilator
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.69%
3/434 • Number of events 4
|
0.90%
2/222 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
13/434 • Number of events 15
|
8.1%
18/222 • Number of events 18
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 2
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site complication
|
1.2%
5/434 • Number of events 5
|
0.90%
2/222 • Number of events 3
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intubation complication
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medication error
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.8%
8/434 • Number of events 9
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Wound
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrong technique in drug usage process
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.92%
4/434 • Number of events 4
|
0.00%
0/222
|
|
Investigations
Bacteria stool identified
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood albumin abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood culture positive
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood electrolytes abnormal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood magnesium decreased
|
1.8%
8/434 • Number of events 8
|
1.4%
3/222 • Number of events 3
|
|
Investigations
Blood phosphorus decreased
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Investigations
Blood potassium decreased
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Investigations
Blood test abnormal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood urea abnormal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Blood urea increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Body temperature increased
|
1.4%
6/434 • Number of events 6
|
0.90%
2/222 • Number of events 3
|
|
Investigations
Breath sounds abnormal
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 3
|
|
Investigations
C-reactive protein increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Cardiac enzymes increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Computerised tomogram abnormal
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Culture urine positive
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Drug level fluctuating
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Electrocardiogram ST segment depression
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Electroencephalogram abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Free prostate-specific antigen increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Full blood count abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Haematology test abnormal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Haemoglobin
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Haemoglobin abnormal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Haemoglobin decreased
|
1.8%
8/434 • Number of events 9
|
0.90%
2/222 • Number of events 2
|
|
Investigations
Heart rate decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Inspiratory capacity decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
International normalised ratio increased
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Myoglobin blood increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
NIH stroke scale score increased
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Investigations
Neurological examination abnormal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Oxygen saturation decreased
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Investigations
Platelet count decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Platelet count increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Prothrombin time prolonged
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Pulmonary function test decreased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Red blood cell count decreased
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Residual urine volume
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Scan with contrast abnormal
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Troponin I increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Troponin increased
|
2.3%
10/434 • Number of events 10
|
1.4%
3/222 • Number of events 3
|
|
Investigations
Urine output decreased
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Investigations
Urine output increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Venous pressure jugular increased
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Weight decreased
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Investigations
Weight increased
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Investigations
White blood cell count increased
|
3.0%
13/434 • Number of events 13
|
1.4%
3/222 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
5/434 • Number of events 5
|
1.4%
3/222 • Number of events 3
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.69%
3/434 • Number of events 3
|
0.90%
2/222 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
5.3%
23/434 • Number of events 25
|
3.2%
7/222 • Number of events 7
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
Metabolism and nutrition disorders
Gout
|
0.69%
3/434 • Number of events 3
|
1.4%
3/222 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
31/434 • Number of events 31
|
5.0%
11/222 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyperhomocysteinaemia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.2%
5/434 • Number of events 5
|
4.5%
10/222 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.69%
3/434 • Number of events 3
|
1.4%
3/222 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.8%
8/434 • Number of events 8
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
5/434 • Number of events 5
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.2%
40/434 • Number of events 40
|
8.1%
18/222 • Number of events 20
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
14/434 • Number of events 14
|
3.2%
7/222 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.69%
3/434 • Number of events 3
|
0.90%
2/222 • Number of events 2
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.2%
5/434 • Number of events 5
|
2.3%
5/222 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
22/434 • Number of events 25
|
3.2%
7/222 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
23/434 • Number of events 24
|
5.9%
13/222 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.92%
4/434 • Number of events 4
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.92%
4/434 • Number of events 4
|
0.90%
2/222 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.23%
1/434 • Number of events 1
|
2.3%
5/222 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.46%
2/434 • Number of events 2
|
1.4%
3/222 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.1%
18/434 • Number of events 18
|
3.6%
8/222 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
7/434 • Number of events 7
|
2.3%
5/222 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
28/434 • Number of events 31
|
5.4%
12/222 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.92%
4/434 • Number of events 4
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondromatosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Nervous system disorders
Amnesia
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Nervous system disorders
Aphasia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Balance disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Brain oedema
|
2.3%
10/434 • Number of events 10
|
6.8%
15/222 • Number of events 16
|
|
Nervous system disorders
Carotid arterial embolus
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Carotid artery dissection
|
1.6%
7/434 • Number of events 8
|
0.00%
0/222
|
|
Nervous system disorders
Carotid artery stenosis
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Cerebral artery embolism
|
1.2%
5/434 • Number of events 5
|
0.00%
0/222
|
|
Nervous system disorders
Cerebral haemorrhage
|
6.0%
26/434 • Number of events 26
|
3.2%
7/222 • Number of events 7
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 2
|
|
Nervous system disorders
Cerebrovascular spasm
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Cognitive disorder
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
3.7%
16/434 • Number of events 19
|
2.3%
5/222 • Number of events 5
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Dizziness
|
3.5%
15/434 • Number of events 17
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Nervous system disorders
Dystonia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Encephalomalacia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Encephalopathy
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Facial palsy
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Grand mal convulsion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Haemorrhage intracranial
|
9.9%
43/434 • Number of events 43
|
6.3%
14/222 • Number of events 14
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
8.1%
35/434 • Number of events 35
|
8.1%
18/222 • Number of events 18
|
|
Nervous system disorders
Headache
|
18.4%
80/434 • Number of events 86
|
23.0%
51/222 • Number of events 55
|
|
Nervous system disorders
Hemiparesis
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Hydrocephalus
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.69%
3/434 • Number of events 4
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Intention tremor
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Intracranial aneurysm
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Intracranial haematoma
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Nervous system disorders
Lethargy
|
1.2%
5/434 • Number of events 6
|
2.3%
5/222 • Number of events 5
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Mental impairment
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Muscle spasticity
|
0.69%
3/434 • Number of events 3
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Neurological symptom
|
2.8%
12/434 • Number of events 12
|
2.3%
5/222 • Number of events 5
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
1.2%
5/434 • Number of events 5
|
0.00%
0/222
|
|
Nervous system disorders
Partial seizures
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Putamen haemorrhage
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Restless legs syndrome
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Sciatica
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Sensory loss
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.92%
4/434 • Number of events 4
|
1.8%
4/222 • Number of events 4
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.8%
8/434 • Number of events 8
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.92%
4/434 • Number of events 4
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
6/434 • Number of events 6
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Tremor
|
1.2%
5/434 • Number of events 5
|
0.90%
2/222 • Number of events 2
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Vascular dementia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Acute psychosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Aggression
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Psychiatric disorders
Agitation
|
7.1%
31/434 • Number of events 32
|
8.1%
18/222 • Number of events 19
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
5.5%
24/434 • Number of events 25
|
4.5%
10/222 • Number of events 11
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Catatonia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Confusional state
|
1.4%
6/434 • Number of events 6
|
0.00%
0/222
|
|
Psychiatric disorders
Delirium
|
1.2%
5/434 • Number of events 5
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Delirium tremens
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
Psychiatric disorders
Depression
|
9.9%
43/434 • Number of events 44
|
8.1%
18/222 • Number of events 19
|
|
Psychiatric disorders
Disorientation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Emotional disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Hallucination
|
1.6%
7/434 • Number of events 7
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Hallucination, visual
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Impulsive behaviour
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Insomnia
|
6.0%
26/434 • Number of events 28
|
5.0%
11/222 • Number of events 11
|
|
Psychiatric disorders
Insomnia related to another mental condition
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Mental status changes
|
0.92%
4/434 • Number of events 4
|
2.7%
6/222 • Number of events 7
|
|
Psychiatric disorders
Osmophobia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Panic attack
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Posturing
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Psychotic disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Psychiatric disorders
Restlessness
|
0.69%
3/434 • Number of events 3
|
2.7%
6/222 • Number of events 6
|
|
Psychiatric disorders
Suicidal ideation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Azotaemia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Renal and urinary disorders
Bladder disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Dysuria
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
5.5%
24/434 • Number of events 25
|
5.9%
13/222 • Number of events 13
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Renal and urinary disorders
Incontinence
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Renal and urinary disorders
Oliguria
|
1.4%
6/434 • Number of events 6
|
0.90%
2/222 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Proteinuria
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Renal disorder
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Renal failure
|
0.92%
4/434 • Number of events 4
|
0.90%
2/222 • Number of events 2
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
6/434 • Number of events 6
|
0.45%
1/222 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Renal and urinary disorders
Urethral discharge
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
7/434 • Number of events 7
|
0.90%
2/222 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
3.0%
13/434 • Number of events 13
|
2.7%
6/222 • Number of events 7
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Reproductive system and breast disorders
Breast mass
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.69%
3/434 • Number of events 3
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.6%
7/434 • Number of events 7
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.8%
8/434 • Number of events 8
|
1.8%
4/222 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cheyne-Stokes respiration
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
9/434 • Number of events 9
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
7/434 • Number of events 7
|
3.6%
8/222 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.9%
17/434 • Number of events 18
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
5/434 • Number of events 5
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
7/434 • Number of events 7
|
1.4%
3/222 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/434
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
8/434 • Number of events 8
|
1.8%
4/222 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
3.0%
13/434 • Number of events 16
|
4.5%
10/222 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.92%
4/434 • Number of events 4
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.92%
4/434 • Number of events 4
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.8%
21/434 • Number of events 22
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.2%
5/434 • Number of events 5
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
10/434 • Number of events 10
|
1.4%
3/222 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.8%
8/434 • Number of events 8
|
1.8%
4/222 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.46%
2/434 • Number of events 2
|
0.90%
2/222 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.69%
3/434 • Number of events 3
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.8%
8/434 • Number of events 9
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal oedema
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway resistance syndrome
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord cyst
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.8%
8/434 • Number of events 8
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.2%
5/434 • Number of events 7
|
1.8%
4/222 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.23%
1/434 • Number of events 3
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.4%
6/434 • Number of events 6
|
2.7%
6/222 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
5/434 • Number of events 6
|
0.90%
2/222 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Melanosis
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.9%
17/434 • Number of events 17
|
3.6%
8/222 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.23%
1/434 • Number of events 2
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.4%
6/434 • Number of events 7
|
1.4%
3/222 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.23%
1/434 • Number of events 1
|
1.4%
3/222 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.92%
4/434 • Number of events 4
|
0.45%
1/222 • Number of events 1
|
|
Social circumstances
Drug abuser
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Social circumstances
Inadequate diet
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Atrial septal defect repair
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.23%
1/434 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Cerebral oedema management
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Surgical and medical procedures
Cranioplasty
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Gastrointestinal tube removal
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Gastrostomy tube insertion
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
High frequency ablation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Peripheral nerve decompression
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
|
Surgical and medical procedures
Surgery
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Surgical and medical procedures
Toe amputation
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Accelerated hypertension
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Aortic aneurysm
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Artery dissection
|
0.46%
2/434 • Number of events 2
|
0.00%
0/222
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
11/434 • Number of events 11
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Femoral artery dissection
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Haematoma
|
3.2%
14/434 • Number of events 16
|
2.3%
5/222 • Number of events 6
|
|
Vascular disorders
Haemorrhage
|
1.2%
5/434 • Number of events 5
|
0.00%
0/222
|
|
Vascular disorders
Haemorrhagic infarction
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Hypertension
|
6.9%
30/434 • Number of events 32
|
7.2%
16/222 • Number of events 16
|
|
Vascular disorders
Hypotension
|
7.8%
34/434 • Number of events 34
|
10.4%
23/222 • Number of events 23
|
|
Vascular disorders
Labile blood pressure
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Labile hypertension
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.46%
2/434 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Peripheral ischaemia
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disorder
|
0.23%
1/434 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.69%
3/434 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Vascular rupture
|
0.23%
1/434 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/434
|
0.45%
1/222 • Number of events 1
|
Additional Information
Joseph P. Broderick
University of Cincinnati Academic Health Center
Phone: 513-558-5429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication will be authored prior to 12 mos after publication of the primary results without consent of the Publications Subcommittee. 12 mos after this time an Investigator may publish the results at the Collaborating Institution. No institution involved may be restricted from publishing independently 12 mos from publication of the primary paper. After 12 mo all manuscripts from the study must be submitted to the PI/Publications Subcommittee 45 days prior to any submission.
- Publication restrictions are in place
Restriction type: OTHER