Interventional Management of Stroke (IMS) III Trial (IMSIII)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00359424 |
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Recruitment Status
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Terminated
(NINDS/NIH-DSMB recommended halting trial due to futility, no safety concerns.)
First Posted
: August 2, 2006
Results First Posted
: December 13, 2013
Last Update Posted
: December 13, 2013
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Sponsor:
Joseph Broderick
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Medical University of South Carolina
University of Calgary
Information provided by (Responsible Party):
Joseph Broderick, University of Cincinnati
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition: |
Stroke |
| Interventions: |
Drug: IV rt-PA alone Other: endovascular therapy |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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A total of 656 participants underwent randomization
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Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 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. |
Participant Flow: Overall Study
| Endovascular Therapy | IV Rt-PA Alone | |
|---|---|---|
| STARTED | 434 | 222 |
| 90 Day Follow up | 343 | 172 |
| 180 Day Follow up | 325 | 167 |
| 270 Day Follow up | 313 | 159 |
| COMPLETED | 304 | 155 |
| NOT COMPLETED | 130 | 67 |
| Death | 99 | 58 |
| Lost to Follow-up | 19 | 7 |
| Withdrawal by Subject | 10 | 2 |
| follow up not conducted | 2 | 0 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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| A sample of 900 was calculated to provide an effect size of 10 percentage points assuming that 40% of the patients had a good outcome in the IV t-PA group, as noted in patients in the NINDS rt-PA Stroke Study who had age and baseline stroke severity similar to the eligibility criteria for the IMS3 trial. The trial was halted at 656 subjects. |
Reporting Groups
| Description | |
|---|---|
| Endovascular Therapy | 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 | Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour. |
| Total | Total of all reporting groups |
Baseline Measures
| Endovascular Therapy | IV Rt-PA Alone | Total | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [Units: Participants] |
434 | 222 | 656 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Age [Units: Years] Median (Full Range) |
69 (23 to 89) |
68 (23 to 84) |
69 (23 to 89) |
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Gender [Units: Participants] |
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| Female | 216 | 100 | 316 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Male | 218 | 122 | 340 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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NIHSS Score [1] [Units: Score on a scale] Median (Full Range) |
17 (7 to 40) |
16 (8 to 30) |
17 (7 to 40) |
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Time from stroke onset to initiation of IV rt-PA [1] [Units: Minutes] Mean (Standard Deviation) |
122.4 (33.7) | 121.2 (33.8) | 122.0 (33.7) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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NIHSS Score Strata [Units: Participants] |
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| NIHSS Score <20 | 302 | 150 | 452 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| NIHSS Score > = 20 | 132 | 72 | 204 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. [ Time Frame: at 90 days post randomization ] |
| 2. Primary: | Death Due to Any Cause [ Time Frame: within 90 days post randomization ] |
| 3. Primary: | Symptomatic Intracranial Hemorrhage [ Time Frame: within the first 30 hours post IV rt-PA ] |
| 4. Secondary: | Incidence of Parenchymal Type II (PH2) Hematomas [ Time Frame: within 30 hours post IV rt-PA ] |
| 5. Secondary: | Asymptomatic Intracranial Hemorrhage [ Time Frame: within 30 hours post IV rt-PA ] |
| 6. Secondary: | National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater. [ Time Frame: at 24 hours post randomization ] |
| 7. Secondary: | National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater. [ Time Frame: at 90 days post randomization ] |
| 8. Secondary: | Barthel Index (BI) Dichotomized 0-90 Versus 95-100 [ Time Frame: at 90 days post randomization ] |
| 9. Secondary: | Trail Making Test Part A Time [ Time Frame: 90 days post randomization ] |
| 10. Secondary: | Trail Making Test Part B Time [ Time Frame: at 90 days post randomization ] |
| 11. Secondary: | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 [ Time Frame: at 180 days ] |
| 12. Secondary: | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 [ Time Frame: 270 days ] |
| 13. Secondary: | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2 [ Time Frame: 360 days post randomization ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| Endovascular | 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 | Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour. |
Serious Adverse Events
| Endovascular | IV Only | |
|---|---|---|
| Total, Serious Adverse Events | ||
| # participants affected / at risk | 256/434 (58.99%) | 126/222 (56.76%) |
| Blood and lymphatic system disorders | ||
| Anaemia † 1 | ||
| # participants affected / at risk | 4/434 (0.92%) | 4/222 (1.80%) |
| # events | 4 | 4 |
| Coagulopathy † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Disseminated intravascular coagulation † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Hypoprothrombinaemia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Iron deficiency anaemia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Thrombocytopenia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Cardiac disorders | ||
| Acute myocardial infarction † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 1/222 (0.45%) |
| # events | 2 | 1 |
| Angina pectoris † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Atrial fibrillation † 1 | ||
| # participants affected / at risk | 7/434 (1.61%) | 5/222 (2.25%) |
| # events | 8 | 5 |
| Atrial flutter † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 0/222 (0.00%) |
| # events | 3 | 0 |
| Atrial tachycardia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Cardiac arrest † 1 | ||
| # participants affected / at risk | 8/434 (1.84%) | 4/222 (1.80%) |
| # events | 9 | 4 |
| Cardiac failure † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Cardiac failure acute † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Cardiac failure congestive † 1 | ||
| # participants affected / at risk | 4/434 (0.92%) | 4/222 (1.80%) |
| # events | 4 | 4 |
| Cardiac valve vegetation † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Cardio-respiratory arrest † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 2/222 (0.90%) |
| # events | 1 | 2 |
| Cardiogenic shock † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Cardiomyopathy † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Cardiopulmonary failure † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Coronary artery disease † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Electromechanical dissociation † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Endocarditis noninfective † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Intracardiac thrombus † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Ischaemic cardiomyopathy † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Mitral valve disease † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Mitral valve stenosis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Myocardial infarction † 1 | ||
| # participants affected / at risk | 4/434 (0.92%) | 0/222 (0.00%) |
| # events | 4 | 0 |
| Pericardial effusion † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Pericardial haemorrhage † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Sick sinus syndrome † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 0/222 (0.00%) |
| # events | 3 | 0 |
| Sinus bradycardia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Tachyarrhythmia † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Tachycardia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Ventricular tachycardia † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 4/222 (1.80%) |
| # events | 2 | 4 |
| Congenital, familial and genetic disorders | ||
| Atrial septal defect † 1 | ||
| # participants affected / at risk | 4/434 (0.92%) | 1/222 (0.45%) |
| # events | 4 | 1 |
| Hereditary cerebral degeneration † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Eye disorders | ||
| Diplopia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Gastrointestinal disorders | ||
| Abdominal pain † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Colitis † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Diarrhoea † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Gastritis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Gastrointestinal haemorrhage † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 3/222 (1.35%) |
| # events | 2 | 3 |
| Gastrooesophageal reflux disease † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Gingival bleeding † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Haematemesis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Haematochezia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Ileus † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Intestinal obstruction † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Pancreatic mass † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Pancreatitis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Peritonitis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Retroperitoneal haematoma † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Retroperitoneal haemorrhage † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Small intestinal obstruction † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Umbilical hernia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| General disorders | ||
| Brain death † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Chest discomfort † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 0/222 (0.00%) |
| # events | 4 | 0 |
| Chest pain † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 1/222 (0.45%) |
| # events | 3 | 1 |
| Extravasation † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| General physical health deterioration † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Multi-organ failure † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Non-cardiac chest pain † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Oedema due to cardiac disease † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Oedema peripheral † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Pyrexia † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Systemic inflammatory response syndrome † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 2/222 (0.90%) |
| # events | 0 | 2 |
| Vessel puncture site haematoma † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Vessel puncture site haemorrhage † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Hepatobiliary disorders | ||
| Cholecystitis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Immune system disorders | ||
| Anaphylactic reaction † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Infections and infestations | ||
| Abdominal wall infection † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Appendicitis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Bacteraemia † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Bacteriuria † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Cellulitis † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Clostridium difficile colitis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Endocarditis † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Endocarditis bacterial † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Gangrene † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Gastroenteritis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 2/222 (0.90%) |
| # events | 1 | 2 |
| Haematoma infection † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Infected skin ulcer † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Infection † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Lobar pneumonia † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Lung infection pseudomonal † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Pneumonia † 1 | ||
| # participants affected / at risk | 16/434 (3.69%) | 8/222 (3.60%) |
| # events | 17 | 8 |
| Pneumonia primary atypical † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Postoperative wound infection † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Pulmonary sepsis † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 2/222 (0.90%) |
| # events | 0 | 2 |
| Respiratory tract infection † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 0/222 (0.00%) |
| # events | 3 | 0 |
| Sepsis † 1 | ||
| # participants affected / at risk | 6/434 (1.38%) | 5/222 (2.25%) |
| # events | 6 | 5 |
| Sepsis syndrome † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Septic shock † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 2/222 (0.90%) |
| # events | 1 | 2 |
| Urinary tract infection † 1 | ||
| # participants affected / at risk | 8/434 (1.84%) | 7/222 (3.15%) |
| # events | 11 | 7 |
| Urosepsis † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 2/222 (0.90%) |
| # events | 2 | 2 |
| Wound infection † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Injury, poisoning and procedural complications | ||
| Aortic injury † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Arterial injury † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Brain herniation † 1 | ||
| # participants affected / at risk | 7/434 (1.61%) | 2/222 (0.90%) |
| # events | 7 | 3 |
| Cardiac procedure complication † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Cervical vertebral fracture † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Concussion † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Difficult to wean from ventilator † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Drug dispensing error † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Fall † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Feeding tube complication † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Femoral neck fracture † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Femur fracture † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Head injury † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Hip fracture † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Injury † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Medication error † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Post procedural haematoma † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Rib fracture † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Stent occlusion † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Subdural haematoma † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Thermal burn † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Thrombosis in device † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Vascular injury † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Vascular procedure complication † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Ventriculoperitoneal shunt malfunction † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Investigations | ||
| Activated partial thromboplastin time prolonged † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Blood culture positive † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Blood glucose increased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Blood magnesium decreased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Blood osmolarity decreased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Blood phosphorus decreased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Computerised tomogram abnormal † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Electrocardiogram ST segment abnormal † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Electroencephalogram abnormal † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Haematocrit decreased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| NIH stroke scale score increased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Oxygen saturation decreased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Troponin increased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Weight decreased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Metabolism and nutrition disorders | ||
| Acid-base balance disorder mixed † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Anorexia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Dehydration † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 1/222 (0.45%) |
| # events | 2 | 1 |
| Diabetes mellitus insulin-dependent † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Failure to thrive † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Hyperglycaemia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Hypokalaemia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Muscular weakness † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Osteoarthritis † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Pain in extremity † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Pain in jaw † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Glioblastoma † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Gliomatosis cerebri † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Lung adenocarcinoma † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Lung neoplasm malignant † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Metastatic neoplasm † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Prostate cancer † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Nervous system disorders | ||
| Aphasia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Brain compression † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Brain oedema † 1 | ||
| # participants affected / at risk | 46/434 (10.60%) | 19/222 (8.56%) |
| # events | 46 | 20 |
| Brain stem infarction † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Carotid artery dissection † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 0/222 (0.00%) |
| # events | 3 | 0 |
| Carotid artery occlusion † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Carotid artery stenosis † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 2/222 (0.90%) |
| # events | 0 | 2 |
| Cerebellar haemorrhage † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Cerebellar infarction † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Cerebral haematoma † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Cerebral haemorrhage † 1 | ||
| # participants affected / at risk | 8/434 (1.84%) | 8/222 (3.60%) |
| # events | 8 | 8 |
| Cerebral infarction † 1 | ||
| # participants affected / at risk | 9/434 (2.07%) | 1/222 (0.45%) |
| # events | 9 | 1 |
| Cerebrovascular accident † 1 | ||
| # participants affected / at risk | 18/434 (4.15%) | 12/222 (5.41%) |
| # events | 19 | 12 |
| Cerebrovascular disorder † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Coma † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Complex partial seizures † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Convulsion † 1 | ||
| # participants affected / at risk | 9/434 (2.07%) | 9/222 (4.05%) |
| # events | 9 | 9 |
| Depressed level of consciousness † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 2/222 (0.90%) |
| # events | 1 | 2 |
| Dizziness † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Encephalopathy † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Facial spasm † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Haemorrhage intracranial † 1 | ||
| # participants affected / at risk | 12/434 (2.76%) | 8/222 (3.60%) |
| # events | 12 | 8 |
| Haemorrhagic cerebral infarction † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Haemorrhagic stroke † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Haemorrhagic transformation stroke † 1 | ||
| # participants affected / at risk | 6/434 (1.38%) | 6/222 (2.70%) |
| # events | 6 | 6 |
| Headache † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Hemiparesis † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Hydrocephalus † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Intracranial haematoma † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Intracranial pressure increased † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Intraventricular haemorrhage † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Ischaemic stroke † 1 | ||
| # participants affected / at risk | 6/434 (1.38%) | 2/222 (0.90%) |
| # events | 7 | 2 |
| Lethargy † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 3/222 (1.35%) |
| # events | 0 | 3 |
| Mental impairment † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Migraine † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Neurological symptom † 1 | ||
| # participants affected / at risk | 12/434 (2.76%) | 4/222 (1.80%) |
| # events | 13 | 4 |
| Presyncope † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Status epilepticus † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Stroke in evolution † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 2/222 (0.90%) |
| # events | 0 | 2 |
| Subarachnoid haemorrhage † 1 | ||
| # participants affected / at risk | 6/434 (1.38%) | 0/222 (0.00%) |
| # events | 6 | 0 |
| Syncope † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Thalamic infarction † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Transient ischaemic attack † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 2/222 (0.90%) |
| # events | 3 | 2 |
| Tremor † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Psychiatric disorders | ||
| Aggression † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Agitation † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Anxiety † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Confusional state † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Delirium tremens † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Depression † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 2/222 (0.90%) |
| # events | 0 | 2 |
| Emotional disorder † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Mental status changes † 1 | ||
| # participants affected / at risk | 6/434 (1.38%) | 2/222 (0.90%) |
| # events | 7 | 2 |
| Suicide attempt † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Renal and urinary disorders | ||
| Haematuria † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Nephrolithiasis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Renal failure † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Renal failure acute † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Renal failure chronic † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Renal mass † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Urinary retention † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Reproductive system and breast disorders | ||
| Pelvic pain † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute pulmonary oedema † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 1/222 (0.45%) |
| # events | 3 | 2 |
| Acute respiratory distress syndrome † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Acute respiratory failure † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 1/222 (0.45%) |
| # events | 3 | 1 |
| Apnoea † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Aspiration † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Atelectasis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 2/222 (0.90%) |
| # events | 1 | 2 |
| Dyspnoea † 1 | ||
| # participants affected / at risk | 3/434 (0.69%) | 1/222 (0.45%) |
| # events | 3 | 1 |
| Epistaxis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Haemoptysis † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Hypoxia † 1 | ||
| # participants affected / at risk | 5/434 (1.15%) | 0/222 (0.00%) |
| # events | 5 | 0 |
| Lung infiltration † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Obstructive airways disorder † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Pneumonia aspiration † 1 | ||
| # participants affected / at risk | 6/434 (1.38%) | 2/222 (0.90%) |
| # events | 6 | 2 |
| Pneumothorax † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Pulmonary embolism † 1 | ||
| # participants affected / at risk | 4/434 (0.92%) | 8/222 (3.60%) |
| # events | 4 | 8 |
| Pulmonary haemorrhage † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Pulmonary oedema † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 1/222 (0.45%) |
| # events | 2 | 1 |
| Respiratory arrest † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 2/222 (0.90%) |
| # events | 1 | 2 |
| Respiratory distress † 1 | ||
| # participants affected / at risk | 5/434 (1.15%) | 4/222 (1.80%) |
| # events | 5 | 4 |
| Respiratory failure † 1 | ||
| # participants affected / at risk | 18/434 (4.15%) | 5/222 (2.25%) |
| # events | 18 | 5 |
| Skin and subcutaneous tissue disorders | ||
| Angioneurotic oedema † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Decubitus ulcer † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Skin ulcer † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Surgical and medical procedures | ||
| Aortic valve replacement † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Cardiac pacemaker insertion † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Cardiac pacemaker replacement † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Carotid endarterectomy † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 2/222 (0.90%) |
| # events | 2 | 3 |
| Cholecystectomy † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Craniectomy † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Cranioplasty † 1 | ||
| # participants affected / at risk | 9/434 (2.07%) | 3/222 (1.35%) |
| # events | 9 | 3 |
| Intubation † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 2 |
| Medical device implantation † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Mitral valve replacement † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Nephrectomy † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Surgery † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Tracheostomy † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 1/222 (0.45%) |
| # events | 2 | 1 |
| Vascular disorders | ||
| Aortic arteriosclerosis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Aortic stenosis † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Arterial restenosis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Arterial thrombosis limb † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Deep vein thrombosis † 1 | ||
| # participants affected / at risk | 7/434 (1.61%) | 2/222 (0.90%) |
| # events | 7 | 2 |
| Femoral artery occlusion † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Haematoma † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 1/222 (0.45%) |
| # events | 1 | 1 |
| Haemodynamic instability † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Haemorrhage † 1 | ||
| # participants affected / at risk | 2/434 (0.46%) | 0/222 (0.00%) |
| # events | 2 | 0 |
| Hypertension † 1 | ||
| # participants affected / at risk | 4/434 (0.92%) | 2/222 (0.90%) |
| # events | 4 | 2 |
| Hypertensive crisis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Hypertensive emergency † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| Hypotension † 1 | ||
| # participants affected / at risk | 6/434 (1.38%) | 6/222 (2.70%) |
| # events | 6 | 6 |
| Iliac artery thrombosis † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Peripheral arterial occlusive disease † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Peripheral artery aneurysm † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Peripheral embolism † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Peripheral ischaemia † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Peripheral vascular disorder † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Shock † 1 | ||
| # participants affected / at risk | 1/434 (0.23%) | 0/222 (0.00%) |
| # events | 1 | 0 |
| Thrombophlebitis † 1 | ||
| # participants affected / at risk | 0/434 (0.00%) | 1/222 (0.45%) |
| # events | 0 | 1 |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA 10.X |
Other Adverse Events
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| The IMS III trial was stopped early because of futility, according to the prespecified rules. A limitation of our trial is that it did not compare the efficacy of the new stent retrievers with that of intravenous t-PA alone. |