Trial Outcomes & Findings for Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial (NCT NCT00059332)
NCT ID: NCT00059332
Last Updated: 2015-08-21
Results Overview
Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0 No symptoms at all 1. No significant disability despite symptoms; 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; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1700 participants
Primary outcome timeframe
3 months after stroke onset
Results posted on
2015-08-21
Participant Flow
Participant milestones
| Measure |
Normal Saline
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
843
|
857
|
|
Overall Study
COMPLETED
|
840
|
855
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Normal Saline
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
Baseline characteristics by cohort
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
Total
n=1700 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
69 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
69 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Age, Customized
<60 years of age
|
239 participants
n=5 Participants
|
242 participants
n=7 Participants
|
481 participants
n=5 Participants
|
|
Age, Customized
60-75 years of age
|
284 participants
n=5 Participants
|
278 participants
n=7 Participants
|
562 participants
n=5 Participants
|
|
Age, Customized
>75 years of age
|
320 participants
n=5 Participants
|
337 participants
n=7 Participants
|
657 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
367 Participants
n=5 Participants
|
358 Participants
n=7 Participants
|
725 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
476 Participants
n=5 Participants
|
499 Participants
n=7 Participants
|
975 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
206 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
402 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
637 Participants
n=5 Participants
|
661 Participants
n=7 Participants
|
1298 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
113 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
661 Participants
n=5 Participants
|
664 Participants
n=7 Participants
|
1325 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Medical History
Hypertension
|
648 participants
n=5 Participants
|
671 participants
n=7 Participants
|
1319 participants
n=5 Participants
|
|
Medical History
Diabetes
|
188 participants
n=5 Participants
|
189 participants
n=7 Participants
|
377 participants
n=5 Participants
|
|
Medical History
Hyperlipidimia
|
407 participants
n=5 Participants
|
398 participants
n=7 Participants
|
805 participants
n=5 Participants
|
|
Medical History
Atrial fibrillation
|
175 participants
n=5 Participants
|
194 participants
n=7 Participants
|
369 participants
n=5 Participants
|
|
Medical History
Myocardial infarction
|
82 participants
n=5 Participants
|
94 participants
n=7 Participants
|
176 participants
n=5 Participants
|
|
Medical History
Tobacco use
|
158 participants
n=5 Participants
|
139 participants
n=7 Participants
|
297 participants
n=5 Participants
|
|
Medical History
Alcohol use
|
328 participants
n=5 Participants
|
326 participants
n=7 Participants
|
654 participants
n=5 Participants
|
|
Prestroke function - Living at home
|
823 participants
n=5 Participants
|
834 participants
n=7 Participants
|
1657 participants
n=5 Participants
|
|
Los Angeles Motor Scale at hospital arrival
|
3.3 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
National Institute of Health Stroke Scale (NIHSS) at hospital arrival
|
11.2 units on a scale
STANDARD_DEVIATION 9.8 • n=5 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 9.9 • n=7 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Intravenous tissue plasminogen activator (t-PA) in patients with cerebral ischemia
|
205 participants
n=5 Participants
|
242 participants
n=7 Participants
|
447 participants
n=5 Participants
|
|
Final Diagnosis
Cerebral Ischemia
|
613 participants
n=5 Participants
|
632 participants
n=7 Participants
|
1245 participants
n=5 Participants
|
|
Final Diagnosis
Intracranial Hemorrhage
|
192 participants
n=5 Participants
|
195 participants
n=7 Participants
|
387 participants
n=5 Participants
|
|
Final Diagnosis
Cerebrovascular-mimicking condition
|
37 participants
n=5 Participants
|
30 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after stroke onsetModified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0 No symptoms at all 1. No significant disability despite symptoms; 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; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Outcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Modified Rankin Scale
|
2 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 3 monthsMinimal or no disability based on the modified Rankin score
Outcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Modified Rankin Score of 0 or 1
|
311 participants
|
313 participants
|
SECONDARY outcome
Timeframe: 3 monthsFunctional independence based on modified Rankin score
Outcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Modified Rankin Score ≤2
|
445 participants
|
449 participants
|
SECONDARY outcome
Timeframe: 3 monthsThe National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention
Outcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
NIH Stroke Scale
|
3 units on a scale
Interval 0.0 to 42.0
|
3 units on a scale
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: 3 monthsThe Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are: FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)
Outcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Barthel Index
|
95 units on a scale
Interval 20.0 to 100.0
|
90 units on a scale
Interval 30.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 monthsThe Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes. 1. Physical problems 2. Memory and thinking 3. Mood and emotions 4. Communication, reading and understanding 5. Daily activities 6. Mobility at home and in the community 7. Affected hand use 8. Hobbies and activities participation
Outcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Stroke Impact Scale
|
65 units on a scale
Interval 5.4 to 91.7
|
67 units on a scale
Interval 11.7 to 91.7
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Serious Adverse Events
|
422 participants
|
439 participants
|
SECONDARY outcome
Timeframe: 3 monthOutcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Symptomatic Intracranial Hemorrhage
|
28 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Normal Saline
n=843 Participants
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 Participants
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Mortality
|
131 participants
|
132 participants
|
Adverse Events
Normal Saline
Serious events: 422 serious events
Other events: 331 other events
Deaths: 0 deaths
Magnesium Sulfate
Serious events: 439 serious events
Other events: 329 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Saline
n=843 participants at risk
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 participants at risk
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Blood and lymphatic system disorders
Anemia
|
0.95%
8/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
1.4%
12/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Angina pectoris
|
0.59%
5/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Atrial fibrillation
|
4.9%
41/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
5.0%
43/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Bradycardia
|
2.6%
22/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
3.3%
28/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Cardiac arrest
|
2.1%
18/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
2.5%
21/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Cardiac discomfort
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
10/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.82%
7/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.59%
5/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.47%
4/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
10/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
1.5%
13/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Pericarditis
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.47%
4/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.47%
4/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Syncope
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Torsade de pointes
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.36%
3/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.47%
4/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Constipation
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Dysphagia
|
5.2%
44/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
5.3%
45/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
9/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.47%
4/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Ileus
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Parotitis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Gastrointestinal disorders
Vomiting
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
General disorders
Asthenia
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
General disorders
Chest pain
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
General disorders
Fatigue
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
General disorders
Non-cardiac chest pain
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
General disorders
Pelvic mass
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
General disorders
Pyrexia
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Hepatobiliary disorders
Hepatitis
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Hepatobiliary disorders
Jaundice
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Immune system disorders
Anaphylactic reaction
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Immune system disorders
Hypersensitivity
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Device related infection
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Diverticulitis
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Herpes zoster
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Lung abscess
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Pneumonia
|
2.6%
22/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
4.2%
36/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Sepsis
|
1.4%
12/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
2.5%
21/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Septic shock
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
17/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.82%
7/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Urosepsis
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Infections and infestations
Wound infection
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.47%
4/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.36%
3/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maxillofacial sinus neoplasm
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primitive neuroectodermal tumour
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Agitation
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Brain compression
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Brain injury
|
0.36%
3/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Brain oedema
|
2.6%
22/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
1.9%
16/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.47%
4/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Cerebral haemorrhage
|
3.0%
25/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
4.6%
39/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Cerebral infarction
|
4.4%
37/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
3.7%
32/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
11/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.47%
4/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Complicated migraine
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Convulsion
|
0.47%
4/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.82%
7/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Cytotoxic oedema
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
2.3%
19/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
1.5%
13/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.71%
6/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Headache
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Hydrocephalus
|
1.1%
9/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.58%
5/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Ischaemic stroke
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Migraine
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Neurological decompensation
|
12.2%
103/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
12.3%
105/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Paraesthesia
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Sensory disturbance
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Status epilepticus
|
0.36%
3/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.36%
3/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Syncope
|
0.36%
3/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
9/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
2.9%
25/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Psychiatric disorders
Agitation
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Psychiatric disorders
Anxiety
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Psychiatric disorders
Confusional state
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Psychiatric disorders
Depression
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Psychiatric disorders
Psychosomatic disease
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Renal and urinary disorders
Haematuria
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Renal and urinary disorders
Nephritis interstitial
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Renal and urinary disorders
Renal failure
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Renal and urinary disorders
Renal failure acute
|
0.71%
6/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
16/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
4.0%
34/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Renal and urinary disorders
Epistaxis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal disorder
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.36%
3/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.47%
4/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
9/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
1.6%
14/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.82%
7/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.36%
3/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.95%
8/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.58%
5/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.47%
4/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Cranioplasty
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Craniotomy
|
0.59%
5/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Endotracheal intubation
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Haematoma evacuation
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Lung lobectomy
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Medical device implantation
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Transfusion
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Surgical and medical procedures
Ventricular drainage
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Aortic aneurysm
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Carotid artery dissection
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Deep vein thrombosis
|
3.7%
31/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
4.2%
36/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Gangrene
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Haematoma
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Haemorrhage
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Hypertension
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Hypotension
|
3.6%
30/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
6.9%
59/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Malignant hypertension
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Neurogenic shock
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.35%
3/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.24%
2/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.12%
1/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Syncope
|
0.00%
0/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.23%
2/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Vascular disorders
Vasospasm
|
0.12%
1/843 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
0.00%
0/857 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
Other adverse events
| Measure |
Normal Saline
n=843 participants at risk
Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
|
Magnesium Sulfate
n=857 participants at risk
Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
|
|---|---|---|
|
General disorders
Headache
|
19.8%
167/843 • Number of events 173 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
20.8%
178/857 • Number of events 184 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Blood and lymphatic system disorders
Hypokalaemia
|
25.4%
214/843 • Number of events 233 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
23.9%
205/857 • Number of events 217 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
|
Renal and urinary disorders
Urinary tract infection
|
15.8%
133/843 • Number of events 142 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
16.1%
138/857 • Number of events 152 • 3 months after stroke onset
A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.
|
Additional Information
Dr. Jeffrey Saver
UCLA, David Geffen School of Medicine
Phone: 310-794-6379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place