Trial Outcomes & Findings for Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial (NCT NCT01657461)
NCT ID: NCT01657461
Last Updated: 2017-05-18
Results Overview
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 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
NA
Target enrollment
196 participants
Primary outcome timeframe
90 days
Results posted on
2017-05-18
Participant Flow
Participant milestones
| Measure |
IV t-PA With Solitaire™ Revascularization Device
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
IV infusion of tPA
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
98
|
|
Overall Study
COMPLETED
|
88
|
78
|
|
Overall Study
NOT COMPLETED
|
10
|
20
|
Reasons for withdrawal
| Measure |
IV t-PA With Solitaire™ Revascularization Device
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
IV infusion of tPA
|
|---|---|---|
|
Overall Study
Death
|
9
|
12
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Date of birth was not recorded per country regulations.
Baseline characteristics by cohort
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=98 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=96 Participants
IV infusion of tPA
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.99 years
STANDARD_DEVIATION 12.49 • n=98 Participants • Date of birth was not recorded per country regulations.
|
66.32 years
STANDARD_DEVIATION 11.277 • n=95 Participants • Date of birth was not recorded per country regulations.
|
65.64 years
STANDARD_DEVIATION 11.89 • n=193 Participants • Date of birth was not recorded per country regulations.
|
|
Sex: Female, Male
Female
|
44 Participants
n=98 Participants
|
51 Participants
n=96 Participants
|
95 Participants
n=194 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=98 Participants
|
45 Participants
n=96 Participants
|
99 Participants
n=194 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=98 Participants
|
66 participants
n=96 Participants
|
131 participants
n=194 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=98 Participants
|
1 participants
n=96 Participants
|
2 participants
n=194 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=98 Participants
|
1 participants
n=96 Participants
|
2 participants
n=194 Participants
|
|
Region of Enrollment
France
|
8 participants
n=98 Participants
|
4 participants
n=96 Participants
|
12 participants
n=194 Participants
|
|
Region of Enrollment
Germany
|
20 participants
n=98 Participants
|
22 participants
n=96 Participants
|
42 participants
n=194 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=98 Participants
|
1 participants
n=96 Participants
|
2 participants
n=194 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=98 Participants
|
1 participants
n=96 Participants
|
3 participants
n=194 Participants
|
|
NIHSS
|
16.69 Scores on a scale
STANDARD_DEVIATION 4.68 • n=98 Participants • Two subjects in the IV t-PA arm did not have baseline NIHSS recorded
|
16.49 Scores on a scale
STANDARD_DEVIATION 4.60 • n=94 Participants • Two subjects in the IV t-PA arm did not have baseline NIHSS recorded
|
16.59 Scores on a scale
STANDARD_DEVIATION 4.63 • n=192 Participants • Two subjects in the IV t-PA arm did not have baseline NIHSS recorded
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 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 |
IV t-PA With Solitaire™ Revascularization Device
n=98 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=93 Participants
IV infusion of tPA
|
|---|---|---|
|
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
mRS 1
|
25 Participants
|
10 Participants
|
|
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
mRS 2
|
17 Participants
|
15 Participants
|
|
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
mRS 3
|
12 Participants
|
16 Participants
|
|
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
mRS 4
|
15 Participants
|
20 Participants
|
|
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
mRS 0
|
17 Participants
|
8 Participants
|
|
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).
mRS 5/6
|
12 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: One subject in the IV t-PA arm withdrew and requested all data be removed.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=98 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=97 Participants
IV infusion of tPA
|
|---|---|---|
|
Death Due to Any Cause at 90 Days
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=98 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=93 Participants
IV infusion of tPA
|
|---|---|---|
|
Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days
|
59 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline to 27±6 hours post randomizationPopulation: Final assessment not available for all subjects.
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=97 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=92 Participants
IV infusion of tPA
|
|---|---|---|
|
Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization
|
-8.5 units on a scale
Standard Deviation 7.1
|
-3.9 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 27±6 hours post randomizationPopulation: Final assessment not available for all subjects.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=97 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=94 Participants
IV infusion of tPA
|
|---|---|---|
|
Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization
|
60.2 cc
Standard Deviation 86
|
65.9 cc
Standard Deviation 73.5
|
SECONDARY outcome
Timeframe: 27±6 hours post randomizationPopulation: Final assessment not available for all subjects.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=64 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=52 Participants
IV infusion of tPA
|
|---|---|---|
|
Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization
|
81 Reperfusion ratio
Standard Deviation 67.3
|
61.9 Reperfusion ratio
Standard Deviation 53
|
SECONDARY outcome
Timeframe: Post procedurePopulation: Final assessment not available for all subjects.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=83 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
IV infusion of tPA
|
|---|---|---|
|
Arterial Revascularization Measured by TICI 2b or 3 Following Device Use
|
73 Participants
|
—
|
SECONDARY outcome
Timeframe: 27±6 hours post randomizationPopulation: Final assessment not available for all subjects.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=58 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
IV infusion of tPA
|
|---|---|---|
|
Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage
|
0.46 Correlation
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 90 daysPopulation: One subject in the IV t-PA arm withdrew and requested all data be removed.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=98 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=97 Participants
IV infusion of tPA
|
|---|---|---|
|
Incidence of All Serious Adverse Events (SAEs)
|
35 Participants
|
30 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 27±6 hours post randomizationPopulation: One subject in the IV t-PA arm withdrew and requested all data be removed.
Outcome measures
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=98 Participants
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=97 Participants
IV infusion of tPA
|
|---|---|---|
|
Incidence of sICH at 27±6 Hours Post Randomization
|
0 Participants
|
3 Participants
|
Adverse Events
IV t-PA With Solitaire™ Revascularization Device
Serious events: 35 serious events
Other events: 91 other events
Deaths: 0 deaths
IV t-PA
Serious events: 30 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=98 participants at risk
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=97 participants at risk
IV infusion of tPA
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
3/98 • Number of events 3 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Intracardiac thrombus
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Sick sinus syndrome
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/98 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Ileus
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Endocarditis
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Escherichia sepsis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Parotitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Sepsis
|
2.0%
2/98 • Number of events 2 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Brain oedema
|
3.1%
3/98 • Number of events 3 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Convulsion
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/98 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Intracranial aneurysm
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Intracranial pressure increased
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Intraventricular haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
2/98 • Number of events 3 • 90 days
|
6.2%
6/97 • Number of events 6 • 90 days
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Stroke in evolution
|
7.1%
7/98 • Number of events 7 • 90 days
|
8.2%
8/97 • Number of events 8 • 90 days
|
|
Nervous system disorders
Vasculitis cerebral
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Mental status changes
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Haematuria
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Renal failure acute
|
3.1%
3/98 • Number of events 3 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/98 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
2/98 • Number of events 2 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Vascular disorders
Arterial rupture
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Vascular disorders
Embolism arterial
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/98 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Vascular occlusion
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
Other adverse events
| Measure |
IV t-PA With Solitaire™ Revascularization Device
n=98 participants at risk
Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
|
IV t-PA
n=97 participants at risk
IV infusion of tPA
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.2%
8/98 • Number of events 8 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.1%
6/98 • Number of events 6 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Atrial fibrillation
|
5.1%
5/98 • Number of events 5 • 90 days
|
5.2%
5/97 • Number of events 5 • 90 days
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Atrial thrombosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Bradycardia
|
4.1%
4/98 • Number of events 4 • 90 days
|
7.2%
7/97 • Number of events 8 • 90 days
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Cardiac failure
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Intracardiac thrombus
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Cardiac disorders
Palpitations
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Sick sinus syndrome
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Sinus arrest
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Cardiac disorders
Tachycardia
|
8.2%
8/98 • Number of events 8 • 90 days
|
9.3%
9/97 • Number of events 9 • 90 days
|
|
Cardiac disorders
Ventricular tachycardia
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Endocrine disorders
Hypothyroidism
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Eye disorders
Conjunctival haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Eye disorders
Dry eye
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Eye disorders
Optic neuropathy
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Eye disorders
Photopsia
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Eye disorders
Visual impairment
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Constipation
|
17.3%
17/98 • Number of events 18 • 90 days
|
15.5%
15/97 • Number of events 16 • 90 days
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/98 • Number of events 2 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Gastrointestinal disorders
Dyspepsia
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Dysphagia
|
8.2%
8/98 • Number of events 8 • 90 days
|
8.2%
8/97 • Number of events 8 • 90 days
|
|
Gastrointestinal disorders
Faecal incontinence
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Haematemesis
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Ileus
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Nausea
|
9.2%
9/98 • Number of events 9 • 90 days
|
6.2%
6/97 • Number of events 6 • 90 days
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Oral pain
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Gastrointestinal disorders
Swollen tongue
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
7/98 • Number of events 7 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
General disorders
Application site pruritus
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Catheter site haematoma
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Catheter site haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Catheter site induration
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Catheter site inflammation
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Chest pain
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
General disorders
Cyst
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
General disorders
Discomfort
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Extravasation
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Fatigue
|
3.1%
3/98 • Number of events 4 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Impaired healing
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Influenza like illness
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
General disorders
Local swelling
|
2.0%
2/98 • Number of events 2 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/98 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
General disorders
Pain
|
5.1%
5/98 • Number of events 5 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
General disorders
Polyp
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
General disorders
Pyrexia
|
9.2%
9/98 • Number of events 9 • 90 days
|
7.2%
7/97 • Number of events 7 • 90 days
|
|
General disorders
Systemic inflammatory response syndrome
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
General disorders
Temperature intolerance
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Hepatobiliary disorders
Hepatic cyst
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Immune system disorders
Drug hypersensitivity
|
2.0%
2/98 • Number of events 2 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Immune system disorders
Immune system disorder
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Acute sinusitis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Candida infection
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Infections and infestations
Cellulitis
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Conjunctivitis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Cystitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Endocarditis
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Epididymitis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Escherichia sepsis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Fungal infection
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Fungal skin infection
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Oral candidiasis
|
3.1%
3/98 • Number of events 3 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Infections and infestations
Parotitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Pneumonia
|
13.3%
13/98 • Number of events 14 • 90 days
|
8.2%
8/97 • Number of events 8 • 90 days
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Sepsis
|
2.0%
2/98 • Number of events 2 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Infections and infestations
Sinusitis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Skin candida
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Infections and infestations
Urinary tract infection
|
19.4%
19/98 • Number of events 21 • 90 days
|
29.9%
29/97 • Number of events 33 • 90 days
|
|
Infections and infestations
Wound infection
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
3/98 • Number of events 4 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Injury, poisoning and procedural complications
Tracheal injury
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Investigations
Biopsy salivary gland
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Investigations
Blood creatinine increased
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Investigations
Blood glucose increased
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Investigations
Blood magnesium abnormal
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Investigations
Blood pressure increased
|
9.2%
9/98 • Number of events 10 • 90 days
|
8.2%
8/97 • Number of events 8 • 90 days
|
|
Investigations
Blood urea increased
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Investigations
Transaminases increased
|
2.0%
2/98 • Number of events 2 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Investigations
Troponin increased
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Investigations
Urine output decreased
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Investigations
Weight decreased
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/98 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
4.1%
4/98 • Number of events 4 • 90 days
|
7.2%
7/97 • Number of events 7 • 90 days
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
Gout
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.0%
1/98 • Number of events 1 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
7/98 • Number of events 7 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/98 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
3/98 • Number of events 3 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.4%
18/98 • Number of events 18 • 90 days
|
7.2%
7/97 • Number of events 7 • 90 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.1%
5/98 • Number of events 5 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.1%
3/98 • Number of events 3 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.0%
1/98 • Number of events 1 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/98 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
3/98 • Number of events 4 • 90 days
|
5.2%
5/97 • Number of events 6 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
3/98 • Number of events 3 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/98 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
1/98 • Number of events 1 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
4/98 • Number of events 4 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Amnesia
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Brain oedema
|
3.1%
3/98 • Number of events 3 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Nervous system disorders
Carotid artery dissection
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Cerebral artery embolism
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Nervous system disorders
Cerebral vasoconstriction
|
12.2%
12/98 • Number of events 12 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Complex regional pain syndrome
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Nervous system disorders
Convulsion
|
1.0%
1/98 • Number of events 1 • 90 days
|
6.2%
6/97 • Number of events 6 • 90 days
|
|
Nervous system disorders
Dizziness
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
32.7%
32/98 • Number of events 33 • 90 days
|
40.2%
39/97 • Number of events 40 • 90 days
|
|
Nervous system disorders
Headache
|
16.3%
16/98 • Number of events 17 • 90 days
|
16.5%
16/97 • Number of events 16 • 90 days
|
|
Nervous system disorders
Hemianopia
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Horner's syndrome
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Hypertonia
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Intracranial aneurysm
|
2.0%
2/98 • Number of events 2 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Intracranial pressure increased
|
2.0%
2/98 • Number of events 2 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Nervous system disorders
Intraventricular haemorrhage
|
4.1%
4/98 • Number of events 4 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Nervous system disorders
Ischaemic stroke
|
3.1%
3/98 • Number of events 4 • 90 days
|
9.3%
9/97 • Number of events 9 • 90 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Migraine
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Muscle spasticity
|
2.0%
2/98 • Number of events 2 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Nervous system disorders
Neuralgia
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Presyncope
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Somnolence
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Stroke in evolution
|
8.2%
8/98 • Number of events 8 • 90 days
|
8.2%
8/97 • Number of events 8 • 90 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/98 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/98 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Nervous system disorders
Vasculitis cerebral
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Acute psychosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Psychiatric disorders
Agitation
|
6.1%
6/98 • Number of events 6 • 90 days
|
8.2%
8/97 • Number of events 8 • 90 days
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Psychiatric disorders
Anxiety
|
2.0%
2/98 • Number of events 3 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Depressed mood
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Psychiatric disorders
Depression
|
15.3%
15/98 • Number of events 15 • 90 days
|
15.5%
15/97 • Number of events 15 • 90 days
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Insomnia
|
9.2%
9/98 • Number of events 9 • 90 days
|
5.2%
5/97 • Number of events 5 • 90 days
|
|
Psychiatric disorders
Mental status changes
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Restlessness
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Psychiatric disorders
Stress
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Haematuria
|
2.0%
2/98 • Number of events 2 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Renal failure acute
|
5.1%
5/98 • Number of events 5 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Renal mass
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Renal and urinary disorders
Urinary retention
|
9.2%
9/98 • Number of events 9 • 90 days
|
0.00%
0/97 • 90 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
2.0%
2/98 • Number of events 2 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.1%
3/98 • Number of events 3 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.0%
2/98 • Number of events 2 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.1%
4/98 • Number of events 4 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
7.1%
7/98 • Number of events 7 • 90 days
|
7.2%
7/97 • Number of events 7 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.1%
4/98 • Number of events 4 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.0%
1/98 • Number of events 1 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.1%
4/98 • Number of events 4 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.0%
1/98 • Number of events 1 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.1%
6/98 • Number of events 6 • 90 days
|
0.00%
0/97 • 90 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
1/98 • Number of events 1 • 90 days
|
3.1%
3/97 • Number of events 3 • 90 days
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
1/98 • Number of events 1 • 90 days
|
2.1%
2/97 • Number of events 2 • 90 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Surgical and medical procedures
Gastrostomy tube removal
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Arterial rupture
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Deep vein thrombosis
|
8.2%
8/98 • Number of events 8 • 90 days
|
7.2%
7/97 • Number of events 7 • 90 days
|
|
Vascular disorders
Embolism arterial
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Haematoma
|
2.0%
2/98 • Number of events 2 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Hypertension
|
5.1%
5/98 • Number of events 5 • 90 days
|
4.1%
4/97 • Number of events 4 • 90 days
|
|
Vascular disorders
Hypotension
|
6.1%
6/98 • Number of events 6 • 90 days
|
6.2%
6/97 • Number of events 6 • 90 days
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/98 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Phlebitis superficial
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Thrombophlebitis
|
3.1%
3/98 • Number of events 3 • 90 days
|
1.0%
1/97 • Number of events 1 • 90 days
|
|
Vascular disorders
Thrombosis
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Vascular occlusion
|
1.0%
1/98 • Number of events 1 • 90 days
|
0.00%
0/97 • 90 days
|
|
Vascular disorders
Vasospasm
|
3.1%
3/98 • Number of events 3 • 90 days
|
0.00%
0/97 • 90 days
|
Additional Information
Manish Gupta, Sr. Director of Medical Affairs
Medtronic
Phone: 949 297 5494
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Physician shall not make any publication without providing Sponsor 30 days notice.If Sponsor determines that the proposed publication contains confidential information, Sponsor may require the delay of publication for a period of time not to exceed 90 days and may require that any confidential information be removed from the publication. Sponsor may also require Physician to delay publication until any factual errors or inaccuracies in the publication are corrected.
- Publication restrictions are in place
Restriction type: OTHER