Trial Outcomes & Findings for MIND: Artemis in the Removal of Intracerebral Hemorrhage (NCT NCT03342664)
NCT ID: NCT03342664
Last Updated: 2026-01-30
Results Overview
Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
236 participants
Primary outcome timeframe
180 days
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
Artemis + Medical Management (MIS)
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
82
|
|
Overall Study
COMPLETED
|
139
|
70
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MIND: Artemis in the Removal of Intracerebral Hemorrhage
Baseline characteristics by cohort
| Measure |
Artemis + Medical Management (MIS)
n=154 Participants
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 Years
STANDARD_DEVIATION 11.71 • n=35 Participants
|
59.2 Years
STANDARD_DEVIATION 12.33 • n=4328 Participants
|
59.4 Years
STANDARD_DEVIATION 11.90 • n=8687 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=35 Participants
|
32 Participants
n=4328 Participants
|
87 Participants
n=8687 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=35 Participants
|
50 Participants
n=4328 Participants
|
149 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=35 Participants
|
9 Participants
n=4328 Participants
|
31 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=35 Participants
|
61 Participants
n=4328 Participants
|
176 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=35 Participants
|
12 Participants
n=4328 Participants
|
29 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=35 Participants
|
11 Participants
n=4328 Participants
|
23 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
23 Participants
n=35 Participants
|
14 Participants
n=4328 Participants
|
37 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
White
|
102 Participants
n=35 Participants
|
45 Participants
n=4328 Participants
|
147 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
More Than One Race
|
2 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
4 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=35 Participants
|
4 Participants
n=4328 Participants
|
5 Participants
n=8687 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
10 Participants
n=35 Participants
|
7 Participants
n=4328 Participants
|
17 Participants
n=8687 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=35 Participants
|
1 participants
n=4328 Participants
|
3 participants
n=8687 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=35 Participants
|
1 participants
n=4328 Participants
|
1 participants
n=8687 Participants
|
|
Region of Enrollment
United States
|
142 participants
n=35 Participants
|
74 participants
n=4328 Participants
|
216 participants
n=8687 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=35 Participants
|
6 participants
n=4328 Participants
|
16 participants
n=8687 Participants
|
|
BMI
|
30.4 kg/m2
STANDARD_DEVIATION 8.21 • n=35 Participants
|
30.9 kg/m2
STANDARD_DEVIATION 7.28 • n=4328 Participants
|
30.6 kg/m2
STANDARD_DEVIATION 7.88 • n=8687 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: As treated population
Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=154 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
mRS 5
|
14 Participants
|
10 Participants
|
|
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
mRS 6
|
22 Participants
|
14 Participants
|
|
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
Missing mRS value
|
32 Participants
|
20 Participants
|
|
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
mRS 0
|
4 Participants
|
2 Participants
|
|
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
mRS 1
|
5 Participants
|
1 Participants
|
|
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
mRS 2
|
11 Participants
|
8 Participants
|
|
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
mRS 3
|
28 Participants
|
14 Participants
|
|
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
mRS 4
|
38 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: As treated population
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=152 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Rate of Mortality
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 180 daysThe utility-weighted modified Rankin Score (utility-weighted mRS) is a functional outcome measure that quantifies global disability. It is derived from the Ordinal Modified Rankin Scale (mRS), which assesses the degree of disability or functional impairment on a scale. The underlying Modified Rankin Scale categories range from 0 to 6, where: * 0 = No symptoms (best outcome) * 6 = Death (worst outcome) These categorical mRS values are converted to utility weights and the resulting the utility-weighted mRS produces a continuous score ranging from 0.00 to 1.00, where: * 0.00 represents the worst functional outcome (equivalent to severe disability or death) * 1.00 represents the best functional outcome (no symptoms and full independence) Higher scores indicate better functional outcomes. Lower scores indicate worse functional outcomes.
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=154 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)
|
0.41 score on a scale
Standard Deviation 0.314
|
0.38 score on a scale
Standard Deviation 0.318
|
SECONDARY outcome
Timeframe: 365 daysPopulation: As treated population
Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=154 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
mRS 6
|
27 Participants
|
16 Participants
|
|
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
Missing mRS value
|
15 Participants
|
12 Participants
|
|
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
mRS 0
|
4 Participants
|
0 Participants
|
|
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
mRS 1
|
15 Participants
|
6 Participants
|
|
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
mRS 2
|
11 Participants
|
15 Participants
|
|
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
mRS 3
|
31 Participants
|
12 Participants
|
|
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
mRS 4
|
45 Participants
|
14 Participants
|
|
Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)
mRS 5
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 180 and 365 daysPopulation: Numbers analyzed at 180 and 365 are dependent on data available from follow up visits.
The Stroke Impact Scale measures mobility and activities of daily living by assessing ability to perform specific physical tasks using a 5-point scale that ranges from 1 (could not do it at all) to 5 (not difficult at all). The individual scores are converted to a scale of 0 (no recovery) -100 (full recovery) to represent level of recovery, where a higher score means better outcome.
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=154 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Quality of Life Assessed Via Stroke Impact Scale
Mobility (180 days)
|
54.3 score on a scale
Standard Deviation 33.67
|
53.9 score on a scale
Standard Deviation 34.19
|
|
Quality of Life Assessed Via Stroke Impact Scale
Activities of Daily Living (180 days)
|
53.4 score on a scale
Standard Deviation 31.89
|
53.8 score on a scale
Standard Deviation 32.59
|
|
Quality of Life Assessed Via Stroke Impact Scale
Mobility (365 days)
|
55.0 score on a scale
Standard Deviation 32.51
|
58.4 score on a scale
Standard Deviation 33.99
|
|
Quality of Life Assessed Via Stroke Impact Scale
Activities of Daily Living (365 days)
|
55.8 score on a scale
Standard Deviation 30.66
|
56.2 score on a scale
Standard Deviation 33.40
|
SECONDARY outcome
Timeframe: 180 and 365 daysPopulation: The number analyzed at 180 and 365 days are dependent on data available for participants completing visits.
The EQ-5D-5L (EuroQol 5 Dimension 5 Level) is a self assessment on activities of daily living using a visual analog scale (VAS) where current health is rated on a scale of 0 to 100 where 0 is the worst imaginable health and 100 is the best imaginable health.
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=154 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
VAS Quality of Life Assessed Via EQ-5D-5L
EQ-5D-5L-180 days
|
61.6 score on a scale
Standard Deviation 23.41
|
62.4 score on a scale
Standard Deviation 22.82
|
|
VAS Quality of Life Assessed Via EQ-5D-5L
EQ-5D-5L-365 days
|
62.7 score on a scale
Standard Deviation 22.42
|
66.0 score on a scale
Standard Deviation 22.03
|
SECONDARY outcome
Timeframe: Admission to hospital discharge (up to one year)Population: All subjects
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=140 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=77 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Length of Hospital Stay
|
18.8 days
Standard Deviation 17.81
|
20.6 days
Standard Deviation 12.75
|
SECONDARY outcome
Timeframe: # of days from admission (up to one year)Population: All subjects
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=140 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=77 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Length of ICU
|
7.6 days
Standard Deviation 6.51
|
9.2 days
Standard Deviation 8.39
|
SECONDARY outcome
Timeframe: Time from initial sheath placement to final sheath removalPopulation: all subjects (ITT), one participant was randomized to MM but received MIS treatment
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=149 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=1 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Length of Procedure
|
41 minutes
Standard Deviation 29.81
|
34 minutes
Standard Deviation NA
There is only one participant in this group. Standard deviation is not available.
|
SECONDARY outcome
Timeframe: 180 daysPopulation: All subjects
(0 no symptoms - 3 moderate disability)
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=138 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=76 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3
|
57 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: All subjects
mRS 0 no symptoms - 2 slight disability
Outcome measures
| Measure |
Artemis + Medical Management (MIS)
n=138 Participants
Artemis + Medical Management (MIS) Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=76 Participants
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2
|
26 Participants
|
14 Participants
|
Adverse Events
Artemis + Medical Management (MIS)
Serious events: 89 serious events
Other events: 107 other events
Deaths: 27 deaths
Best Medical Management Alone (MM)
Serious events: 60 serious events
Other events: 56 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Artemis + Medical Management (MIS)
n=154 participants at risk
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 participants at risk
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.00%
0/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Bacterial test positive
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Haemoglobin increased
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
International normalised ratio increased
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Liver function test abnormal
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Liver function test increased
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Transaminases increased
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Troponin increased
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
White blood cell count increased
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Alcoholic ketoacidosis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Cerebral salt-wasting syndrome
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal cancer
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Brain midline shift
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Brain oedema
|
2.6%
4/154 • Within 365 days
|
12.2%
10/82 • Within 365 days
|
|
Nervous system disorders
Cerebral haematoma
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
11.0%
17/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Nervous system disorders
Cerebral infarction
|
2.6%
4/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Cytotoxic oedema
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Embolic stroke
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
External hydrocephalus
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Haemorrhage intracranial
|
4.5%
7/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Nervous system disorders
Headache
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Hemiparesis
|
1.3%
2/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Hydrocephalus
|
1.3%
2/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Ischaemic stroke
|
1.9%
3/154 • Within 365 days
|
4.9%
4/82 • Within 365 days
|
|
Nervous system disorders
Lethargy
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Migraine
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Neurological decompensation
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Paroxysmal sympathetic hyperactivity
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Seizure
|
3.9%
6/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Stroke in evolution
|
1.3%
2/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Subdural hygroma
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Syncope
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Agitation
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Delirium
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Mental status changes
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Staring
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Suicidal ideation
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
4/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Renal and urinary disorders
Renal failure
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.6%
4/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.9%
3/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.9%
6/154 • Within 365 days
|
7.3%
6/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.6%
4/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.9%
6/154 • Within 365 days
|
4.9%
4/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract oedema
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Total
|
1.3%
2/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.65%
1/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Surgical and medical procedures
Subdural haematoma evacuation
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Deep vein thrombosis
|
5.8%
9/154 • Within 365 days
|
11.0%
9/82 • Within 365 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Vascular disorders
Hypertensive emergency
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Vascular disorders
Poor venous access
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Blister infected
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Burn infection
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
COVID-19
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Cellulitis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Clostridium difficile colitis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Eye infection bacterial
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Liver abscess
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Infections and infestations
Parotitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Pneumonia
|
2.6%
4/154 • Within 365 days
|
8.5%
7/82 • Within 365 days
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Pulmonary sepsis
|
1.3%
2/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Infections and infestations
Sepsis
|
2.6%
4/154 • Within 365 days
|
11.0%
9/82 • Within 365 days
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Septic shock
|
1.9%
3/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Taeniasis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Tracheitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Urinary tract infection
|
2.6%
4/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Infections and infestations
Urosepsis
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.3%
2/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Pulseless electrical activity
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Sinus node dysfunction
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Eye disorders
Diplopia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Eye disorders
Visual impairment
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.65%
1/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
3/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Ileus
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
General disorders
Chest pain
|
0.65%
1/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
General disorders
Impaired healing
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
General disorders
Pain
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
General disorders
Pyrexia
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Immune system disorders
Anaphylactic reaction
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Anal abscess
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Atrioventricular block
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
Other adverse events
| Measure |
Artemis + Medical Management (MIS)
n=154 participants at risk
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
Artemis + Medical Management: Subject will receive best MM in addition to the MIS procedure with Artemis.
|
Best Medical Management Alone (MM)
n=82 participants at risk
Best medical management alone per standard of care at treating institution
Best Medical Management Alone (MM): Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.9%
6/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Angina pectoris
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
4/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Bradycardia
|
0.65%
1/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Cardiac disorders
Cardiac arrest
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Cardiomegaly
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Diastolic dysfunction
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Myocardial infarction
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Tachyarrhythmia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Cardiac disorders
Tachycardia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Eye disorders
Diplopia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Eye disorders
Visual impairment
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Colitis
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Dysphagia
|
9.7%
15/154 • Within 365 days
|
14.6%
12/82 • Within 365 days
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Ileus
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Oesophagitis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
General disorders
Chest pain
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
General disorders
Impaired healing
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
General disorders
Non-cardiac chest pain
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
General disorders
Pain
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
General disorders
Pyrexia
|
8.4%
13/154 • Within 365 days
|
7.3%
6/82 • Within 365 days
|
|
Hepatobiliary disorders
Total
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Immune system disorders
Total
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Total
|
26.6%
41/154 • Within 365 days
|
24.4%
20/82 • Within 365 days
|
|
Infections and infestations
Anal abscess
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Bacteraemia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Blister infected
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Burn infection
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
COVID-19
|
2.6%
4/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Klebsiella infection
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Liver abscess
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Oral candidiasis
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Osteomyelitis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Parotitis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Pneumonia
|
10.4%
16/154 • Within 365 days
|
8.5%
7/82 • Within 365 days
|
|
Infections and infestations
Pneumonia escherichia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Pneumonia streptococcal
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Post procedural pneumonia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Pseudomonas infection
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Sepsis
|
1.3%
2/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Staphylococcal infection
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Taeniasis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Infections and infestations
Tracheitis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Urinary tract infection
|
11.0%
17/154 • Within 365 days
|
8.5%
7/82 • Within 365 days
|
|
Infections and infestations
Urosepsis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
3/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Bacterial test positive
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Haemoglobin increased
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
International normalised ratio increased
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Investigations
Liver function test abnormal
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Liver function test increased
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Prothrombin time prolonged
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
Transaminases increased
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Investigations
Troponin increased
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Investigations
White blood cell count increased
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Alcoholic ketoacidosis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Cerebral salt-wasting syndrome
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
3/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.6%
4/154 • Within 365 days
|
7.3%
6/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.3%
2/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.2%
8/154 • Within 365 days
|
6.1%
5/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.65%
1/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.9%
6/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
3/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal cancer
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Brain midline shift
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.6%
4/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Cerebral infarction
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Cytotoxic oedema
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Diabetic neuropathy
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Dizziness
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Encephalopathy
|
1.9%
3/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
External hydrocephalus
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Headache
|
3.2%
5/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Hemiparesis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Hydrocephalus
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Hypoaesthesia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Intracranial pressure increased
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Intraventricular haemorrhage
|
2.6%
4/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Loss of consciousness
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Memory impairment
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Migraine
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Muscle spasticity
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Paraesthesia
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Paraparesis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Paroxysmal sympathetic hyperactivity
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Seizure
|
7.8%
12/154 • Within 365 days
|
8.5%
7/82 • Within 365 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Subdural hygroma
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Syncope
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Nervous system disorders
Tremor
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Agitation
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
1.9%
3/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Delirium
|
3.2%
5/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Mental status changes
|
0.65%
1/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Psychiatric disorders
Staring
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
5/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Renal and urinary disorders
Urinary retention
|
5.2%
8/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.9%
3/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
4/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.6%
4/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.65%
1/154 • Within 365 days
|
2.4%
2/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract oedema
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.3%
2/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.3%
2/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Surgical and medical procedures
Subdural haematoma evacuation
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Surgical and medical procedures
Tracheostomy
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Deep vein thrombosis
|
3.2%
5/154 • Within 365 days
|
4.9%
4/82 • Within 365 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Vascular disorders
Hypertension
|
1.3%
2/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Hypertensive urgency
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Hypotension
|
1.9%
3/154 • Within 365 days
|
3.7%
3/82 • Within 365 days
|
|
Vascular disorders
Poor venous access
|
0.65%
1/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Thrombophlebitis
|
0.65%
1/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
|
Vascular disorders
Thrombophlebitis superficial
|
3.2%
5/154 • Within 365 days
|
0.00%
0/82 • Within 365 days
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/154 • Within 365 days
|
1.2%
1/82 • Within 365 days
|
Additional Information
Brooke Lawson, Sr. Director, Clinical Research- Neuro
Penumbra, Inc.
Phone: 510-440-5699
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60