MIND: Artemis in the Removal of Intracerebral Hemorrhage | NCT03342664

Label	Type	Description	Intervention Names
Artemis + Medical Management (MIS)	Experimental	Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management	Device: Artemis + Medical Management
Best Medical Management Alone (MM)	Active Comparator	Best medical management alone per standard of care at treating institution	Other: Best Medical Management Alone (MM)

Name	Type	Description	Arm Group Labels	Other Names
Artemis + Medical Management	Device	Subject will receive best MM in addition to the MIS procedure with Artemis.	Artemis + Medical Management (MIS)

Measure	Description	Time Frame
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)	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	180 days
Rate of Mortality		30 days

Measure	Description	Time Frame
Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)	The 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.

Facility	Status	City	State	ZIP	Country	Contacts
Abrazo Central		Phoenix	Arizona	85015	United States
UCLA

PubMed Identifier	Type	Citation	Retractions
40892424	Derived	Arthur AS, Jahromi BS, Saphier PS, Nickele CM, Ryan RW, Vajkoczy P, Schirmer CM, Kellner CP, Matouk CC, Arias EJ, Ullman JS, Levitt MR, Hage ZA, Fiorella DJ; MIND Study Investigators and Collaborators. Minimally Invasive Surgery vs Medical Management Alone for Intracerebral Hemorrhage: The MIND Randomized Clinical Trial. JAMA Neurol. 2025 Nov 1;82(11):1113-1121. doi: 10.1001/jamaneurol.2025.3151.
39921231

ID	Title	Description
FG000	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.
FG001	Best Medical Management Alone (MM)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 14, 2020	Oct 23, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)

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

As treated population

Posted

Count of Participants

Participants

180 days

ID	Title	Description
OG000	Artemis + Medical Management (MIS)	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.
OG001	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.

Units	Counts
Participants	OG000154 OG00182

Title

Denominators

Categories

Missing mRS value

Title	Measurements
	OG00032 OG00120

mRS 0

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Odds Ratio (OR)	1.03			2-Sided	96	0.62	1.72			Odds ratio of MIS over MM with value above 1 indicating a better outcome for MIS		Other

Primary

Rate of Mortality

As treated population

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)

The 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.

Posted

Mean

Standard Deviation

score on a scale

180 days

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)

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

As treated population

Posted

Count of Participants

Participants

365 days

ID	Title	Description
OG000	Artemis + Medical Management (MIS) All Participants All 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.
OG001	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.

Units	Counts
Participants

Secondary

Quality of Life Assessed Via Stroke Impact Scale

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.

Numbers analyzed at 180 and 365 are dependent on data available from follow up visits.

Posted

Mean

Standard Deviation

score on a scale

180 and 365 days

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

VAS Quality of Life Assessed Via EQ-5D-5L

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.

The number analyzed at 180 and 365 days are dependent on data available for participants completing visits.

Posted

Mean

Standard Deviation

score on a scale

180 and 365 days

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Length of Hospital Stay

All subjects

Posted

Mean

Standard Deviation

days

Admission to hospital discharge (up to one year)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Length of ICU

All subjects

Posted

Mean

Standard Deviation

days

# of days from admission (up to one year)

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Length of Procedure

all subjects (ITT), one participant was randomized to MM but received MIS treatment

Posted

Mean

Standard Deviation

minutes

Time from initial sheath placement to final sheath removal

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3

(0 no symptoms - 3 moderate disability)

All subjects

Posted

Count of Participants

Participants

180 days

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2

mRS 0 no symptoms - 2 slight disability

All subjects

Posted

Count of Participants

Participants

180 days

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Leukocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Microcytic anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Normocytic anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Atrioventricular block	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Cardiac arrest	Cardiac disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Cardio-respiratory arrest	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Cardiomegaly	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Diastolic dysfunction	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pulseless electrical activity	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Sinus bradycardia	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Sinus node dysfunction	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Sinus tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Tachyarrhythmia	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Diplopia	Eye disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Visual impairment	Eye disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Barrett's oesophagus	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Colitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Dysphagia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0012 affected82 at risk
Enterocolitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Erosive oesophagitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Gastric haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Gastritis erosive	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0010 affected82 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Haematochezia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Ileus	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Ileus paralytic	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Melaena	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Oesophagitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Oral pain	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Small intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Subileus	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0012 affected82 at risk
Impaired healing	General disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Non-cardiac chest pain	General disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pain	General disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Acute hepatic failure	Hepatobiliary disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Cholecystitis	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Cholecystitis acute	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Liver injury	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Anaphylactic reaction	Immune system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Anal abscess	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Bacteraemia	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Blister infected	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Burn infection	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
COVID-19	Infections and infestations	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Clostridium difficile colitis	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Clostridium difficile infection	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Eye infection bacterial	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Infectious pleural effusion	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Klebsiella infection	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Liver abscess	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Necrotising fasciitis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Oral candidiasis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Osteomyelitis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0013 affected82 at risk
Parotitis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0004 affected154 at risk EG0017 affected82 at risk
Pneumonia escherichia	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pneumonia staphylococcal	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Pneumonia streptococcal	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Post procedural pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pseudomonas infection	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pulmonary sepsis	Infections and infestations	Non-systematic Assessment	EG0002 affected154 at risk EG0012 affected82 at risk
Sepsis	Infections and infestations	Non-systematic Assessment	EG0004 affected154 at risk EG0019 affected82 at risk
Septic encephalopathy	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Septic shock	Infections and infestations	Non-systematic Assessment	EG0003 affected154 at risk EG0010 affected82 at risk
Sputum purulent	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Staphylococcal infection	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Taeniasis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Tracheitis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0004 affected154 at risk EG0012 affected82 at risk
Urosepsis	Infections and infestations	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Vulvovaginal mycotic infection	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Gastrostomy tube site complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Haematuria traumatic	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hip fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Humerus fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Intentional overdose	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Procedural nausea	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 affected154 at risk EG0011 affected82 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Unintentional medical device removal	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0012 affected82 at risk
Urethral injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Weaning failure	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Wound dehiscence	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Bacterial test positive	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Haemoglobin increased	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
International normalised ratio increased	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Liver function test abnormal	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Liver function test increased	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Prothrombin time prolonged	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Transaminases increased	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Troponin increased	Investigations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
White blood cell count increased	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Alcoholic ketoacidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Cerebral salt-wasting syndrome	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Failure to thrive	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Fluid overload	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hyperchloraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hypernatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hypervolaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hypocalcaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hypokalaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hyponatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Metabolic acidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Altered state of consciousness	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Brain midline shift	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Brain oedema	Nervous system disorders	Non-systematic Assessment	EG0004 affected154 at risk EG00110 affected82 at risk
Cerebral haematoma	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Cerebral haemorrhage	Nervous system disorders	Non-systematic Assessment	EG00017 affected154 at risk EG0013 affected82 at risk
Cerebral infarction	Nervous system disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0012 affected82 at risk
Cerebrospinal fluid leakage	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Cerebrovascular accident	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Cytotoxic oedema	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Diabetic neuropathy	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Embolic cerebral infarction	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Embolic stroke	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Encephalopathy	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Epilepsy	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
External hydrocephalus	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Generalised tonic-clonic seizure	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Haemorrhage intracranial	Nervous system disorders	Non-systematic Assessment	EG0007 affected154 at risk EG0012 affected82 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hemiparesis	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0011 affected82 at risk
Hydrocephalus	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0011 affected82 at risk
Hypoaesthesia	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
IIIrd nerve paralysis	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Intracranial pressure increased	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Intraventricular haemorrhage	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Ischaemic cerebral infarction	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Ischaemic stroke	Nervous system disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0014 affected82 at risk
Lethargy	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Loss of consciousness	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Memory impairment	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Muscle spasticity	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Neurological decompensation	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Paraesthesia	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Paraparesis	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Paroxysmal sympathetic hyperactivity	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Presyncope	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Restless legs syndrome	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Seizure	Nervous system disorders	Non-systematic Assessment	EG0006 affected154 at risk EG0011 affected82 at risk
Somnolence	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Status epilepticus	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Stroke in evolution	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0012 affected82 at risk
Subarachnoid haemorrhage	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Subdural hygroma	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Transient ischaemic attack	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Tremor	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Agitation	Psychiatric disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Delirium	Psychiatric disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Mental status changes	Psychiatric disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Staring	Psychiatric disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Suicidal ideation	Psychiatric disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0013 affected82 at risk
Chronic kidney disease	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Haematuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Nephrolithiasis	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Renal artery stenosis	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Urinary retention	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0013 affected82 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0013 affected82 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0006 affected154 at risk EG0016 affected82 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0010 affected82 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0006 affected154 at risk EG0014 affected82 at risk
Respiratory tract oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Total	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0012 affected82 at risk
Blister	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0012 affected82 at risk
Dermatitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Rash macular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Subdural haematoma evacuation	Surgical and medical procedures	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Tracheostomy	Surgical and medical procedures	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0009 affected154 at risk EG0019 affected82 at risk
Haematoma	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0012 affected82 at risk
Hypertensive emergency	Vascular disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Hypertensive urgency	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Poor venous access	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Thrombophlebitis	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Thrombophlebitis superficial	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Venous thrombosis limb	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Leukocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0006 affected154 at risk EG0012 affected82 at risk
Microcytic anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Normocytic anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0011 affected82 at risk
Atrioventricular block	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0012 affected82 at risk
Cardiac arrest	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Cardio-respiratory arrest	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Cardiomegaly	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Diastolic dysfunction	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Pulseless electrical activity	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Sinus bradycardia	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Sinus node dysfunction	Cardiac disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Sinus tachycardia	Cardiac disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Tachyarrhythmia	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Haemorrhagic arteriovenous malformation	Congenital, familial and genetic disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Diplopia	Eye disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Visual impairment	Eye disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Barrett's oesophagus	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Colitis	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Dysphagia	Gastrointestinal disorders	Non-systematic Assessment	EG00015 affected154 at risk EG00112 affected82 at risk
Enterocolitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Erosive oesophagitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Gastric haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Gastritis erosive	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Haematochezia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Ileus	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Ileus paralytic	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Melaena	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Oesophagitis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Oral pain	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Small intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Subileus	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Impaired healing	General disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Non-cardiac chest pain	General disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Pain	General disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG00013 affected154 at risk EG0016 affected82 at risk
Total	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Acute hepatic failure	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Cholecystitis	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Cholecystitis acute	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Liver injury	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Total	Immune system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Anaphylactic reaction	Immune system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Total	Infections and infestations	Non-systematic Assessment	EG00041 affected154 at risk EG00120 affected82 at risk
Anal abscess	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Bacteraemia	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Blister infected	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Burn infection	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
COVID-19	Infections and infestations	Non-systematic Assessment	EG0004 affected154 at risk EG0010 affected82 at risk
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Clostridium difficile colitis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Clostridium difficile infection	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Eye infection bacterial	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Infectious pleural effusion	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Klebsiella infection	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Liver abscess	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Necrotising fasciitis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Oral candidiasis	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Osteomyelitis	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Parotitis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG00016 affected154 at risk EG0017 affected82 at risk
Pneumonia escherichia	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Pneumonia staphylococcal	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pneumonia streptococcal	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Post procedural pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Pseudomonas infection	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Pulmonary sepsis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Sepsis	Infections and infestations	Non-systematic Assessment	EG0002 affected154 at risk EG0012 affected82 at risk
Septic encephalopathy	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Septic shock	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Sputum purulent	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Staphylococcal infection	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Taeniasis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Tracheitis	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG00017 affected154 at risk EG0017 affected82 at risk
Urosepsis	Infections and infestations	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Vulvovaginal mycotic infection	Infections and infestations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0003 affected154 at risk EG0013 affected82 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Gastrostomy tube site complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Haematuria traumatic	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Hip fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Humerus fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Intentional overdose	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Procedural nausea	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Unintentional medical device removal	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Urethral injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Weaning failure	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Wound dehiscence	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Bacterial test positive	Investigations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Haemoglobin increased	Investigations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
International normalised ratio increased	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Liver function test abnormal	Investigations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Liver function test increased	Investigations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Prothrombin time prolonged	Investigations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Transaminases increased	Investigations	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Troponin increased	Investigations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
White blood cell count increased	Investigations	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Alcoholic ketoacidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Cerebral salt-wasting syndrome	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0012 affected82 at risk
Failure to thrive	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Fluid overload	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Hyperchloraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0010 affected82 at risk
Hypernatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0016 affected82 at risk
Hypervolaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Hypocalcaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0011 affected82 at risk
Hypokalaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0008 affected154 at risk EG0015 affected82 at risk
Hyponatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0013 affected82 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0006 affected154 at risk EG0011 affected82 at risk
Metabolic acidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0010 affected82 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Altered state of consciousness	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Brain midline shift	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Brain oedema	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Cerebral haematoma	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Cerebral haemorrhage	Nervous system disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0010 affected82 at risk
Cerebral infarction	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Cerebrospinal fluid leakage	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Cerebrovascular accident	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Cytotoxic oedema	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Diabetic neuropathy	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Embolic cerebral infarction	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Embolic stroke	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Encephalopathy	Nervous system disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0010 affected82 at risk
Epilepsy	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
External hydrocephalus	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Generalised tonic-clonic seizure	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Haemorrhage intracranial	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0005 affected154 at risk EG0011 affected82 at risk
Hemiparesis	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Hydrocephalus	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Hypoaesthesia	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
IIIrd nerve paralysis	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Intracranial pressure increased	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Intraventricular haemorrhage	Nervous system disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0010 affected82 at risk
Ischaemic cerebral infarction	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Ischaemic stroke	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Lethargy	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Loss of consciousness	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Memory impairment	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Muscle spasticity	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Neurological decompensation	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Paraesthesia	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Paraparesis	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Paroxysmal sympathetic hyperactivity	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Presyncope	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Restless legs syndrome	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Seizure	Nervous system disorders	Non-systematic Assessment	EG00012 affected154 at risk EG0017 affected82 at risk
Somnolence	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Status epilepticus	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Stroke in evolution	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Subarachnoid haemorrhage	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Subdural hygroma	Nervous system disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Transient ischaemic attack	Nervous system disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Tremor	Nervous system disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Agitation	Psychiatric disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0010 affected82 at risk
Delirium	Psychiatric disorders	Non-systematic Assessment	EG0005 affected154 at risk EG0010 affected82 at risk
Mental status changes	Psychiatric disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0012 affected82 at risk
Staring	Psychiatric disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Suicidal ideation	Psychiatric disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0005 affected154 at risk EG0013 affected82 at risk
Chronic kidney disease	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Haematuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0012 affected82 at risk
Nephrolithiasis	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0012 affected82 at risk
Renal artery stenosis	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Urinary retention	Renal and urinary disorders	Non-systematic Assessment	EG0008 affected154 at risk EG0011 affected82 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0013 affected82 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0012 affected82 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0012 affected82 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 affected154 at risk EG0013 affected82 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0012 affected82 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Respiratory tract oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0011 affected82 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Blister	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0010 affected82 at risk
Dermatitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Rash macular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Subdural haematoma evacuation	Surgical and medical procedures	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Tracheostomy	Surgical and medical procedures	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0005 affected154 at risk EG0014 affected82 at risk
Haematoma	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0002 affected154 at risk EG0011 affected82 at risk
Hypertensive emergency	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0010 affected82 at risk
Hypertensive urgency	Vascular disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG0003 affected154 at risk EG0013 affected82 at risk
Poor venous access	Vascular disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0010 affected82 at risk
Thrombophlebitis	Vascular disorders	Non-systematic Assessment	EG0001 affected154 at risk EG0011 affected82 at risk
Thrombophlebitis superficial	Vascular disorders	Non-systematic Assessment	EG0005 affected154 at risk EG0010 affected82 at risk
Venous thrombosis limb	Vascular disorders	Non-systematic Assessment	EG0000 affected154 at risk EG0011 affected82 at risk

ID	Term
D002543	Cerebral Hemorrhage
D020300	Intracranial Hemorrhages
D020521	Stroke
D006470	Hemorrhage
D002561	Cerebrovascular Disorders

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	27	154	89	154	107	154
EG001	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.	16	82	60	82	56	82