Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial | NCT01369069

ID	Type	Description	Link
U01NS069498	U.S. NIH Grant/Contract		View source

Name	Class
Neurological Emergencies Treatment Trials Network (NETT)	NETWORK
Medical University of South Carolina	OTHER
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Label	Type	Description	Intervention Names
IV insulin drip with target glucose 80 mg/dL - 130 mg/dL	Experimental	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.	Drug: IV insulin to maintain target glucose concentration of 80-130 mg/dL
Sub Q insulin to keep glucose less than 180 mg/dL	Active Comparator	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL	Drug: Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL

Name	Type	Description	Arm Group Labels	Other Names
IV insulin to maintain target glucose concentration of 80-130 mg/dL	Drug	Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.

Measure	Description	Time Frame
Number of Participants With a Favorable Modified Rankin Scale (Yes/No)	Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.	90 days (-14/+30 days)
Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)	Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.	72 hours

Measure	Description	Time Frame
Number of Participants With a Favorable NIHSS	The NIHSS (National Institutes of Health Stroke Scale) score ranges from 0 to 42, with higher scores indicating greater neurological deficits. A favorable NIHSS was defined as a score of 0 or 1 on the NIHSS at 90 days post randomization.	Follow up (Max 164 days)

Measure	Description	Time Frame
Death	Death from any cause	90 days (+30 days)

Name	Affiliation	Role
Karen C Johnston, MD, MSc	University of Virginia	Study Chair
Christiana Hall, MD, MS	UT Southwestern	Principal Investigator
Askiel Bruno, MD, MS	Augusta University	Principal Investigator
Valerie Durkalski, PhD	Medical University of South Carolina	Principal Investigator
William Barsan, MD	University of Michigan	Principal Investigator
Kevin Barrett, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona Medical Center - South Campus		Tucson	Arizona	85713	United States
University of Arizona

PubMed Identifier	Type	Citation	Retractions
31334795	Result	Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346.
38626363	Derived

Label	URL
General information of trial	View source

ID	Title	Description
FG000	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 23, 2012	Sep 11, 2019

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

Number of Participants With a Favorable Modified Rankin Scale (Yes/No)

Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.

Posted

Count of Participants

Participants

90 days (-14/+30 days)

ID	Title	Description
OG000	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
OG001	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

Units	Counts
Participants	OG000581 OG001570

Title

Denominators

Categories

Title	Measurements
	OG000119 OG001123

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	It was hypothesized that intensive blood glucose control would be efficacious and safe in acute ischemic stroke patients compared to standard glucose control.	Regression, Logistic		0.55	The a priori threshold for statistical significance was 0.05.	Risk Ratio (RR)	0.97			2-Sided	95	0.87	1.08			Adjusted for baseline NIHSS strata (3-7, 8-14, 15-22) and thrombolysis use (Yes/No; includes both IV and IA therapies). Multiple imputation was used for missing data.		Superiority

Primary

Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)

Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.

Posted

Count of Participants

Participants

72 hours

ID	Title	Description
OG000	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
OG001	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

Units	Counts

Secondary

Number of Participants With a Favorable NIHSS

The NIHSS (National Institutes of Health Stroke Scale) score ranges from 0 to 42, with higher scores indicating greater neurological deficits. A favorable NIHSS was defined as a score of 0 or 1 on the NIHSS at 90 days post randomization.

Posted

Count of Participants

Participants

Follow up (Max 164 days)

ID	Title	Description
OG000	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
OG001	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

Secondary

Number of Participants With a Favorable Barthel Index

Favorable outcomes for the Barthel Index was defined as a score of 95-100 on the BI at 90 days post randomization. Barthel - Barthel Index for Activities of Daily Living (ADL) assesses functional independence, generally in stroke patients. Scores range from 0-100 with higher scores indicating greater ability to perform activities of daily living.

Posted

Count of Participants

Participants

Follow up (Max 164 days)

ID	Title	Description
OG000	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
OG001	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

Secondary

Stroke Specific Quality of Life (SSQOL)

Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life

Posted

Median

Inter-Quartile Range

score on a scale

Follow up (Max 164 days)

ID	Title	Description
OG000	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
OG001	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

Units	Counts
Participants

Other Pre-specified

Death

Death from any cause

Posted

Count of Participants

Participants

90 days (+30 days)

ID	Title	Description
OG000	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
OG001	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0013 events2 affected570 at risk
Other (combined AEs happened only once)	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0006 events6 affected581 at risk EG0010 events0 affected570 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0009 events8 affected581 at risk EG0014 events4 affected570 at risk
Atrial flutter	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Bradycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Cardiac arrest	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG00010 events7 affected581 at risk EG0017 events7 affected570 at risk
Cardiac failure	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events3 affected581 at risk EG0015 events5 affected570 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0012 events2 affected570 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0013 events3 affected570 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0012 events2 affected570 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events1 affected570 at risk
Myocardial infarction	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0006 events6 affected581 at risk EG0015 events5 affected570 at risk
Other (combined AEs happened only once)	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0013 events3 affected570 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events1 affected581 at risk EG0013 events3 affected570 at risk
Other (combined AEs happened only once)	Ear and labyrinth disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events1 affected570 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events2 affected581 at risk EG0013 events3 affected570 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0016 events6 affected570 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Chest pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0014 events3 affected570 at risk
Device occlusion	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Multi-organ failure	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Pyrexia	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events1 affected581 at risk EG0013 events3 affected570 at risk
Sudden death	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Immune system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Bacteraemia	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events1 affected570 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Endocarditis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0005 events5 affected581 at risk EG0013 events3 affected570 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG00016 events15 affected581 at risk EG00114 events14 affected570 at risk
Sepsis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0007 events7 affected581 at risk EG00115 events14 affected570 at risk
Septic shock	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Skin infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0007 events7 affected581 at risk EG0014 events4 affected570 at risk
Urosepsis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0012 events2 affected570 at risk
Wound infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0012 events2 affected570 at risk
International normalised ratio increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0012 events2 affected570 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0017 events7 affected570 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG00028 events21 affected581 at risk EG0014 events2 affected570 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0013 events3 affected570 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0002 events1 affected581 at risk EG0010 events0 affected570 at risk
Brain oedema	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00010 events10 affected581 at risk EG00111 events11 affected570 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 events4 affected581 at risk EG0014 events4 affected570 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00010 events10 affected581 at risk EG00112 events12 affected570 at risk
Convulsion	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0007 events7 affected581 at risk EG0018 events8 affected570 at risk
Embolic stroke	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0010 events0 affected570 at risk
Encephalopathy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0015 events4 affected570 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0014 events4 affected570 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00037 events36 affected581 at risk EG00128 events27 affected570 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Hydrocephalus	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00016 events16 affected581 at risk EG00121 events16 affected570 at risk
Neurological decompensation	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0007 events7 affected581 at risk EG00118 events17 affected570 at risk
Neurological symptom	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0012 events2 affected570 at risk
Stroke in evolution	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0009 events9 affected581 at risk EG00111 events11 affected570 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Syncope	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 events4 affected581 at risk EG0014 events4 affected570 at risk
Tremor	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Agitation	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Delirium	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Mental disorder	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events2 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0013 events3 affected570 at risk
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0013 events2 affected570 at risk
Other (combined AEs happened only once)	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0013 events3 affected570 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0008 events8 affected581 at risk EG0017 events7 affected570 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0014 events3 affected570 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0012 events2 affected570 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0012 events2 affected570 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0006 events5 affected581 at risk EG0018 events8 affected570 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0006 events6 affected581 at risk EG0015 events5 affected570 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0013 events3 affected570 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00016 events15 affected581 at risk EG00110 events10 affected570 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Hospitalisation	Surgical and medical procedures	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Surgical and medical procedures	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0013 events3 affected570 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 events4 affected581 at risk EG0013 events3 affected570 at risk
Embolism	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Haematoma	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 events5 affected581 at risk EG0012 events2 affected570 at risk
Other (combined AEs happened only once)	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0016 events6 affected570 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0012 events2 affected570 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0013 events3 affected570 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0009 events9 affected581 at risk EG0019 events9 affected570 at risk
Bradycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0013 events3 affected570 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Congenital, familial and genetic disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Hypothyroidism	Endocrine disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0013 events3 affected570 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0006 events5 affected581 at risk EG0018 events8 affected570 at risk
Catheter site haematoma	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Chest pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Other (combined AEs happened only once)	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0012 events2 affected570 at risk
Pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Pyrexia	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0007 events7 affected581 at risk EG0015 events5 affected570 at risk
Other (combined AEs happened only once)	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Hypersensitivity	Immune system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Endocarditis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0014 events4 affected570 at risk
Sepsis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG00012 events12 affected581 at risk EG0015 events5 affected570 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0010 events0 affected570 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0013 events3 affected570 at risk
Other (combined AEs happened only once)	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0011 events1 affected570 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Blood chloride increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0012 events2 affected570 at risk
Blood cholesterol increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Blood creatinine decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Blood potassium decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Blood sodium decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Carbon dioxide decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
High density lipoprotein decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
International normalised ratio increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00012 events8 affected581 at risk EG00112 events9 affected570 at risk
Red cell distribution width increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Troponin increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
White blood cell count increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0011 events1 affected570 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0013 events3 affected570 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG000574 events311 affected581 at risk EG00126 events16 affected570 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG00014 events14 affected581 at risk EG0013 events3 affected570 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0006 events6 affected581 at risk EG0013 events3 affected570 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0012 events2 affected570 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0013 events3 affected570 at risk
Brain oedema	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 events5 affected581 at risk EG0011 events1 affected570 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Convulsion	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Encephalopathy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0012 events2 affected570 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00023 events23 affected581 at risk EG00113 events13 affected570 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00012 events11 affected581 at risk EG0017 events7 affected570 at risk
Neurological decompensation	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00011 events10 affected581 at risk EG0018 events8 affected570 at risk
Neurological symptom	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0006 events6 affected581 at risk EG0012 events2 affected570 at risk
Stroke in evolution	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Tremor	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Agitation	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Delirium	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Mental disorder	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Other (combined AEs happened only once)	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0012 events2 affected570 at risk
Other (combined AEs happened only once)	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0011 events1 affected570 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0012 events2 affected570 at risk
Other (combined AEs happened only once)	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 events2 affected581 at risk EG0011 events1 affected570 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0012 events2 affected570 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk
Haematoma	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0010 events0 affected570 at risk
Haemorrhage	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 events4 affected581 at risk EG0015 events5 affected570 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 events3 affected581 at risk EG0012 events2 affected570 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 events5 affected581 at risk EG0014 events4 affected570 at risk
Malignant hypertension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Other (combined AEs happened only once)	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 events1 affected581 at risk EG0011 events1 affected570 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 events0 affected581 at risk EG0011 events1 affected570 at risk

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
BG001	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.
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	IV Insulin Drip With Target Glucose 80 mg/dL - 130 mg/dL	The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range. IV insulin to maintain target glucose concentration of 80-130 mg/dL: Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.	54	581	209	581	384	581
EG001	Sub Q Insulin to Keep Glucose Less Than 180 mg/dL	This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL: Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.	65	570	198	570	134	570

ID	Term
D000083242	Ischemic Stroke
D003920	Diabetes Mellitus
D006943	Hyperglycemia
D020521	Stroke