Effects of Voluven on Hemodynamics and Tolerability of En... | NCT00464204

ID	Type	Description	Link
2006-004350-25	EudraCT Number

Label	Type	Description	Intervention Names
Voluven® Arm	Experimental		Drug: 6 % Hydroxyethylstarch 130/0.4 = "Voluven®"
0.9 % NaCl	Active Comparator		Drug: 0.9 % NaCl

Name	Type	Description	Arm Group Labels	Other Names
6 % Hydroxyethylstarch 130/0.4 = "Voluven®"	Drug	Voluven® was administered intravenously. Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day on the second to fourth days, according to patient needs.

Measure	Description	Time Frame
Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization	Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.	until hemodynamic stabilization (up to 48 hours)

Measure	Description	Time Frame
Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization	Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization	until hemodynamic stabilization (up to 48 hours)
Quantity of Study Drug in 4 Days

Measure	Description	Time Frame
Mortality	Mortality was reported for the time period from Screening until the end of follow-up.	From Screening to end of Follow-up
Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening

Name	Affiliation	Role
Bertrand Guidet, Prof., MD	Hôpital St Antoine, Réanimation Médicale	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Sud, Unité de Réanimation Médicale		Amiens		80054	France
Centre Hospitalier d'Avignon, Service de Réanimation Polyvalente

PubMed Identifier	Type	Citation	Retractions
22624531	Derived	Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study. Crit Care. 2012 May 24;16(3):R94. doi: 10.1186/cc11358.

ID	Title	Description
FG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
FG001	NaCl 0.9 % Arm

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

Amount of Study Drug Required to Achieve Initial Hemodynamic Stabilization

Initial hemodynamic stabilization (HDS) was defined as normalization of mean arterial pressure (MAP) and at least two of the three parameters central venous pressure (CVP), urine output and central venous oxygen saturation and maintaining this normalization over a period of four hours, with no increase in the infusion of vasopressors, or ionotropic therapy and with no more than 1 L of additional study drug administration within these four hours.

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.

Posted

Mean

Standard Deviation

Milliliter

until hemodynamic stabilization (up to 48 hours)

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants	OG00088 OG00186

Title

Denominators

Categories

Title	Measurements
	OG0001379± 886 OG0011709± 1164

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	Null-hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization in patients treated with Voluven® is higher than or equal to this amount in patients treated with NaCl. Alternative hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization is lower in patients treated with Voluven® than in patients treated with NaCl.	t-test, 1 sided		0.0185	One-sided t-test assuming unequal variances (as variances were significantly different between treatment groups).No multiple comparisons were made. A priori threshold for statistical significance for the confirmatory analysis on FAS: 0.025 one-sided.	Mean Difference (Final Values)	-331	Standard Deviation	1033	2-Sided	95	-640	-21

Secondary

Time From Start of Fluid Resuscitation With Study Drug to the Initial Hemodynamic Stabilization

Time from start of fluid resuscitation with study drug to the initial hemodynamic stabilization

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization

Posted

Mean

Standard Deviation

Hours

until hemodynamic stabilization (up to 48 hours)

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants	OG000

Secondary

Quantity of Study Drug in 4 Days

Total quantity of study drug infused over four consecutive days in the ICU

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization

Posted

Mean

Standard Deviation

Milliliter

4 days

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants	OG000

Secondary

Time From Start of Study Drug to Start of Enteral Nutrition in the Subgroup of Patients Who Received Enteral Nutrition

Time from start of fluid resuscitation with study drug to start of enteral nutrition.

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization

Posted

Mean

Standard Deviation

Hours

Until start of enteral nutrition (up to 48 hours)

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants	OG000

Secondary

Time From Start of Fluid Resuscitation With Study Drug to Start of Enteral Nutrition After Hemodynamic Stabilization

Administration of enteral nutrition before initial hemodynamic stabilization was ignored in this analysis.

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization

Posted

Mean

Standard Deviation

Hours

up to 48 hours

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants	OG000

Secondary

Total Amount of Enteral Calories During the First Seven Days of Enteral Nutrition

This amount will be calculated from start of enteral nutrition until 7 am of day 8

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization

Posted

Mean

Standard Deviation

kcal

7 days

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants	OG000

Secondary

Length of Stay in the Intensive Care Unit (ICU)

Length of stay was analysed in two approaches. First, it was calculated and analysed only for patients who did not die before end of study of the individual patient. As a sensitivity analysis, the analysis was carried out including patients who died with the maximum possible length of stay (i.e., the worst possible value).

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.

Calculated for patients who did not die before end of study of the individual patient

Posted

Mean

Standard Deviation

Days

Until discharge from ICU (up to day 90)

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants

Secondary

Length of Stay in the ICU

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.

Imputed with the longest possible duration for patients who died before end of the study of the individual patient.

Posted

Mean

Standard Deviation

Days

Until discharge from ICU (up to Day 90)

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants

Secondary

Length of Stay in the Hospital

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.

Calculated for patients who did not die before end of study of the individual patient.

Posted

Mean

Standard Deviation

Days

Until discharge from hospital (up to day 90)

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants

Secondary

Length of Stay in the Hospital

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization.

Imputed with the longest possible duration for patients who died before end of the study of the individual patient.

Posted

Mean

Standard Deviation

Days

Until discharge from hospital (up to Day 90)

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants

Secondary

Area Under the Curve (AUC) of Sepsis-related Organ Failure Assessment (SOFA) Score Per Day From Screening to Day 4

The Sepsis-related Organ Failure Assessment (SOFA) score in this study is reported for entire days, not for exact time points on a day. Potentially, more than one SOFA score may be available for the same day. In this case, the mean of the respective total scores was used for that day for calculation of Area Under the Curve (AUC).

The SOFA score includes sub-scores for Respiration, Coagulation, Liver, Cardiovascular, Central Nervous System and Renal function and may range from 0 (worst outcome) to 4 (best outcome).

Full analysis set (FAS) = all randomized patients treated with study drug who reached hemodynamic stabilization

Posted

Mean

Standard Deviation

Scores on a scale

From Screening to Day 4

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts

Other Pre-specified

Mortality

Mortality was reported for the time period from Screening until the end of follow-up.

Treated population (TRT) = all randomized patients treated with study drug. Two patients in the Voluven® arm died due to non-treatment emergent SAEs.

Posted

Number

Participants

From Screening to end of Follow-up

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4 Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day.
OG001	NaCl 0.9 % Arm	NaCl 0.9 % NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants	OG000

Other Pre-specified

Changes in Renal Function: 1. Acute Renal Failure (ARF) at Any Time After Screening

Acute Renal Failure (ARF) was defined as a two fold increase in serum concentration over the value at screening at any time after screening.

Treated population (TRT) = all randomized patients treated with study drug. Patients without ARF were excluded from analysis if they had no creatinine value at Screening or no post-screening creatinine value.

Posted

Number

Participants

From screening to end of follow-up (up to day 90)

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts
Participants	OG000

Other Pre-specified

Changes in Renal Function: 2. Acute Kidney Injury Network (AKIN) Classification

Acute Kidney Injury Network (AKIN) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study. AKIN ranges from stage 1 to stage 3 (worst outcome). Stages differ in serum creatinine increase. Stage 1: Increase ≥ 0.3mg/dL or ≥ 150%-200% from reference; Stage 2: Increase ≥ 200%-300% from reference; Stage 3: Increase >300% from reference with an acute increase of at least 0.5mg/dL or renal replacement therapy.

Treated population (TRT) = all randomized patients treated with study drug

Posted

Number

Participants

From screening to end of follow-up

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts

Other Pre-specified

Changes in Renal Function: 3. Risk, Injury, Failure, Loss, End-stage Kidney Disease (RIFLE) Classification

Risk, Injury, Failure, Loss, End-stage kidney disease (RIFLE) Classification in this study is based on serum creatinine values and renal replacement therapy, i.e. ignoring criteria based on urine output, as fulfilment of urine output criteria cannot be determined from the data collected in the study.

RIFLE comprises five categories: Risk (R), Injury (I), Failure (F), Loss (L), End-stage kidney disease (E) (worst outcome). R, I and F are based on increase in serum creatinine. L and E are based on administration of renal replacement therapy.

Treated population (TRT) = all randomized patients treated with study drug

Posted

Number

Participants

From screening to end of follow-up

ID	Title	Description
OG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
OG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0005 affected100 at risk EG0016 affected96 at risk
Cardiac tamponade	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Peritonitis	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Condition aggravated	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0004 affected100 at risk EG0010 affected96 at risk
Multi-organ failure	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0007 affected100 at risk EG0015 affected96 at risk
Oedema due to cardiac disease	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Sudden death	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Abdominal sepsis	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Pneumonia	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0004 affected100 at risk EG0013 affected96 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Sepsis	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0013 affected96 at risk
Septic shock	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0009 affected100 at risk EG0018 affected96 at risk
Haemodilution	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0008 affected100 at risk EG0019 affected96 at risk
Tracheal haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Blood chloride increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Venous oxygen saturation decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Marasmus	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Pleural carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Cerebral disorder	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Coma	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0013 affected96 at risk
Renal failure acute	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0012 affected96 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0012 affected96 at risk
Acute pulmonary oedema	Reproductive system and breast disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected96 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0012 affected96 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected96 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0012 affected96 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Respiratory fatigue	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Withdrawal of life support	Surgical and medical procedures	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hypotension	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Peripheral ischaemia	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Shock	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected96 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG00022 affected100 at risk EG00121 affected96 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0014 affected96 at risk
Hypocoagulable state	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0014 affected96 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0006 affected100 at risk EG0016 affected96 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0006 affected100 at risk EG0010 affected96 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0012 affected96 at risk
Atrial flutter	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Bradycardia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0013 affected96 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Cardiac failure	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Cyanosis	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Sinus tachycardia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0012 affected96 at risk
Tachycardia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0009 affected100 at risk EG0019 affected96 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Diabetes insipidus	Endocrine disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Pupils unequal	Eye disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0013 affected96 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0007 affected100 at risk EG0015 affected96 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0009 affected100 at risk EG00116 affected96 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG00017 affected100 at risk EG00122 affected96 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected96 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0012 affected96 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Malaena	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0013 affected96 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Regurgitation	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0013 affected96 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 13.1	Systematic Assessment	EG00015 affected100 at risk EG00117 affected96 at risk
Chest pain	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Device breakage	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Generalised oedema	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Oedema	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0014 affected96 at risk
Oedema due to cardiac disease	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Oedema peripheral	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0011 affected96 at risk
Pain	General disorders	MedDRA Version 13.1	Systematic Assessment	EG0004 affected100 at risk EG0014 affected96 at risk
Pyrexia	General disorders	MedDRA Version 13.1	Systematic Assessment	EG00013 affected100 at risk EG0013 affected96 at risk
Cholangiolitis	Hepatobiliary disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Cholestasis	Hepatobiliary disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0012 affected96 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Acute sinusitis	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Bronchitis	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Candidiasis	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Fungal skin infection	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0012 affected96 at risk
Herpes simplex	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Infection	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected96 at risk
Oral herpes	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Peritoneal abscess	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Pneumonia	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0004 affected100 at risk EG0013 affected96 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Post procedural infection	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Septic shock	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Tuberculosis	Infections and infestations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Airway complication of anaesthesia	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Failure to anastomose	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Haemodilution	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0009 affected100 at risk EG00110 affected96 at risk
Mechanical ventilation complication	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Open wound	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Aspiration bronchial	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Blood bicarbonate decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Blood bicarbonate increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Blood creatine increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Blood creatinine increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Blood potassium decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Blood pressure diastolic increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Blood pressure systolic increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Blood urea increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0012 affected96 at risk
Central venous pressure decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected96 at risk
Coagulation test abnormal	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Haemoglobin decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Mean arterial pressure decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Oxygen saturation decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0012 affected96 at risk
PO2 decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
PO2 increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Red blood cell count decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Urine output decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG00019 affected100 at risk EG00115 affected96 at risk
Venous oxygen saturation decreased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0006 affected100 at risk EG00112 affected96 at risk
Weight increased	Investigations	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0007 affected100 at risk EG00113 affected96 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG00016 affected100 at risk EG00114 affected96 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG00023 affected100 at risk EG00128 affected96 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0013 affected96 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0007 affected100 at risk EG0013 affected96 at risk
Hyperlactacidaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0011 affected96 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0014 affected96 at risk
Hyperproteinaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected96 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0010 affected96 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0009 affected100 at risk EG00112 affected96 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG00022 affected100 at risk EG00129 affected96 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0014 affected96 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG00029 affected100 at risk EG00122 affected96 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0013 affected96 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0006 affected100 at risk EG0011 affected96 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Vitamin K deficiency	Metabolism and nutrition disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Brain injury	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Convulsion	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0013 affected96 at risk
Critical illness polyneuropathy	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Headache	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0012 affected96 at risk
Myoclonus	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Agitation	Psychiatric disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG00112 affected96 at risk
Anxiety	Psychiatric disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0013 affected96 at risk
Confusional state	Psychiatric disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0011 affected96 at risk
Delirium	Psychiatric disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0011 affected96 at risk
Depression	Psychiatric disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Hallucination	Psychiatric disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Azotaemia	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0004 affected100 at risk EG0010 affected96 at risk
Oliguria	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0004 affected100 at risk EG0015 affected96 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0008 affected100 at risk EG0016 affected96 at risk
Renal failure acute	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0007 affected100 at risk EG0010 affected96 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0012 affected96 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0003 affected100 at risk EG0010 affected96 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0004 affected100 at risk EG0010 affected96 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0004 affected100 at risk EG0013 affected96 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hypocapnia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG00033 affected100 at risk EG00135 affected96 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0012 affected96 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0006 affected100 at risk EG0014 affected96 at risk
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0006 affected100 at risk EG0016 affected96 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0013 affected96 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0002 affected100 at risk EG0010 affected96 at risk
Livedo reticularis	Skin and subcutaneous tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0011 affected96 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Haematoma	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Hypertension	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG0009 affected100 at risk EG0018 affected96 at risk
Hypotension	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG00035 affected100 at risk EG00138 affected96 at risk
Labile hypertension	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Peripheral ischaemia	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG0000 affected100 at risk EG0011 affected96 at risk
Venous thrombosis	Vascular disorders	MedDRA Version 13.1	Systematic Assessment	EG0001 affected100 at risk EG0010 affected96 at risk

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C485123	HES 130-0.4
D012965	Sodium Chloride

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Title	Description
BG000	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
BG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
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	Voluven® Arm	6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day			53	100	99	100
EG001	NaCl 0.9 % Arm	NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day			44	96	95	96