Controlled Myelofibrosis Study With Oral Janus-associated... | NCT00934544

ID	Type	Description	Link
CINCB 18424-352	Other Identifier	INCYTE
2009-009858-24	EudraCT Number

Label	Type	Description	Intervention Names
Ruxolitinib	Experimental	5 mg tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule	Drug: Ruxolitinib
Best Available Therapy (BAT)	Active Comparator	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment. Patients randomized to BAT were eligible to cross over to receive open-label ruxolitinib after a qualifying progression event, if they met the safety criteria. After the primary analysis in January 2011, patients randomized to receive BAT were allowed to cross over to receive ruxolitinib and move to the extension phase of the study without a qualifying progression event.	Drug: Best Available Therapy (BAT)

Name	Type	Description	Arm Group Labels	Other Names
Ruxolitinib	Drug	5 mg tablets packaged as 60-count in high-density polyethylene bottles	Ruxolitinib

Measure	Description	Time Frame
Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48	The change in spleen volume from baseline to week 48 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 48 was then calculated by treatment group.	Baseline, Week 48

Measure	Description	Time Frame
Duration of Maintenance of Spleen Volume Reduction (Median)	DoMSR is defined as the interval between the first spleen volume measurement that is >=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a >25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Innsbruck		6020	Austria
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
28962635	Derived	Verstovsek S, Gotlib J, Mesa RA, Vannucchi AM, Kiladjian JJ, Cervantes F, Harrison CN, Paquette R, Sun W, Naim A, Langmuir P, Dong T, Gopalakrishna P, Gupta V. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Oncol. 2017 Sep 29;10(1):156. doi: 10.1186/s13045-017-0527-7.
26380150

ID	Title	Description
FG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
FG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

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

Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48

The change in spleen volume from baseline to week 48 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 48 was then calculated by treatment group.

Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.

Posted

Number

Percentage of Participants

Baseline, Week 48

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Units	Counts
Participants	OG000144 OG00172

Title

Denominators

Categories

Title	Measurements
	OG00028.5 OG0010

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		Cochran-Mantel-Haenszel		<0.0001		Kaplan-Meir estimate	28.1	Standard Deviation	22.123	2-Sided	95	21.3	36.6					Superiority or Other

Secondary

Duration of Maintenance of Spleen Volume Reduction (Median)

DoMSR is defined as the interval between the first spleen volume measurement that is >=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a >25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.

Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.

Posted

Median

95% Confidence Interval

years

Baseline, up to Year 5

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Units	Counts

Secondary

Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates)

This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume.

Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.

Posted

Number

95% Confidence Interval

probability of response

Baseline, up to Year 5

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Units	Counts
Participants

Secondary

Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24

The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group.

Posted

Number

Percentage of Participants

Baseline, Week 24

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Secondary

Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment (Primary Analysis)

This is defined as the interval between randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume

Full analysis set (FAS)

Posted

Number

95% Confidence Interval

probability of response

Time from randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Units	Counts
Participants	OG000

Secondary

Progression-free Survival (PFS)

Median of time progression free survival (95% CI), years

Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.

Posted

Median

95% Confidence Interval

years

Time from randomization and the earliest of either increase in spleen volume >=25% from on-study nadir, splenic irradiation, splenectomy, leukemic transformation or death

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Units	Counts
Participants

Secondary

Leukemia-free Survival (LFS)

Time from randomization and earliest of either (1) date of bone marrow blast count of 20% or greater; (2) date of first peripheral blast count of 20% or greater that was subsequently confirmed to sustain for at least 8 weeks; (3) date of death from any cause

Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.

Posted

Median

95% Confidence Interval

Years

Time from randomization and earliest of either leukemia or death

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Units	Counts
Participants

Secondary

Overall Survival (OS)

Defined as the interval between randomization and the date of the bone marrow blast count of 20% or greater OR the date of the first peripheral blast count of 20% or greater that was subsequently confirmed to have been sustained for at least 8 weeks OR the date of death from any cause, whichever occurs first. OS was summarized using Kaplan-Meier estimates for each treatment arm. The estimates were supplemented by tables of number of events and probability estimates at several timepoints

Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.

Posted

Median

95% Confidence Interval

Years

From randomization until death from any cause

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Secondary

Percentage of Participants With Bone Marrow Histomorphology at Week 48 (Primary Analysis)

This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used.

Fibrosis grades: 0 Scattered linear reticulin with no intersections corresponding to normal bone marrow ; 1 Loose network of reticulin with many intersections, especially in perivascular areas; 2 Diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; 3 Diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis

Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria.

Posted

Number

Percentage of participants

48 weeks

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Secondary

Bone Marrow Histomorphology

Shift table from baseline to last available postbaseline fibrosis grade by treatment

The grade gives an indication of the activity or amount of inflammation and the stage represents the amount of fibrosis or scarring. The grade is assigned a number based on the degree of inflammation, which is usually scored from 0-4 with 0 being no activity and 3 or 4 considered severe activity

Full Analysis Set (FAS)

Numbers of Participants Analyzed reflect only those participants who were randomized to either Ruxolitinib or Best Available Therapy and do not count those participants who could have crossed over to Ruxolitinib

Posted

Number

participants

Baseline, once a year

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Ruxolitinib - Grade 1
OG002	Ruxolitinib - Grade 2
OG003	Ruxolitinib - Grade 3
OG004	Ruxolitinib - Missing

Secondary

Duration of Follow-up by Treatment

Number of Participants with duration of Follow up

Safety Set

Posted

Number

participants

baseline, 260 weeks (end of study)

ID	Title	Description
OG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
OG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected146 at risk EG00110 affected146 at risk EG0024 affected73 at risk EG0032 affected45 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Paratracheal lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Splenic infarction	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0012 affected146 at risk EG0021 affected73 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0021 affected73 at risk EG003
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0014 affected146 at risk EG0021 affected73 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0015 affected146 at risk EG0021 affected73 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0013 affected146 at risk EG0021 affected73 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Keratitis	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Ocular vascular disorder	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Visual impairment	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0016 affected146 at risk EG0022 affected73 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0022 affected73 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Gastric varices	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0021 affected73 at risk EG003
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0022 affected73 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0014 affected146 at risk EG0020 affected73 at risk EG003
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0021 affected73 at risk EG003
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Disease progression	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
General physical health deterioration	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0014 affected146 at risk EG0021 affected73 at risk EG003
Generalised oedema	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Inflammation	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Multi-organ failure	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Oedema peripheral	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Performance status decreased	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG0015 affected146 at risk EG0021 affected73 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Portal hypertension	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0021 affected73 at risk EG003
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0014 affected146 at risk EG0021 affected73 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Campylobacter infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Cellulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Cystitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Endocarditis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Enterococcal sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Escherichia infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Febrile infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Gastroenteritis clostridial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Genital infection female	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Influenza	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Klebsiella sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Lung infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Meningitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Meningoencephalitis herpetic	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Oesophageal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Peritonitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG00111 affected146 at risk EG0024 affected73 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Postoperative abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pseudomonal sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Septic shock	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Skin infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Testicular abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Tuberculosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Urosepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Viral infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Ear injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Postoperative respiratory distress	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Blood creatinine increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
C-reactive protein increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Weight increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0014 affected146 at risk EG0020 affected73 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Lung adenocarcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0021 affected73 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0014 affected146 at risk EG0020 affected73 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0015 affected146 at risk EG0021 affected73 at risk EG003
Aphasia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0014 affected146 at risk EG0020 affected73 at risk EG003
Coma	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Convulsion	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pseudoradicular syndrome	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Somnolence	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Delusion	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Prerenal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0014 affected146 at risk EG0021 affected73 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Renal infarct	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0014 affected146 at risk EG0023 affected73 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0021 affected73 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0014 affected146 at risk EG0020 affected73 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0022 affected73 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0022 affected73 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Aortic thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0021 affected73 at risk EG003
Arterial stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Intra-abdominal haematoma	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003
Thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0020 affected73 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0011 affected146 at risk EG0020 affected73 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00061 affected146 at risk EG00171 affected146 at risk EG0028 affected73 at risk EG00319 affected45 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected146 at risk EG0018 affected146 at risk EG0020 affected73 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG00067 affected146 at risk EG00177 affected146 at risk EG00210 affected73 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected146 at risk EG0018 affected146 at risk EG0021 affected73 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG00111 affected146 at risk EG0021 affected73 at risk EG003
Palpitations	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected146 at risk EG00112 affected146 at risk EG0020 affected73 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG0018 affected146 at risk EG0024 affected73 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected146 at risk EG0019 affected146 at risk EG0021 affected73 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected146 at risk EG00111 affected146 at risk EG0023 affected73 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00014 affected146 at risk EG00121 affected146 at risk EG00212 affected73 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00012 affected146 at risk EG00116 affected146 at risk EG0024 affected73 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG0016 affected146 at risk EG0023 affected73 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00012 affected146 at risk EG00119 affected146 at risk EG0023 affected73 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00036 affected146 at risk EG00155 affected146 at risk EG00213 affected73 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected146 at risk EG00110 affected146 at risk EG0024 affected73 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG00110 affected146 at risk EG0020 affected73 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00021 affected146 at risk EG00130 affected146 at risk EG0027 affected73 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG00016 affected146 at risk EG00127 affected146 at risk EG0021 affected73 at risk EG003
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG00028 affected146 at risk EG00138 affected146 at risk EG0029 affected73 at risk EG003
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected146 at risk EG0010 affected146 at risk EG0024 affected73 at risk EG003
Chills	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG0018 affected146 at risk EG0020 affected73 at risk EG003
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG00023 affected146 at risk EG00136 affected146 at risk EG0028 affected73 at risk EG003
General physical health deterioration	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0017 affected146 at risk EG0024 affected73 at risk EG003
Oedema peripheral	General disorders	MedDRA 17.1	Systematic Assessment	EG00033 affected146 at risk EG00155 affected146 at risk EG00221 affected73 at risk EG003
Peripheral swelling	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0017 affected146 at risk EG0020 affected73 at risk EG003
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG00020 affected146 at risk EG00136 affected146 at risk EG0026 affected73 at risk EG003
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00015 affected146 at risk EG00137 affected146 at risk EG0025 affected73 at risk EG003
Cystitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0009 affected146 at risk EG00115 affected146 at risk EG0023 affected73 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0009 affected146 at risk EG00114 affected146 at risk EG0021 affected73 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0009 affected146 at risk EG00116 affected146 at risk EG0020 affected73 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0012 affected146 at risk EG0020 affected73 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00027 affected146 at risk EG00140 affected146 at risk EG0029 affected73 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0006 affected146 at risk EG0019 affected146 at risk EG0023 affected73 at risk EG003
Rhinitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0007 affected146 at risk EG0019 affected146 at risk EG0020 affected73 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0006 affected146 at risk EG0019 affected146 at risk EG0021 affected73 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG00011 affected146 at risk EG00119 affected146 at risk EG0022 affected73 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG0018 affected146 at risk EG0021 affected73 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0013 affected146 at risk EG0020 affected73 at risk EG003
Cardiac murmur	Investigations	MedDRA 17.1	Systematic Assessment	EG0006 affected146 at risk EG0018 affected146 at risk EG0023 affected73 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0007 affected146 at risk EG00111 affected146 at risk EG0021 affected73 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG0016 affected146 at risk EG0023 affected73 at risk EG003
Platelet count decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG00011 affected146 at risk EG00112 affected146 at risk EG0022 affected73 at risk EG003
Weight decreased	Investigations	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0018 affected146 at risk EG0026 affected73 at risk EG003
Weight increased	Investigations	MedDRA 17.1	Systematic Assessment	EG00023 affected146 at risk EG00129 affected146 at risk EG0021 affected73 at risk EG003
White blood cell count increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0014 affected146 at risk EG0020 affected73 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0006 affected146 at risk EG00120 affected146 at risk EG0024 affected73 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0016 affected146 at risk EG0021 affected73 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0018 affected146 at risk EG0021 affected73 at risk EG003
Iron overload	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0015 affected146 at risk EG0020 affected73 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00019 affected146 at risk EG00130 affected146 at risk EG0028 affected73 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00018 affected146 at risk EG00124 affected146 at risk EG00210 affected73 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected146 at risk EG0019 affected146 at risk EG0024 affected73 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00015 affected146 at risk EG00128 affected146 at risk EG0025 affected73 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG0018 affected146 at risk EG0021 affected73 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0007 affected146 at risk EG00111 affected146 at risk EG0021 affected73 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0019 affected146 at risk EG0021 affected73 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG00018 affected146 at risk EG00124 affected146 at risk EG0024 affected73 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0005 affected146 at risk EG00111 affected146 at risk EG0021 affected73 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG00110 affected146 at risk EG0021 affected73 at risk EG003
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00012 affected146 at risk EG00120 affected146 at risk EG0025 affected73 at risk EG003
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00018 affected146 at risk EG00123 affected146 at risk EG0024 affected73 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG00010 affected146 at risk EG00116 affected146 at risk EG0024 affected73 at risk EG003
Sciatica	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected146 at risk EG0019 affected146 at risk EG0021 affected73 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0005 affected146 at risk EG0019 affected146 at risk EG0020 affected73 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected146 at risk EG00113 affected146 at risk EG0027 affected73 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00022 affected146 at risk EG00138 affected146 at risk EG00212 affected73 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00022 affected146 at risk EG00135 affected146 at risk EG00213 affected73 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00011 affected146 at risk EG00113 affected146 at risk EG0022 affected73 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG00013 affected146 at risk EG00118 affected146 at risk EG0025 affected73 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected146 at risk EG0018 affected146 at risk EG0023 affected73 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0006 affected146 at risk EG0018 affected146 at risk EG0021 affected73 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG0018 affected146 at risk EG0020 affected73 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected146 at risk EG0013 affected146 at risk EG0024 affected73 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected146 at risk EG00111 affected146 at risk EG0020 affected73 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG00014 affected146 at risk EG00127 affected146 at risk EG0026 affected73 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0009 affected146 at risk EG00117 affected146 at risk EG00213 affected73 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected146 at risk EG00112 affected146 at risk EG0021 affected73 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG0014 affected146 at risk EG0021 affected73 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected146 at risk EG00112 affected146 at risk EG0020 affected73 at risk EG003
Haematoma	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG00015 affected146 at risk EG00122 affected146 at risk EG0023 affected73 at risk EG003
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0008 affected146 at risk EG00119 affected146 at risk EG0023 affected73 at risk EG003

ID	Term
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Title	Description
BG000	Ruxolitinib	5 milligram tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
BG001	Best Available Therapy (BAT)	Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ruxolitinib Randomized	Ruxolitinib Randomized	51	146	145	146
EG001	Ruxolitinib Randomized + Extension Phase	Ruxolitinib Randomized + Extension Phase	85	146	145	146
EG002	BAT Randomized	BAT Randomized	22	73	64	73
EG003	Ruxolitinib Cross-over	Ruxolitinib cross-over	20	45	42	45