A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A An... | NCT00617669

NCT00617669

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo + Docetaxel	Active Comparator	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks	Drug: Docetaxel Drug: Placebo
ZD4054 + Docetaxel	Experimental	ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks	Drug: Docetaxel Drug: ZD4054

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel	Drug	intravenous infusion given every three weeks	Placebo + Docetaxel ZD4054 + Docetaxel

Outcomes Module

Measure	Description	Time Frame
Overall Survival	Median time (in months) from randomisation until death using the Kaplan-Meier method.	Patients were followed for survival up to 40 months

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival	Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline	Patients were followed for progression up to 40 months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Karim Fizazi, MD, PhD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator
Judd W Moul, MD, FACS	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Greenbrae	California		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23569308	Derived	Fizazi K, Higano CS, Nelson JB, Gleave M, Miller K, Morris T, Nathan FE, McIntosh S, Pemberton K, Moul JW. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013 May 10;31(14):1740-7. doi: 10.1200/JCO.2012.46.4149. Epub 2013 Apr 8.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
FG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
BG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00020.0(11.6 to 32.0) OG00119.2(12.0 to 30.3)

Secondary

Progression Free Survival

Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline

Full Analysis Set

Posted

Median

Inter-Quartile Range

Months

Patients were followed for progression up to 40 months

ID	Title	Description
OG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
OG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Units	Counts
Participants	OG000

Secondary

Incidence of Skeletal Related Events

Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression.

Full Analysis Set

Posted

Median

Inter-Quartile Range

Months

While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

ID	Title	Description
OG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
OG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Units	Counts
Participants

Secondary

Time to Prostate-specific Antigen (PSA) Progression

Median time (in months) from randomisation until first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.

Posted

Median

Inter-Quartile Range

Months

While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

ID	Title	Description
OG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
OG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Units	Counts
Participants	OG000

Secondary

Time to Pain Progression

Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.

Full Analysis Set

Posted

Median

Inter-Quartile Range

Months

While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

ID	Title	Description
OG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
OG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Units	Counts
Participants

Secondary

Pain Response

Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.

The Pain Response Analysis Set includes patients who were either receiving opiates at baseline (randomisation) or with a baseline BPI score ≥2.

Posted

Number

Participants

While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

ID	Title	Description
OG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
OG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Units	Counts
Participants	OG000

Secondary

Health Related Quality of Life

Median time (in months) from randomisation until deterioration of Health Related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.

Full Analysis Set

Posted

Median

Inter-Quartile Range

Months

While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

ID	Title	Description
OG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
OG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Units	Counts
Participants	OG000

Secondary

PSA Response

PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.

Full Analysis Set

Posted

Number

Participants

While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

ID	Title	Description
OG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
OG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ZD4054 + Docetaxel	XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks			214	522	490	522
EG001	Placebo + Docetaxel	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks			203	525	483	525

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG00022 affected522 at risk EG00116 affected525 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG00019 affected522 at risk EG0018 affected525 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG00010 affected522 at risk EG00112 affected525 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0014 affected525 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Lymphatic Obstruction	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected522 at risk EG0012 affected525 at risk
Cardiac Failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0005 affected522 at risk EG0012 affected525 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected522 at risk EG0014 affected525 at risk
Angina Pectoris	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0012 affected525 at risk
Atrial Flutter	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0012 affected525 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Angina Unstable	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Aortic Valve Disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Arrhythmia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Bradycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Diastolic Dysfunction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Hypertrophic Cardiomyopathy	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Adrenal Insufficiency	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Adrenocortical Insufficiency Acute	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Inappropriate Antidiuretic Hormone Secretion	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Cataract	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Scleral Disorder	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Staphyloma	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Visual Acuity Reduced	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected522 at risk EG0015 affected525 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected522 at risk EG0013 affected525 at risk
Ileus	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0013 affected525 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0011 affected525 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Colitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Colonic Polyp	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Diarrhoea Haemorrhagic	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Erosive Oesophagitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Gastritis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Inguinal Hernia Strangulated	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Intestinal Infarction	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Irritable Bowel Syndrome	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Large Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Neutropenic Colitis	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Oesophagitis Ulcerative	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Rectourethral Fistula	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected522 at risk EG00112 affected525 at risk
Death	General disorders	MedDRA 14.0	Systematic Assessment	EG00010 affected522 at risk EG0016 affected525 at risk
Oedema Peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected522 at risk EG0013 affected525 at risk
General Physical Health Deterioration	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0013 affected525 at risk
Asthenia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Disease Progression	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Medical Device Complication	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Chest Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Device Occlusion	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Sudden Death	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00026 affected522 at risk EG0018 affected525 at risk
Sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00010 affected522 at risk EG0012 affected525 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0009 affected522 at risk EG0017 affected525 at risk
Urosepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0004 affected522 at risk EG0015 affected525 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0004 affected522 at risk EG0011 affected525 at risk
Neutropenic Sepsis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0004 affected522 at risk EG0013 affected525 at risk
Bronchopneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected522 at risk EG0012 affected525 at risk
Lung Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0003 affected522 at risk EG0010 affected525 at risk
Bronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0011 affected525 at risk
Cystitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0012 affected525 at risk
Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Lobar Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0012 affected525 at risk
Pharyngitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0011 affected525 at risk
Sinusitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Skin Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0011 affected525 at risk
Abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Abscess Limb	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Anal Abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Appendicitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Arthritis Bacterial	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Arthritis Infective	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Bacterial Diarrhoea	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Catheter Site Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Diverticulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Endocarditis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Erysipelas	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Furuncle	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Herpes Zoster	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Labyrinthitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Localised Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Lyme Disease	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Necrotising Fasciitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Neutropenic Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Otitis Media	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Peritonitis Bacterial	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Pneumocystis Jiroveci Pneumonia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Psoas Abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Tooth Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Tracheobronchitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0011 affected525 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Cerebral Haemorrhage Traumatic	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Facial Bones Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Kidney Rupture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Multiple Injuries	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Postoperative Wound Complication	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Radiation Pneumonitis	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Stress Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Haemoglobin Decreased	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Blood Electrolytes Abnormal	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Electrocardiogram QT Prolonged	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Neutrophil Count Decreased	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Transaminases Increased	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0007 affected522 at risk EG0018 affected525 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected522 at risk EG0015 affected525 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected522 at risk EG0013 affected525 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0014 affected525 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Osteonecrosis Of Jaw	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0012 affected525 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Bladder Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Colorectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Gastrointestinal Stromal Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Lentigo Maligna Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Malignant Lymphoid Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected522 at risk EG0011 affected525 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Presyncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Convulsion	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Depressed Level Of Consciousness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Diabetic Neuropathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Encephalopathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Neurotoxicity	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Paraplegia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Radiculopathy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Syncope	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Completed Suicide	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0013 affected525 at risk
Confusional State	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Delirium	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Depression	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0007 affected522 at risk EG0012 affected525 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0014 affected525 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0012 affected525 at risk
Bladder Neck Obstruction	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Bladder Obstruction	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Cystitis Noninfective	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Haemorrhage Urinary Tract	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Postrenal Failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Renal Colic	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Renal Failure	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Renal Tubular Necrosis	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0006 affected522 at risk EG0017 affected525 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0015 affected525 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected522 at risk EG0014 affected525 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0004 affected522 at risk EG0012 affected525 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0011 affected525 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Pleural Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Stevens-Johnson Syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected522 at risk EG0012 affected525 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0010 affected525 at risk
Hypotension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected522 at risk EG0012 affected525 at risk
Jugular Vein Thrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0012 affected525 at risk
Circulatory Collapse	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Haematoma	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk
Hypertension	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
Hypovolaemic Shock	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0011 affected525 at risk
Shock	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected522 at risk EG0010 affected525 at risk
sThrombosis	Vascular disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected522 at risk EG0011 affected525 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG000155 affected522 at risk EG001116 affected525 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG000114 affected522 at risk EG001118 affected525 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00064 affected522 at risk EG00160 affected525 at risk
Lacrimation Increased	Eye disorders	MedDRA 10.0	Systematic Assessment	EG00038 affected522 at risk EG00136 affected525 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000183 affected522 at risk EG001185 affected525 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000174 affected522 at risk EG001160 affected525 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000152 affected522 at risk EG001129 affected525 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG000110 affected522 at risk EG00184 affected525 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00021 affected522 at risk EG00140 affected525 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00032 affected522 at risk EG00135 affected525 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00025 affected522 at risk EG00134 affected525 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00031 affected522 at risk EG00127 affected525 at risk
Oedema Peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG000278 affected522 at risk EG001188 affected525 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG000150 affected522 at risk EG001164 affected525 at risk
Asthenia	General disorders	MedDRA 10.0	Systematic Assessment	EG000118 affected522 at risk EG001117 affected525 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG00059 affected522 at risk EG00160 affected525 at risk
Mucosal Inflammation	General disorders	MedDRA 10.0	Systematic Assessment	EG00037 affected522 at risk EG00128 affected525 at risk
Rhinitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00051 affected522 at risk EG00136 affected525 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00037 affected522 at risk EG00148 affected525 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00030 affected522 at risk EG00136 affected525 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00018 affected522 at risk EG00127 affected525 at risk
Weight Decreased	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00037 affected522 at risk EG00137 affected525 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG000127 affected522 at risk EG001119 affected525 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00029 affected522 at risk EG00117 affected525 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00025 affected522 at risk EG00127 affected525 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00094 affected522 at risk EG00191 affected525 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00080 affected522 at risk EG00186 affected525 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00071 affected522 at risk EG00184 affected525 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00042 affected522 at risk EG00153 affected525 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00046 affected522 at risk EG00128 affected525 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00022 affected522 at risk EG00137 affected525 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00029 affected522 at risk EG00137 affected525 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00028 affected522 at risk EG00132 affected525 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00032 affected522 at risk EG00120 affected525 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG000107 affected522 at risk EG00171 affected525 at risk
Dysgeusia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00088 affected522 at risk EG00173 affected525 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00049 affected522 at risk EG00165 affected525 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00045 affected522 at risk EG00148 affected525 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00043 affected522 at risk EG00145 affected525 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00041 affected522 at risk EG00139 affected525 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00024 affected522 at risk EG00128 affected525 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00071 affected522 at risk EG00159 affected525 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG00030 affected522 at risk EG00117 affected525 at risk
Dysuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG00029 affected522 at risk EG00119 affected525 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00082 affected522 at risk EG00172 affected525 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00058 affected522 at risk EG00178 affected525 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00078 affected522 at risk EG00126 affected525 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00043 affected522 at risk EG00138 affected525 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00026 affected522 at risk EG00131 affected525 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG000178 affected522 at risk EG001196 affected525 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00024 affected522 at risk EG00140 affected525 at risk
Nail Discolouration	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00028 affected522 at risk EG00139 affected525 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00032 affected522 at risk EG00128 affected525 at risk
Nail Disorder	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00023 affected522 at risk EG00128 affected525 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00016 affected522 at risk EG00137 affected525 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00033 affected522 at risk EG00128 affected525 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes