Study Comparing Bevacizumab + Temsirolimus vs. Bevacizuma... | NCT00631371

NCT00631371

ID	Type	Description	Link
B1771006	Other Identifier	Alias Study Number
2007-003793-26	EudraCT Number

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
1	Experimental	Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly	Drug: Bevacizumab Drug: Temsirolimus
2	Active Comparator	Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW	Drug: Bevacizumab Drug: Interferon-Alfa 9MU

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Bevacizumab 10 mg/kg intravenous (IV) q8wks	1	Torisel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS): Independent-Assessment	PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.	Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS): Investigator-Assessment	PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hematology Oncology Services of Arkansas		Little Rock	Arkansas	72205	United States
South County Hematology/Oncology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37146227	Derived	Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
28410911

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bevacizumab+Temsirolimus	Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Bevacizumab+Temsirolimus	Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
BG001	Bevacizumab+ Interferon-Alfa	Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
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
	OG0009.1(8.1 to 10.2) OG0019.3(9.0 to 11.2)

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	P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy [yes/no] and Memorial Sloan Kettering Cancer Center [MSKCC] risk factors [good/intermediate/poor] at time of randomization). The hazard ratio and corresponding 95 percent (%) confidence interval (CI) from the stratified cox proportional hazard model were also presented.	Log Rank		0.8		Hazard Ratio (HR)	1.1			2-Sided	95	0.9	1.3				No	Superiority or Other

Secondary

Progression-Free Survival (PFS): Investigator-Assessment

PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.

ITT population included all participants who were randomized to the study.

Posted

Median

95% Confidence Interval

months

Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

ID	Title	Description
OG000	Bevacizumab+Temsirolimus	Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
OG001	Bevacizumab+ Interferon-Alfa	Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.

Secondary

Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

ITT population included all participants who were randomized to the study.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)

ID	Title	Description
OG000	Bevacizumab+Temsirolimus	Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
OG001	Bevacizumab+ Interferon-Alfa	Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.

Secondary

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

ITT population included all participants who were randomized to the study.

Posted

Median

95% Confidence Interval

months

Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)

ID	Title	Description
OG000	Bevacizumab+Temsirolimus	Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
OG001	Bevacizumab+ Interferon-Alfa	Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.

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	Bevacizumab+Temsirolimus	Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.			184	393	383	393
EG001	Bevacizumab+ Interferon-Alfa	Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant's tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.			158	391	378	391

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG00010 affected393 at risk EG00112 affected391 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0010 affected391 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Retinopathy	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0012 affected391 at risk
Vitreous floaters	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0008 affected393 at risk EG0016 affected391 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0012 affected391 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Ascites	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0007 affected393 at risk EG0015 affected391 at risk
Gastric fistula	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Ileus	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0011 affected391 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Painful defaecation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0012 affected391 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Proctitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Subileus	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0012 affected391 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0007 affected393 at risk EG0012 affected391 at risk
Asthenia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG0015 affected391 at risk
Chills	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Death	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0014 affected391 at risk
Disease progression	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00013 affected393 at risk EG00116 affected391 at risk
Fatigue	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0017 affected391 at risk
General physical health deterioration	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0016 affected391 at risk
Injury associated with device	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Mucosal inflammation	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected393 at risk EG0010 affected391 at risk
Multi-organ failure	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0012 affected391 at risk
Pyrexia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0009 affected393 at risk EG0017 affected391 at risk
Sudden death	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected393 at risk EG0010 affected391 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0010 affected391 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Contrast media allergy	Immune system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Abdominal abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Abscess intestinal	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Anal abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0005 affected393 at risk EG0012 affected391 at risk
Anorectal cellulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Appendicitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Bronchopneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0011 affected391 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Cystitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Erysipelas	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Gangrene	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Haematoma infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Haemorrhoid infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Injection site infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Liver abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Lung abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Perirectal abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Peritoneal abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Peritonitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0012 affected391 at risk
Pharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG00016 affected393 at risk EG0015 affected391 at risk
Post procedural infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Rectal abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0011 affected391 at risk
Scrotal abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0014 affected391 at risk
Septic shock	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0012 affected391 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Tooth infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0005 affected393 at risk EG0014 affected391 at risk
Urosepsis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Viral infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Viral pharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0012 affected391 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Blood pressure systolic decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Fibrin D dimer increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Haemoglobin decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0012 affected391 at risk
Protein urine present	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Weight decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG0013 affected391 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Gout	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0012 affected391 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG0010 affected391 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0013 affected391 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0012 affected391 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Ketosis	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0011 affected391 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0013 affected391 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0012 affected391 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0011 affected391 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG0011 affected391 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Tumour ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Brain stem infarction	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0012 affected391 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0013 affected391 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Epilepsy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Facial paresis	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0012 affected391 at risk
Headache	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG0012 affected391 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Mental impairment	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Somnolence	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Spinal cord compression	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0014 affected391 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0014 affected391 at risk
Tremor	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Confusional state	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0013 affected391 at risk
Nephrectasia	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG0012 affected391 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0013 affected391 at risk
Renal disorder	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected393 at risk EG0012 affected391 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Ureteral disorder	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG00110 affected391 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0012 affected391 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0013 affected391 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0010 affected391 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Nasal septum disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0012 affected391 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0012 affected391 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG0010 affected391 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected393 at risk EG0014 affected391 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0011 affected391 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Malignant tumour excision	Surgical and medical procedures	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Arteriosclerosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Circulatory collapse	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected393 at risk EG0011 affected391 at risk
Haematoma	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Haemorrhage	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0006 affected393 at risk EG0014 affected391 at risk
Hypertensive crisis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0011 affected391 at risk
Lymphoedema	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Venous thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Condition Aggravated	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Colonic abscess	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Epididymitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Plasmodium Malariae Infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Blood Bilirubin Increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Blood Creatinine Increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Balance Disorder	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Central Nervous System Haemorrhage	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Seizure	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected393 at risk EG0011 affected391 at risk
Toxic Encephalopathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Vascular Encephalopathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Completed Suicide	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected393 at risk EG0011 affected391 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG0013 affected391 at risk
Cancer Surgery	Surgical and medical procedures	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk
Peripheral Venous Disease	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected393 at risk EG0010 affected391 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG00080 affected393 at risk EG00166 affected391 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG00017 affected393 at risk EG00140 affected391 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG00024 affected393 at risk EG00138 affected391 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG00018 affected393 at risk EG00166 affected391 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG00050 affected393 at risk EG00140 affected391 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00048 affected393 at risk EG00142 affected391 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00031 affected393 at risk EG00121 affected391 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00043 affected393 at risk EG00148 affected391 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG000126 affected393 at risk EG00186 affected391 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0005 affected393 at risk EG00121 affected391 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00028 affected393 at risk EG00113 affected391 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00069 affected393 at risk EG00178 affected391 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG000102 affected393 at risk EG00139 affected391 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00037 affected393 at risk EG00114 affected391 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00053 affected393 at risk EG00153 affected391 at risk
Asthenia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00095 affected393 at risk EG001113 affected391 at risk
Chills	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00015 affected393 at risk EG00144 affected391 at risk
Fatigue	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00092 affected393 at risk EG001122 affected391 at risk
Influenza like illness	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00014 affected393 at risk EG00148 affected391 at risk
Mucosal inflammation	General disorders	MedDRA 18.0	Non-systematic Assessment	EG000105 affected393 at risk EG00140 affected391 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00067 affected393 at risk EG00132 affected391 at risk
Pyrexia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00079 affected393 at risk EG001154 affected391 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG00020 affected393 at risk EG00115 affected391 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG00023 affected393 at risk EG00121 affected391 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG00038 affected393 at risk EG00135 affected391 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG00033 affected393 at risk EG00141 affected391 at risk
Blood creatinine increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG00040 affected393 at risk EG00125 affected391 at risk
Weight decreased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG00090 affected393 at risk EG00193 affected391 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG000103 affected393 at risk EG001127 affected391 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG000126 affected393 at risk EG00139 affected391 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG00086 affected393 at risk EG00119 affected391 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG00029 affected393 at risk EG00137 affected391 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG000114 affected393 at risk EG00182 affected391 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG00024 affected393 at risk EG00113 affected391 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG00020 affected393 at risk EG00116 affected391 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG00023 affected393 at risk EG00121 affected391 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG00040 affected393 at risk EG00118 affected391 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00052 affected393 at risk EG00149 affected391 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00047 affected393 at risk EG00153 affected391 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00018 affected393 at risk EG00122 affected391 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00027 affected393 at risk EG00119 affected391 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00014 affected393 at risk EG00128 affected391 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00019 affected393 at risk EG00160 affected391 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00043 affected393 at risk EG00135 affected391 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG00029 affected393 at risk EG00137 affected391 at risk
Dysgeusia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG00033 affected393 at risk EG00121 affected391 at risk
Headache	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG00077 affected393 at risk EG00182 affected391 at risk
Anxiety	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0007 affected393 at risk EG00121 affected391 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG00011 affected393 at risk EG00122 affected391 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG00028 affected393 at risk EG00131 affected391 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG000143 affected393 at risk EG001111 affected391 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00079 affected393 at risk EG00170 affected391 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00013 affected393 at risk EG00130 affected391 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00036 affected393 at risk EG00149 affected391 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG000110 affected393 at risk EG00182 affected391 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG00028 affected393 at risk EG00116 affected391 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00027 affected393 at risk EG00113 affected391 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG00060 affected393 at risk EG00126 affected391 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG000126 affected393 at risk EG00132 affected391 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG000128 affected393 at risk EG001102 affected391 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected393 at risk EG00120 affected391 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG00020 affected393 at risk EG00114 affected391 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG00020 affected393 at risk EG0014 affected391 at risk

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D014571	Urologic Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Term
D002292	Carcinoma, Renal Cell
D007680	Kidney Neoplasms
D014565	Urogenital Neoplasms