Orantinib In Combination With Transcatheter Arterial Chem... | NCT01465464

Label	Type	Description	Intervention Names
Orantinib	Experimental		Drug: Orantinib (TSU-68)
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Orantinib (TSU-68)	Drug	200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.	Orantinib

Measure	Description	Time Frame
Overall Survival(OS)		The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient

Measure	Description	Time Frame
Time to Transcatheter Arterial Chemoembolization (TACE) Failure	Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion. The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE Deterioration in arterial pathways to treat HCC that makes additional TACE impossible Severe vascular invasion occurs that makes additional TACE impossible Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC Liver function at grade Child-Pugh class C lasting for 28 days

Name	Affiliation	Role
Taiho Pharmaceutical Co., Ltd.	Taiho Pharmaceutical Co., Ltd.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Ōsaka-sayama	Osaka	589-8511	Japan
Local Institution

PubMed Identifier	Type	Citation	Retractions
28988687	Derived	Kudo M, Cheng AL, Park JW, Park JH, Liang PC, Hidaka H, Izumi N, Heo J, Lee YJ, Sheen IS, Chiu CF, Arioka H, Morita S, Arai Y. Orantinib versus placebo combined with transcatheter arterial chemoembolisation in patients with unresectable hepatocellular carcinoma (ORIENTAL): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):37-46. doi: 10.1016/S2468-1253(17)30290-X. Epub 2017 Oct 4.

ID	Title	Description
FG000	Orantinib	Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
FG001	Placebo	Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.

ID	Title	Description
BG000	Orantinib	Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
BG001	Placebo	Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000444 BG001444 BG002888

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival(OS)

When approximately 50% of the targeted number of time to TACE discontinuation events were confirmed, interim analysis was performed by IDMC.

Because the Committee considered that significant results would no longer be obtained, the IDMC recommended to the Sponsor that the clinical trial would be discontinued, and the Sponsor stopped this trial.

Posted

Median

95% Confidence Interval

days

The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient

ID	Title	Description
OG000	Orantinib	Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
OG001	Placebo	Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.

Units	Counts
Participants	OG000168 OG001163

Title

Denominators

Categories

Title	Measurements
	OG000946.0(807.0 to 1050.0) OG001984.0(864.0 to NA)The upper limit of median OS didn't reach.

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
OG001		Log Rank		0.435		Hazard Ratio (HR)	1.090			2-Sided	95	0.878	1.352					Superiority

Secondary

Time to Transcatheter Arterial Chemoembolization (TACE) Failure

Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion.

The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE
Deterioration in arterial pathways to treat HCC that makes additional TACE impossible
Severe vascular invasion occurs that makes additional TACE impossible
Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC
Liver function at grade Child-Pugh class C lasting for 28 days

When approximately 50% of the targeted number of time to TACE discontinuation events were confirmed, interim analysis was performed by IDMC.

Posted

Median

95% Confidence Interval

days

The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient

ID	Title	Description
OG000	Orantinib	Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
OG001	Placebo	Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Orantinib	Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.	33	444	200	444	443	444
EG001	Placebo	Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.	24	444	134	444	436	444

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0010 affected444 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Leukocytosis	Blood and lymphatic system disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Idiopathic thrombocytopenic purpura	Blood and lymphatic system disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Acute pericarditis	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Angina pectoris	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Atrial thrombosis	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Cardiopulmonary arrest	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Heart failure	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Left ventricular dysfunction	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Myocardial infarction	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0010 affected444 at risk
Paroxysmal supraventricular tachycardia	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Pericardial effusion	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Acute myocardial infarction	Cardiac disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Hydrocele cord	Congenital, familial and genetic disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Hypothyroidism	Endocrine disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Cataract	Eye disorders	CTCAE, version 4.02	Systematic Assessment	EG0004 affected444 at risk EG0013 affected444 at risk
Cataract aggravated	Eye disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0011 affected444 at risk
Diabetic retinopathy	Eye disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Retinal macroaneurysm	Eye disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0009 affected444 at risk EG0017 affected444 at risk
Acute pancreatitis	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Anal fistula	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Acute gastric ulcer with haemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Ascites	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00019 affected444 at risk EG00111 affected444 at risk
Colonic polyp	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Dental caries	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Diarrhea	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0004 affected444 at risk EG0012 affected444 at risk
Duodenal ulcer	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Duodenal ulcer hemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Epigastric pain	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Esophageal hemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Esophageal varices hemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0006 affected444 at risk EG0017 affected444 at risk
Enterocolitis	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Gastric varices bleeding	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Gastric varices haemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0017 affected444 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Gastroesophageal varices hemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Gastric perforation	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0012 affected444 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Inguinal hernia	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0012 affected444 at risk
Irritable bowel syndrome	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Ischemia bowel	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Ischemic enterocolitis	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Large intestine polyp	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Melaena	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Hematemesis	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Intestinal obstruction	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Mouth haemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Nausea	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0006 affected444 at risk EG0017 affected444 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Periodontal disease	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Right upper quadrant pain	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Ulcer duodenal haemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Varices oesophageal	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0016 affected444 at risk
Vomiting	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0010 affected444 at risk
Condition aggravated	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Disease progression	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Edema limbs	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0011 affected444 at risk
Fever	General disorders	CTCAE, version 4.02	Systematic Assessment	EG00013 affected444 at risk EG00111 affected444 at risk
Gait disturbance	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Malaise	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0010 affected444 at risk
Multi organ failure	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Pain	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Weakness generalised	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0005 affected444 at risk EG0010 affected444 at risk
Fatigue	General disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0012 affected444 at risk
Acute cholecystitis	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Acute hepatic failure	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0011 affected444 at risk
Bile duct stenosis	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0015 affected444 at risk
Biliary fistula	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Biloma	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0005 affected444 at risk EG0011 affected444 at risk
Cholangitis	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0005 affected444 at risk EG0012 affected444 at risk
Cholangitis acute	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0012 affected444 at risk
Cholecystitis	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0014 affected444 at risk
Dilatation intrahepatic duct acquired	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Gallbladder perforation	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Haemobilia	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0012 affected444 at risk
Hepatic failure	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG00016 affected444 at risk EG00111 affected444 at risk
Hepatic function disorder	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG00011 affected444 at risk EG0014 affected444 at risk
Hepatic necrosis	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Hepatopathy	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0012 affected444 at risk
Hyperbilirubinemia	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0012 affected444 at risk
Jaundice	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0012 affected444 at risk
Obstructive jaundice	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Portal vein thrombosis	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0012 affected444 at risk
Hepatic vein thrombosis	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Hepatorenal syndrome	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0006 affected444 at risk EG0010 affected444 at risk
Contrast media allergy	Immune system disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Acute bronchitis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Acute gastroenteritis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Acute pyelonephritis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Appendicitis perforated	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0011 affected444 at risk
Bacteremia	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0013 affected444 at risk
Biliary tract infection	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0013 affected444 at risk
Bronchopneumonia	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Cellulitis of foot	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Cryptococcal pneumonitis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Cystitis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Enteritis infectious	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Hepatic infection bacterial	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Herpes zoster	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0012 affected444 at risk
Infectious colitis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Intra-abdominal infection	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0010 affected444 at risk
Liver abscess	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG00034 affected444 at risk EG0013 affected444 at risk
Otitis media chronic	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Periodontal abscess	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Pneumonia	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0005 affected444 at risk EG0011 affected444 at risk
Pulpitis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Rectal abscess	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Sepsis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0006 affected444 at risk EG0014 affected444 at risk
Spontaneous bacterial peritonitis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0005 affected444 at risk EG0010 affected444 at risk
Tuberculous pleurisy	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
UTI	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Upper respiratory infection	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Urinary tract infection	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0012 affected444 at risk
Pyelonephritis	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Compression fracture	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Fall	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Fracture of lateral malleolus, closed	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0013 affected444 at risk
Humerus fracture	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Maternal exposure during pregnancy	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Nerve injury	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Polytraumatism	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Post embolization syndrome	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0010 affected444 at risk
Ankle fracture	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0012 affected444 at risk
Traffic accident	Injury, poisoning and procedural complications	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
ALT increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0011 affected444 at risk
AST increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0011 affected444 at risk
Blood bilirubin increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0012 affected444 at risk
CRP increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Creatinine increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0011 affected444 at risk
Elevated liver enzymes	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Liver biopsy	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Spleen scan abnormal	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Platelet count decreased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
WBC decreased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0011 affected444 at risk
Diabetes mellitus aggravated	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0012 affected444 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Gout aggravated	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Hypercalcaemia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0014 affected444 at risk
Hyperkalemia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Hypoglycaemia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Hypokalaemia	Investigations	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0011 affected444 at risk
Inappetence	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Inappetence	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Tumor lysis syndrome	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0012 affected444 at risk
Arthritis	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0012 affected444 at risk
Cervical disc herniation	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Pain in thigh	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Pseudogout	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0011 affected444 at risk
Wrist pain	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Avascular necrosis femoral head	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Bone metastases	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0008 affected444 at risk EG0013 affected444 at risk
Brain metastases	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Cancer of descending colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0012 affected444 at risk
Hemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Hepatocellular carcinoma non-resectable	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0015 affected444 at risk
Hepatoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Liver carcinoma ruptured	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0016 affected444 at risk
Lung metastases	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Spinal metastases	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Tumor necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Tumor rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Adenocarcinoma of the gastrooesophageal junction	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Benign neoplasm of spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0014 affected444 at risk
Cecal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Inverting papilloma of the nasal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Malignant neoplasm of cheek mucosa	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0012 affected444 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Tumour embolism	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Cerebral infarction	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG0005 affected444 at risk EG0015 affected444 at risk
Hepatic encephalopathy	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG00012 affected444 at risk EG0016 affected444 at risk
Intracranial hemorrhage	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0011 affected444 at risk
Numbness of lower extremities	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Spinal cord compression	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Syncope	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Dizziness	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Delirium	Psychiatric disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Orientation disturbed	Psychiatric disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Acute kidney injury	Renal and urinary disorders	CTCAE, version 4.02	Systematic Assessment	EG0004 affected444 at risk EG0013 affected444 at risk
Renal failure	Renal and urinary disorders	CTCAE, version 4.02	Systematic Assessment	EG0004 affected444 at risk EG0014 affected444 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Aspiration pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Chronic cough	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0011 affected444 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0002 affected444 at risk EG0010 affected444 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0007 affected444 at risk EG0012 affected444 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0011 affected444 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Shortness of breath	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Gastrooesophageal variceal haemorrhage prophylaxis	Surgical and medical procedures	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0010 affected444 at risk
Induced abortion	Surgical and medical procedures	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Oesophageal variceal ligation	Surgical and medical procedures	CTCAE, version 4.02	Systematic Assessment	EG0003 affected444 at risk EG0015 affected444 at risk
Varicose vein ruptured	Vascular disorders	CTCAE, version 4.02	Systematic Assessment	EG0001 affected444 at risk EG0010 affected444 at risk
Abdominal aortic aneurysm	Vascular disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Arterial stenosis	Vascular disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Deep vein thrombosis	Vascular disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Obstructive arteriosclerosis of lower extremities	Vascular disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk
Vascular disorder	Vascular disorders	CTCAE, version 4.02	Systematic Assessment	EG0000 affected444 at risk EG0011 affected444 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	CTCAE, version 4.02	Systematic Assessment	EG00054 affected444 at risk EG00132 affected444 at risk
Abdominal distension	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00050 affected444 at risk EG00153 affected444 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG000317 affected444 at risk EG001292 affected444 at risk
Abdominal pain upper	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00056 affected444 at risk EG00146 affected444 at risk
Ascites	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG000140 affected444 at risk EG00173 affected444 at risk
Constipation	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG000179 affected444 at risk EG001147 affected444 at risk
Diarrhoea	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG000123 affected444 at risk EG00170 affected444 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00051 affected444 at risk EG00147 affected444 at risk
Gastritis	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00023 affected444 at risk EG00129 affected444 at risk
Gastrointestinal pain	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00022 affected444 at risk EG00114 affected444 at risk
Nausea	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG000179 affected444 at risk EG001179 affected444 at risk
Vomiting	Gastrointestinal disorders	CTCAE, version 4.02	Systematic Assessment	EG000126 affected444 at risk EG001116 affected444 at risk
Chills	General disorders	CTCAE, version 4.02	Systematic Assessment	EG00034 affected444 at risk EG00123 affected444 at risk
Face oedema	General disorders	CTCAE, version 4.02	Systematic Assessment	EG000138 affected444 at risk EG0018 affected444 at risk
Fatigue	General disorders	CTCAE, version 4.02	Systematic Assessment	EG000101 affected444 at risk EG00192 affected444 at risk
Malaise	General disorders	CTCAE, version 4.02	Systematic Assessment	EG000101 affected444 at risk EG00186 affected444 at risk
Non-cardiac chest pain	General disorders	CTCAE, version 4.02	Systematic Assessment	EG00032 affected444 at risk EG00125 affected444 at risk
Oedema peripheral	General disorders	CTCAE, version 4.02	Systematic Assessment	EG000130 affected444 at risk EG00159 affected444 at risk
Pyrexia	General disorders	CTCAE, version 4.02	Systematic Assessment	EG000264 affected444 at risk EG001284 affected444 at risk
Hepatic failure	Hepatobiliary disorders	CTCAE, version 4.02	Systematic Assessment	EG00024 affected444 at risk EG00120 affected444 at risk
Liver abscess	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG00030 affected444 at risk EG0013 affected444 at risk
Upper respiratory tract infection	Infections and infestations	CTCAE, version 4.02	Systematic Assessment	EG00086 affected444 at risk EG00185 affected444 at risk
ALT increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG000200 affected444 at risk EG001170 affected444 at risk
AST increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG000223 affected444 at risk EG001189 affected444 at risk
ALP increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG00064 affected444 at risk EG00122 affected444 at risk
Bilirubin increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG00077 affected444 at risk EG00175 affected444 at risk
CRP increased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG00047 affected444 at risk EG00144 affected444 at risk
Lymphocyte count decreased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG00040 affected444 at risk EG00145 affected444 at risk
Platelet count decreased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG00053 affected444 at risk EG00148 affected444 at risk
Weight decreased	Investigations	CTCAE, version 4.02	Systematic Assessment	EG00031 affected444 at risk EG00120 affected444 at risk
Decreased appetite	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG000209 affected444 at risk EG001149 affected444 at risk
Hyperkalaemia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG00023 affected444 at risk EG00114 affected444 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG00098 affected444 at risk EG00185 affected444 at risk
Hypokalaemia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG00034 affected444 at risk EG00116 affected444 at risk
Hyponatraemia	Metabolism and nutrition disorders	CTCAE, version 4.02	Systematic Assessment	EG00031 affected444 at risk EG00122 affected444 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG00034 affected444 at risk EG00119 affected444 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG00090 affected444 at risk EG00194 affected444 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG00038 affected444 at risk EG00136 affected444 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG00032 affected444 at risk EG00122 affected444 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG00040 affected444 at risk EG00130 affected444 at risk
Dizziness	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG00038 affected444 at risk EG00135 affected444 at risk
Headache	Nervous system disorders	CTCAE, version 4.02	Systematic Assessment	EG00074 affected444 at risk EG00162 affected444 at risk
Insomnia	Psychiatric disorders	CTCAE, version 4.02	Systematic Assessment	EG00079 affected444 at risk EG00168 affected444 at risk
Chromaturia	Renal and urinary disorders	CTCAE, version 4.02	Systematic Assessment	EG000103 affected444 at risk EG00118 affected444 at risk
Proteinuria	Renal and urinary disorders	CTCAE, version 4.02	Systematic Assessment	EG00047 affected444 at risk EG00117 affected444 at risk
Hypertension	Vascular disorders	CTCAE, version 4.02	Systematic Assessment	EG00059 affected444 at risk EG00157 affected444 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00069 affected444 at risk EG00168 affected444 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00029 affected444 at risk EG00130 affected444 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE, version 4.02	Systematic Assessment	EG00036 affected444 at risk EG00116 affected444 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE, version 4.02	Systematic Assessment	EG00043 affected444 at risk EG00151 affected444 at risk

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases