Study Of Sunitinib Malate Versus Sorafenib In Patients Wi... | NCT00699374

NCT00699374

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

Label	Type	Description	Intervention Names
Arm A	Experimental	sunitinib arm	Drug: sunitinib malate
Arm B	Active Comparator	sorafenib arm	Drug: sorafenib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sunitinib malate	Drug	sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.	Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)	The period from randomization until disease progression or death.	Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Time to Tumor Progression (TTP)

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Fountain Valley	California	92708	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35226112	Derived	Abuhelwa AY, Badaoui S, Yuen HY, McKinnon RA, Ruanglertboon W, Shankaran K, Tuteja A, Sorich MJ, Hopkins AM. A clinical scoring tool validated with machine learning for predicting severe hand-foot syndrome from sorafenib in hepatocellular carcinoma. Cancer Chemother Pharmacol. 2022 Apr;89(4):479-485. doi: 10.1007/s00280-022-04411-9. Epub 2022 Feb 28.
24081937

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	Sunitinib	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])

Arm/Group Information

ID	Title	Description
BG000	Sunitinib	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
BG001	Sorafenib	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
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
	OG00034.3(31.9 to 39.9) OG00143.9(38.1 to 48.7)

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		Log Rank		0.9993	One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior transarterial chemoembolization (TACE) and tumor invasion condition.	Hazard Ratio (HR)	1.31			2-Sided	95	1.14	1.50				No	Superiority or Other

Secondary

Progression-Free Survival (PFS)

The period from randomization until disease progression or death.

Full Analysis Population

Posted

Median

95% Confidence Interval

Weeks

Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

Events

Participants

ID	Title	Description
OG000	Sunitinib	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
OG001	Sorafenib	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.

Units	Counts
Participants

Secondary

Time to Tumor Progression (TTP)

Full Analysis Population

Posted

Median

95% Confidence Interval

Weeks

Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150

Events

Participants

ID	Title	Description
OG000	Sunitinib	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
OG001	Sorafenib	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.

Secondary

European Quality of Life (EQ-5D)- Health State Profile Utility Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula assigns a utility value for each domain in the profile. Score is transformed and results in a score range -0.594 to 1.000; higher score indicates better health state.

Data were not collected per Amendment 2 to the protocol removing collection for this endpoint.

Posted

Day 1 of each cycle

ID	Title	Description
OG000	Sunitinib	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.
OG001	Sorafenib	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.

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	Sunitinib	Participants received sunitinib 37.5 milligram (mg) capsules by mouth once daily on a continuous daily dosing schedule. Dose reductions to either 25 mg or 12.5 mg were allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.			240	526	515	526
EG001	Sorafenib	Participants received sorafenib 400 mg tablets by mouth, twice daily (BID). Dose reduction to 400 mg once daily (QD) was allowed. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of participant consent, need for different cancer treatment, or another withdrawal criterion was met.			204	542	531	542

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected526 at risk EG0015 affected542 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0010 affected542 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected526 at risk EG0011 affected542 at risk
Angina pectoris	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Bradycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0012 affected542 at risk
Myocardial infarction	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Palpitations	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Cataract	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Diabetic retinopathy	Eye disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected526 at risk EG0015 affected542 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0015 affected542 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected526 at risk EG0016 affected542 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected526 at risk EG0019 affected542 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0012 affected542 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Enteritis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Gastric varices haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected526 at risk EG0014 affected542 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0010 affected542 at risk
Glossitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Ileus	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0012 affected542 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected526 at risk EG0012 affected542 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0012 affected542 at risk
Pancreatic enzyme abnormality	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00011 affected526 at risk EG0017 affected542 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0009 affected526 at risk EG0014 affected542 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected526 at risk EG0013 affected542 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Condition aggravated	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0009 affected526 at risk EG0016 affected542 at risk
Death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Device failure	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Disease progression	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00055 affected526 at risk EG00162 affected542 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected526 at risk EG0014 affected542 at risk
General physical health deterioration	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0016 affected542 at risk
Generalised oedema	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Hyperthermia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Malaise	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Multi-organ failure	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected526 at risk EG0019 affected542 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0015 affected542 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected526 at risk EG0014 affected542 at risk
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0012 affected542 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Jaundice	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Anaphylactic shock	Immune system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Abdominal infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Anal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Bacteraemia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Biliary sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Bronchitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Bronchopneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Campylobacter infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Escherichia sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Fungal oesophagitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Hepatitis B	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Herpes zoster	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Herpes zoster ophthalmic	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Infected skin ulcer	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Infectious peritonitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Liver abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0013 affected542 at risk
Lung infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Osteomyelitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Perineal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected526 at risk EG0015 affected542 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Rash pustular	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Scrotal abscess	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0006 affected526 at risk EG0017 affected542 at risk
Septic shock	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0010 affected542 at risk
Tuberculosis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Veillonella infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Alanine aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Blood bilirubin increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Hepatic enzyme increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Liver function test abnormal	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Neutrophil count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Platelet count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected526 at risk EG0011 affected542 at risk
White blood cell count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected526 at risk EG0014 affected542 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected526 at risk EG0013 affected542 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0014 affected542 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0010 affected542 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0013 affected542 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Liver carcinoma ruptured	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Nervous system neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Pharyngeal cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0004 affected526 at risk EG0011 affected542 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Tumour rupture	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0012 affected542 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Coma	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Convulsion	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Diabetic hyperglycaemic coma	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00015 affected526 at risk EG0014 affected542 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Lacunar infarction	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Loss of consciousness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Paralysis	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Alcoholism	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Confusional state	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Suicide attempt	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected526 at risk EG0011 affected542 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Renal impairment	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Urinary retention	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Scrotal erythema	Reproductive system and breast disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected526 at risk EG0014 affected542 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0010 affected542 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected526 at risk EG0011 affected542 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected526 at risk EG0011 affected542 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0012 affected542 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0011 affected542 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected526 at risk EG0013 affected542 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0012 affected542 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Haemorrhage	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0012 affected542 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Hypertensive crisis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Inferior vena caval occlusion	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Intra-abdominal haemorrhage	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected526 at risk EG0010 affected542 at risk
Phlebitis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected526 at risk EG0011 affected542 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00079 affected526 at risk EG00147 affected542 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00096 affected526 at risk EG00137 affected542 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG000119 affected526 at risk EG00119 affected542 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG000170 affected526 at risk EG00169 affected542 at risk
Hypothyroidism	Endocrine disorders	MedDRA 14.1	Non-systematic Assessment	EG00030 affected526 at risk EG0017 affected542 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00090 affected526 at risk EG00156 affected542 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000121 affected526 at risk EG001105 affected542 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00074 affected526 at risk EG00178 affected542 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00076 affected526 at risk EG00164 affected542 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00090 affected526 at risk EG00181 affected542 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000248 affected526 at risk EG001254 affected542 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00053 affected526 at risk EG00139 affected542 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00028 affected526 at risk EG00118 affected542 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000129 affected526 at risk EG00193 affected542 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00087 affected526 at risk EG00153 affected542 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG000103 affected526 at risk EG00161 affected542 at risk
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00078 affected526 at risk EG00160 affected542 at risk
Chest pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00021 affected526 at risk EG00130 affected542 at risk
Face oedema	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00035 affected526 at risk EG0015 affected542 at risk
Fatigue	General disorders	MedDRA 14.1	Non-systematic Assessment	EG000171 affected526 at risk EG001115 affected542 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00065 affected526 at risk EG00139 affected542 at risk
Oedema	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00046 affected526 at risk EG00123 affected542 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00071 affected526 at risk EG00146 affected542 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00025 affected526 at risk EG00129 affected542 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG000105 affected526 at risk EG001101 affected542 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG00059 affected526 at risk EG00143 affected542 at risk
Alanine aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00060 affected526 at risk EG00170 affected542 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00084 affected526 at risk EG00192 affected542 at risk
Blood bilirubin increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00030 affected526 at risk EG00130 affected542 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00017 affected526 at risk EG00128 affected542 at risk
Neutrophil count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00050 affected526 at risk EG0014 affected542 at risk
Platelet count	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00029 affected526 at risk EG0019 affected542 at risk
Platelet count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00065 affected526 at risk EG00116 affected542 at risk
Weight decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00044 affected526 at risk EG001115 affected542 at risk
White blood cell count decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG00045 affected526 at risk EG0015 affected542 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG000233 affected526 at risk EG001187 affected542 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG00047 affected526 at risk EG00142 affected542 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00046 affected526 at risk EG00140 affected542 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00014 affected526 at risk EG00127 affected542 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00048 affected526 at risk EG00117 affected542 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00069 affected526 at risk EG00115 affected542 at risk
Headache	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00043 affected526 at risk EG00140 affected542 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG00060 affected526 at risk EG00154 affected542 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG00044 affected526 at risk EG00138 affected542 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00077 affected526 at risk EG00162 affected542 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00010 affected526 at risk EG00149 affected542 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00053 affected526 at risk EG00132 affected542 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00063 affected526 at risk EG00125 affected542 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00030 affected526 at risk EG00119 affected542 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00019 affected526 at risk EG001154 affected542 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG000232 affected526 at risk EG001330 affected542 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00034 affected526 at risk EG00158 affected542 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG000108 affected526 at risk EG001147 affected542 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG00037 affected526 at risk EG0010 affected542 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG000109 affected526 at risk EG00195 affected542 at risk

Certain Agreements

Ancestor Terms

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

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009536	Niacinamide
D009539	Nicotinic Acids
D000147	Acids, Heterocyclic
D011725	Pyridines