A Study of Bevacizumab in Combination With Capecitabine a... | NCT00548548

ID	Type	Description	Link
BO20904	Other Identifier	Hoffmann-La Roche

Name	Class
Hoffmann-La Roche	INDUSTRY
Chugai Pharmaceutical	INDUSTRY

Label	Type	Description	Intervention Names
Bevacizumab	Experimental	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.	Drug: Bevacizumab Drug: Capecitabine Drug: Cisplatin Drug: 5-fluorouracil
Placebo	Placebo Comparator	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.	Drug: Capecitabine Drug: Cisplatin Drug: Placebo Drug: 5-fluorouracil

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Intravenous bevacizumab 7.5 mg/kg once every 3 weeks, given until disease progression or unmanageable toxicity.	Bevacizumab

Measure	Description	Time Frame
Overall Survival	The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method.	From randomization until death, up to 26 months

Measure	Description	Time Frame
Progression-free Survival	Progression-free survival (PFS) is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first. Patients who neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. Median PFS was estimated using the Kaplan-Meier method.

Name	Affiliation	Role
Eric Hedrick, MD	Genentech, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Tower Cancer Research Fnd		Beverly Hills	California	90211-1850	United States
Moores UCSD Cancer Center

PubMed Identifier	Type	Citation	Retractions
24942210	Derived	Han K, Jin J, Maia M, Lowe J, Sersch MA, Allison DE. Lower exposure and faster clearance of bevacizumab in gastric cancer and the impact of patient variables: analysis of individual data from AVAGAST phase III trial. AAPS J. 2014 Sep;16(5):1056-63. doi: 10.1208/s12248-014-9631-6. Epub 2014 Jun 19.
21844504	Derived

ID	Title	Description
FG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.

ID	Title	Description
BG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
BG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
BG002	Total	Total of all reporting groups

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

The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method.

The Intent-to-Treat population, including all randomized participants.

Posted

Median

95% Confidence Interval

months

From randomization until death, up to 26 months

ID	Title	Description
OG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
OG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.

Units	Counts
Participants	OG000387 OG001387

Title

Denominators

Categories

Title	Measurements
	OG00012.1(11.1 to 13.8) OG00110.1(9.0 to 11.3)

Secondary

Progression-free Survival

Progression-free survival (PFS) is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first. Patients who neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow up for progression of disease. Median PFS was estimated using the Kaplan-Meier method.

Intent to treat

Posted

Median

95% Confidence Interval

months

From randomization until disease progression or death, up to 26 months.

ID	Title	Description
OG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
OG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.

Secondary

Progression-free Survival During First-line Therapy

Progression-free survival (PFS) during first-line therapy is defined as the time between randomization and the date of first documented disease progression or death, whichever occurs first and only if it occurs no later than 28 days after last confirmed intake of any study medication and only if it occurs before the start of non-study antineoplastic treatment. Participants who did not progress or die in this interval or were lost to follow-up were censored at the date of the last tumor assessment within this time window. Median PFS was estimated using the Kaplan-Meier method.

Intent-to treat.

Posted

Median

95% Confidence Interval

months

From randomization until 28-days after the last study treatment was administered, up to 26 months.

ID	Title	Description
OG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
OG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.

Secondary

Time to Disease Progression

Time to progression is defined as the time from randomization to the first occurrence of progressive disease (PD). PD was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Patients with no PD at study completion (including those who died before PD) were censored at the date of the last tumor assessment. Median time to PD was estimated using the Kaplan-Meier method.

Intent-to-treat

Posted

Median

95% Confidence Interval

months

From randomization until disease progression; assessed every 6 weeks for the first year and every 12 weeks thereafter, up to 26 months.

ID	Title	Description
OG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
OG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.

Secondary

Participants With a Best Overall Response of Complete or Partial Response

Best overall response during first-line therapy is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response, as determined by the RECIST criteria. CR is defined as the disappearance of all target and non-target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions and no new or progression of non-target lesions, or the disappearance of all target lesions and persistence of one or more non-target lesion(s).

Measurable Disease Population, including all randomized participants with measurable disease (per RECIST) for gastric cancer at baseline. Patients were analyzed according to the treatment groups to which they were randomized.

Posted

Number

participants

From randomization until the end of study, up to 26 months.

ID	Title	Description
OG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
OG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.

Secondary

Duration of Response

Duration of response during first line therapy is defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. Median duration of response was estimated using the Kaplan-Meier method.

Participants with measurable disease at baseline who had a best overall response of complete response or partial response, and for whom duration of response data was available.

Posted

Median

95% Confidence Interval

months

From randomization to the end of study, up to 26 months

ID	Title	Description
OG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
OG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.

Secondary

Participants With Disease Control

Disease control for participants with measurable disease was defined as a complete response (CR), partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the RECIST criteria. For participants without measurable disease, disease control was defined as no disease progression for ≥ 6 weeks.

Intent-to-treat

Posted

Number

participants

From randomization until the end of study, up to 26 months.

ID	Title	Description
OG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
OG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.

Secondary

Participants With Adverse Events

The intensity of Adverse Events (AEs) was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0 on a five-point scale from Grade 1 (Mild) to Grade 5 (Death). A serious AE (SAE) was defined as any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Safety population, including all patients randomized and exposed to study medication (defined as any one component of the combination). Patients are assigned to treatment groups based on the treatment they actually received.

Posted

Number

participants

From randomization until 3 months after last dose (up to 26 months)

ID	Title	Description
OG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
OG001	Placebo

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
VOMITING	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00011 affected386 at risk EG00118 affected381 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00016 affected386 at risk EG0018 affected381 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0007 affected386 at risk EG00112 affected381 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0005 affected386 at risk EG0015 affected381 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0005 affected386 at risk EG0014 affected381 at risk
GASTRIC PERFORATION	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0007 affected386 at risk EG0010 affected381 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0012 affected381 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0013 affected381 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected386 at risk EG0011 affected381 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0012 affected381 at risk
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0012 affected381 at risk
GASTROINTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
GASTROINTESTINAL TOXICITY	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
ILEUS	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
OBSTRUCTION GASTRIC	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
PERITONITIS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
ACUTE ABDOMEN	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
COLITIS	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
DUODENAL PERFORATION	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ENTEROCUTANEOUS FISTULA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
FOOD POISONING	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
GASTRIC STENOSIS	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
GASTROINTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
ILEAL PERFORATION	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
LARGE INTESTINAL ULCER	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
OESOPHAGEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG00013 affected386 at risk EG00113 affected381 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0007 affected386 at risk EG00110 affected381 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0006 affected386 at risk EG0017 affected381 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0013 affected381 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
MICROANGIOPATHIC HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
SPLENIC INFARCTION	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0008 affected386 at risk EG00113 affected381 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0007 affected386 at risk EG0013 affected381 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0017 affected381 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
PNEUMONIA	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0008 affected386 at risk EG0017 affected381 at risk
SEPSIS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0004 affected386 at risk EG0011 affected381 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0003 affected386 at risk EG0011 affected381 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0012 affected381 at risk
INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
NEUTROPENIC INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0012 affected381 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
APPENDICITIS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
BACILLUS INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
BACTERAEMIA	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ERYSIPELAS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
LUNG ABSCESS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
NEUTROPENIC SEPSIS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
OSTEOMYELITIS CHRONIC	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PERITONITIS BACTERIAL	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
PNEUMONIA PRIMARY ATYPICAL	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
TOOTH INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
UROSEPSIS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
WOUND INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
ASTHENIA	General disorders	MedDRA (17.0)	Systematic Assessment	EG0004 affected386 at risk EG0016 affected381 at risk
FATIGUE	General disorders	MedDRA (17.0)	Systematic Assessment	EG0005 affected386 at risk EG0013 affected381 at risk
DEATH	General disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected386 at risk EG0014 affected381 at risk
PYREXIA	General disorders	MedDRA (17.0)	Systematic Assessment	EG0004 affected386 at risk EG0013 affected381 at risk
CHEST PAIN	General disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
ADVERSE DRUG REACTION	General disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
CATHETER THROMBOSIS	General disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
DISEASE PROGRESSION	General disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
HYPERPYREXIA	General disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0008 affected386 at risk EG00113 affected381 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0013 affected381 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0012 affected381 at risk
PULMONARY ARTERY THROMBOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0012 affected381 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PHARYNGEAL INFLAMMATION	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected386 at risk EG0014 affected381 at risk
HYPERTENSION	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
ARTERIAL THROMBOSIS LIMB	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
HAEMORRHAGE	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
HYPOTENSION	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
HYPOVOLAEMIC SHOCK	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
JUGULAR VEIN THROMBOSIS	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
THROMBOSIS	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
VASOSPASM	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0004 affected386 at risk EG0013 affected381 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0011 affected381 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
NEPHROPATHY TOXIC	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
RENAL SALT-WASTING SYNDROME	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0011 affected381 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0012 affected381 at risk
CONVULSION	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
NERVOUS SYSTEM DISORDER	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
AFFERENT LOOP SYNDROME	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
DEVICE MALFUNCTION	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
OESOPHAGEAL INJURY	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
PNEUMOTHORAX TRAUMATIC	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
STENT OCCLUSION	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0014 affected381 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
JAUNDICE	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
LIVER DISORDER	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
DEPRESSION	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
ANXIETY	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
RESTLESSNESS	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected386 at risk EG0010 affected381 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0011 affected381 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
TUMOUR HAEMORRHAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0012 affected381 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
TUMOUR NECROSIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
TUMOUR PERFORATION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
VERTIGO POSITIONAL	Ear and labyrinth disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
PEMPHIGOID	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
BLOOD POTASSIUM DECREASED	Investigations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
BLOOD SODIUM DECREASED	Investigations	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
RETINOPATHY	Eye disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ATYPICAL PNEUMONIA	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
DEVICE OCCLUSION	General disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
STENT MALFUNCTION	General disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
THROMBOSIS IN DEVICE	General disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
EMBOLISM	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
PERIPHERAL ARTERY THROMBOSIS	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
VIITH NERVE PARALYSIS	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
BILE DUCT STENOSIS	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected386 at risk EG0011 affected381 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk
STOMA SITE HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected386 at risk EG0010 affected381 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NAUSEA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG000264 affected386 at risk EG001248 affected381 at risk
VOMITING	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG000192 affected386 at risk EG001188 affected381 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG000180 affected386 at risk EG001142 affected381 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG000141 affected386 at risk EG001124 affected381 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG000111 affected386 at risk EG00188 affected381 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00082 affected386 at risk EG00155 affected381 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00039 affected386 at risk EG00132 affected381 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00023 affected386 at risk EG00116 affected381 at risk
GINGIVITIS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG00025 affected386 at risk EG0017 affected381 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG000250 affected386 at risk EG001221 affected381 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG00083 affected386 at risk EG001111 affected381 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG00070 affected386 at risk EG00167 affected381 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG00021 affected386 at risk EG00118 affected381 at risk
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG000183 affected386 at risk EG001124 affected381 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00094 affected386 at risk EG00187 affected381 at risk
SKIN HYPERPIGMENTATION	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00056 affected386 at risk EG00153 affected381 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00039 affected386 at risk EG00132 affected381 at risk
PIGMENTATION DISORDER	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00027 affected386 at risk EG00113 affected381 at risk
NAIL DISORDER	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00022 affected386 at risk EG00113 affected381 at risk
FATIGUE	General disorders	MedDRA (17.0)	Systematic Assessment	EG000157 affected386 at risk EG001145 affected381 at risk
ASTHENIA	General disorders	MedDRA (17.0)	Systematic Assessment	EG00077 affected386 at risk EG00164 affected381 at risk
PYREXIA	General disorders	MedDRA (17.0)	Systematic Assessment	EG00054 affected386 at risk EG00151 affected381 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA (17.0)	Systematic Assessment	EG00053 affected386 at risk EG00132 affected381 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (17.0)	Systematic Assessment	EG00030 affected386 at risk EG00137 affected381 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG00055 affected386 at risk EG00150 affected381 at risk
HEADACHE	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG00051 affected386 at risk EG00136 affected381 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG00042 affected386 at risk EG00141 affected381 at risk
DYSGEUSIA	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG00042 affected386 at risk EG00139 affected381 at risk
DIZZINESS	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG00038 affected386 at risk EG00141 affected381 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG000204 affected386 at risk EG001175 affected381 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG00052 affected386 at risk EG00156 affected381 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG00064 affected386 at risk EG00120 affected381 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG00018 affected386 at risk EG00125 affected381 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG00015 affected386 at risk EG00122 affected381 at risk
CREATININE RENAL CLEARANCE DECREASED	Investigations	MedDRA (17.0)	Systematic Assessment	EG00049 affected386 at risk EG00163 affected381 at risk
WEIGHT DECREASED	Investigations	MedDRA (17.0)	Systematic Assessment	EG00044 affected386 at risk EG00143 affected381 at risk
HYPERTENSION	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG00084 affected386 at risk EG00151 affected381 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00029 affected386 at risk EG00121 affected381 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00021 affected386 at risk EG0017 affected381 at risk
PROTEINURIA	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG00028 affected386 at risk EG00120 affected381 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG00024 affected386 at risk EG00121 affected381 at risk
INSOMNIA	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG00043 affected386 at risk EG00137 affected381 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG00026 affected386 at risk EG00115 affected381 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG00024 affected386 at risk EG00114 affected381 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG00017 affected386 at risk EG00118 affected381 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG00019 affected386 at risk EG00111 affected381 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00019 affected386 at risk EG00120 affected381 at risk

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bevacizumab	Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.			134	386	378	386
EG001	Placebo	Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.			137	381	373	381

ID	Term
D000068258	Bevacizumab
D000069287	Capecitabine
D002945	Cisplatin
D005472	Fluorouracil