A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in... | NCT01077739

ID	Type	Description	Link
2009-012090-36

Label	Type	Description	Intervention Names
Avastin (bevacizumab) + standard of care	Experimental		Drug: fluorouracil (5FU) Drug: leucovorin Drug: bevacizumab [Avastin] Drug: capecitabine [Xeloda] Drug: oxaliplatin

Name	Type	Description	Arm Group Labels	Other Names
fluorouracil (5FU)	Drug	standard FOLFOX regimen	Avastin (bevacizumab) + standard of care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression	PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.	Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
PFS From the Start of First-Line Therapy	PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

ID	Title	Description
FG000	Bevacizumab + Oxaliplatin + Capecitabine	Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1; oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1; and capecitabine 1000 mg/m^2, orally (PO), twice daily (BID) on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.

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

Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression

PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.

ITT population

Posted

Median

95% Confidence Interval

months

Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months

ID	Title	Description
OG000	Bevacizumab + Oxaliplatin + Capecitabine	Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
OG001	Bevacizumab + FOLFOX	Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.

Units	Counts
Participants	OG00025 OG00150

Title

Denominators

Categories

Title	Measurements
	OG0006.3(4.1 to 7.6) OG0015.1(3.8 to 6.0)

Secondary

PFS From the Start of First-Line Therapy

PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.

ITT population.

Posted

Median

95% Confidence Interval

months

Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months

ID	Title	Description
OG000	Bevacizumab + Oxaliplatin + Capecitabine	Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
OG001	Bevacizumab + FOLFOX	Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.

Secondary

Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)

Percentage of participants with an overall response of CR or PR according to RECIST criteria.

CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

ITT population; only participants with RECIST evaluations were included in the analysis.

Posted

Number

percentage of participants

Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months

ID	Title	Description
OG000	Bevacizumab + Oxaliplatin + Capecitabine	Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
OG001	Bevacizumab + FOLFOX	Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.

Secondary

Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression

Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration.

ITT Population. Number (n) equals (=) number of participants assessed for the given parameter at the specified visit.

Posted

Geometric Mean

Standard Deviation

pg/mL

Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months

ID	Title	Description
OG000	Bevacizumab + Oxaliplatin + Capecitabine	Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
OG001	Bevacizumab + FOLFOX	Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected50 at risk
Enteritis	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Ileus	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Asthenia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Device dislocation	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Disease progression	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Drug intolerance	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
General physical health deterioration	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected50 at risk
Idiosyncratic drug reaction	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Obstruction	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Necrotising fasciitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Perirectal abscess	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Sepsis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Vaginal abscess	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected50 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0011 affected50 at risk
Epilepsy	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Confusional state	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Depression	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0018 affected50 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0014 affected50 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected25 at risk EG00110 affected50 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected25 at risk EG0017 affected50 at risk
Angina pectoris	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Arrhythmia	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Palpitation	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Pericardial effusion	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Tachycardia	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Lacrimation increased	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0009 affected25 at risk EG00113 affected50 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0013 affected50 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Ascites	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Colitis	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected50 at risk
Constipation	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected25 at risk EG0016 affected50 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG00014 affected25 at risk EG00121 affected50 at risk
Duodenitis	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0017 affected50 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG00010 affected25 at risk EG00116 affected50 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Oral disorder	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Steatorrhoea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0014 affected50 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0006 affected25 at risk EG0015 affected50 at risk
Asthenia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0005 affected25 at risk EG0017 affected50 at risk
Chest pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Chills	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Fatigue	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0009 affected25 at risk EG00122 affected50 at risk
Feeling cold	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
General physical health deterioration	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected25 at risk EG0010 affected50 at risk
Mucosal inflammation	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected50 at risk
Oedema	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Oedema peripheral	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0014 affected50 at risk
Pyrexia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected25 at risk EG0018 affected50 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0015 affected50 at risk
Hypersensitivity	Immune system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Anal abscess	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Bronchitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Escherichia infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Eye infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Febrile infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Gastroenteritis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Lung infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Nail infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Nasopharyngitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected50 at risk
Paronychia	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Pharyngitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Respiratory tract infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Rhinitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Sinusitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Tooth abscess	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Tooth infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Tracheitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Urinary tract infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Blood creatinine	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Blood creatinine increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Body temperature increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Gamma-glutamyltransferase abnormal	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected50 at risk
Weight decreased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected25 at risk EG0012 affected50 at risk
White blood cell count decreased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0009 affected25 at risk EG00112 affected50 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Gout	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected50 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0014 affected50 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected50 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0014 affected50 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected50 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected25 at risk EG0016 affected50 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected50 at risk
Sensation of heaviness	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Coordination abnormal	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Dysaesthesia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected25 at risk EG0011 affected50 at risk
Dysgeusia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0012 affected50 at risk
Memory impairment	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0007 affected25 at risk EG0019 affected50 at risk
Neurotoxicity	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected50 at risk
Paraesthesia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0006 affected25 at risk EG00110 affected50 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0005 affected25 at risk EG0010 affected50 at risk
Polyneuropathy	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected25 at risk EG0017 affected50 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Sensory disturbance	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Tremor	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Anxiety	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Apathy	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected50 at risk
Disorientation	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Insomnia	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0013 affected50 at risk
Haematuria	Renal and urinary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Proteinuria	Renal and urinary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected50 at risk
Renal pain	Renal and urinary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Breast cyst	Reproductive system and breast disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected25 at risk EG0012 affected50 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0013 affected50 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0014 affected50 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected25 at risk EG0011 affected50 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected50 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0008 affected25 at risk EG0012 affected50 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected50 at risk
Skin chapped	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected50 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk
Hypertension	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected25 at risk EG00113 affected50 at risk
Vascular insufficiency	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected50 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Aalst		9300	Belgium

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D005472	Fluorouracil
D002955	Leucovorin
D000068258	Bevacizumab
D000069287	Capecitabine
D000077150	Oxaliplatin

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes
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
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Title	Description
BG000	Bevacizumab + Oxaliplatin + Capecitabine	Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
BG001	Bevacizumab + FOLFOX	Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bevacizumab + Oxaliplatin + Capecitabine	Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.			12	25	24	25
EG001	Bevacizumab + FOLFOX	Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.			18	50	49	50