A Study of Avastin (Bevacizumab) in Combination With XELO... | NCT00349336

NCT00349336

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: bevacizumab [Avastin] Drug: XELOX
2	Experimental		Drug: bevacizumab [Avastin] Drug: FOLFOX-4

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab [Avastin]	Drug	7.5mg/kg iv on day 1 of each 3 week cycle	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weekly Steady-state Exposure of Bevacizumab	Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.	Up to 48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time Zero to Last Measurable Plasma Concentration of Bevacizumab	Area under the serum concentration-time curve from time zero to the time of the last measurable plasma concentration (AUC 0-last). Estimation of the parameter was performed using non-compartmental methods.	Up to 48 weeks
Steady-state Exposure of Bevacizumab From Time Zero to Tau

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
BG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00032 BG00132 BG00264

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0002457.19± 359.5 OG0011709.8± 497.0

Primary

Weekly Steady-state Exposure of Bevacizumab

Area under the serum concentration-time curve per week, at steady state (AUCss per week). Estimation of the parameter was performed using non-compartmental methods.

Posted

Mean

Standard Deviation

day*ug/mL

Up to 48 weeks

ID	Title	Description
OG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
OG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Secondary

Steady-state Exposure of Bevacizumab From Time Zero to Tau

Area under the serum concentration-time curve from time zero to tau, at steady state (AUCss 0-tau), where tau was the length of the cycle, i.e., tau = 3 weeks for XELOX+BV and tau = 2 weeks for FOLFOX-4+BEV. Estimation of the parameter was performed using non-compartmental methods.

Posted

Mean

Standard Deviation

day*ug/mL

Up to 48 weeks

ID	Title	Description
OG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
OG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Secondary

Maximum Serum Concentration of Bevacizumab at Steady State

Maximum serum concentration at steady state (Css,max). Estimation of the parameter was performed using non-compartmental methods.

Posted

Mean

Standard Deviation

ug/mL

Up to 48 weeks

ID	Title	Description
OG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
OG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Units

Secondary

Minimum Serum Concentration of Bevacizumab at Steady State

Minimum serum concentration at steady state (Css, min). Estimation of the parameter was performed using non-compartmental methods.

Posted

Mean

Standard Deviation

ug/ml

Up to 48 weeks

ID	Title	Description
OG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
OG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Units

Secondary

Serum Clearance of Bevacizumab

Serum clearance (CL). Estimation of the parameter was performed using non-compartmental methods.

Posted

Mean

Standard Deviation

L/day

Up to 48 weeks

ID	Title	Description
OG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
OG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Units	Counts

Secondary

Time of Maximum Serum Concentration of Bevacizumab

Time of maximum serum concentration (tmax). Estimation of the parameter was performed using non-compartmental methods.

Posted

Mean

Standard Deviation

Up to 48 weeks

ID	Title	Description
OG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
OG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Units	Counts

Secondary

Volume of Distribution of Bevacizumab at Steady State

Volume of distribution at steady state (Vss). Estimation of the parameter was performed using non-compartmental methods.

Posted

Mean

Standard Deviation

Up to 48 weeks

ID	Title	Description
OG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
OG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Units	Counts

Secondary

Terminal Half-life of Bevacizumab

Terminal half-life (t1/2) (apparent elimination half-life). Estimation of the parameter was performed using non-compartmental methods.

Posted

Mean

Standard Deviation

Up to 48 weeks

ID	Title	Description
OG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
OG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	XELOX+Bevacizumab	XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).			9	32	32	32
EG001	FOLFOX-4+Bevacizumab	FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).			15	32	32	32

Serious Adverse Events

Term	Organ System	Statistical Information
Diarrhoea	Gastrointestinal disorders	EG0004 affected32 at risk EG0011 affected32 at risk
Abdominal Pain	Gastrointestinal disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Vomiting	Gastrointestinal disorders	EG0001 affected32 at risk EG0011 affected32 at risk
Gastrointestinal Obstruction	Gastrointestinal disorders	EG0000 affected32 at risk EG0011 affected32 at risk
Ileus	Gastrointestinal disorders	EG0001 affected32 at risk EG0010 affected32 at risk
Nausea	Gastrointestinal disorders	EG0000 affected32 at risk EG0011 affected32 at risk
Oesophagitis	Gastrointestinal disorders	EG0001 affected32 at risk EG0010 affected32 at risk
Rectal Haemorhage	Gastrointestinal disorders	EG0000 affected32 at risk EG0011 affected32 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	EG0000 affected32 at risk EG0011 affected32 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	EG0000 affected32 at risk EG0011 affected32 at risk
Fatigue	General disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Pyrexia	General disorders	EG0001 affected32 at risk EG0011 affected32 at risk
Catheter Thrombosis	General disorders	EG0000 affected32 at risk EG0011 affected32 at risk
Chest Pain	General disorders	EG0001 affected32 at risk EG0010 affected32 at risk
Anorectal Infection	Infections and infestations	EG0000 affected32 at risk EG0011 affected32 at risk
Infection	Infections and infestations	EG0000 affected32 at risk EG0011 affected32 at risk
Sepsis	Infections and infestations	EG0001 affected32 at risk EG0010 affected32 at risk
Dehydration	Metabolism and nutrition disorders	EG0002 affected32 at risk EG0010 affected32 at risk
Metabolic Acidosis	Metabolism and nutrition disorders	EG0001 affected32 at risk EG0010 affected32 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG0000 affected32 at risk EG0011 affected32 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	EG0000 affected32 at risk EG0011 affected32 at risk
Hypersensitivity	Immune system disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Bile Duct Obstruction	Hepatobiliary disorders	EG0001 affected32 at risk EG0010 affected32 at risk
Cholecystitis	Hepatobiliary disorders	EG0001 affected32 at risk EG0010 affected32 at risk
Gastrointestinal Anastomotic Leak	Injury, poisoning and procedural complications	EG0000 affected32 at risk EG0011 affected32 at risk
Haemorrhage	Vascular disorders	EG0000 affected32 at risk EG0011 affected32 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Diarrhoea	Gastrointestinal disorders	EG00020 affected32 at risk EG00123 affected32 at risk
Nausea	Gastrointestinal disorders	EG00026 affected32 at risk EG00116 affected32 at risk
Abdominal Pain	Gastrointestinal disorders	EG00011 affected32 at risk EG0018 affected32 at risk
Constipation	Gastrointestinal disorders	EG00010 affected32 at risk EG0019 affected32 at risk
Vomiting	Gastrointestinal disorders	EG0008 affected32 at risk EG0019 affected32 at risk
Stomatitis	Gastrointestinal disorders	EG0005 affected32 at risk EG0017 affected32 at risk
Flatulence	Gastrointestinal disorders	EG0009 affected32 at risk EG0011 affected32 at risk
Dyspepsia	Gastrointestinal disorders	EG0004 affected32 at risk EG0012 affected32 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	EG0001 affected32 at risk EG0015 affected32 at risk
Haemorrhoids	Gastrointestinal disorders	EG0003 affected32 at risk EG0013 affected32 at risk
Abdominal Distension	Gastrointestinal disorders	EG0003 affected32 at risk EG0012 affected32 at risk
Abdominal Pain Lower	Gastrointestinal disorders	EG0002 affected32 at risk EG0013 affected32 at risk
Abdominal Pain Upper	Gastrointestinal disorders	EG0004 affected32 at risk EG0011 affected32 at risk
Rectal Haemorrhage	Gastrointestinal disorders	EG0001 affected32 at risk EG0014 affected32 at risk
Abdominal Discomfort	Gastrointestinal disorders	EG0002 affected32 at risk EG0011 affected32 at risk
Dry Mouth	Gastrointestinal disorders	EG0001 affected32 at risk EG0012 affected32 at risk
Dysphagia	Gastrointestinal disorders	EG0001 affected32 at risk EG0012 affected32 at risk
Oral Pain	Gastrointestinal disorders	EG0001 affected32 at risk EG0012 affected32 at risk
Anal Fissure	Gastrointestinal disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Anorectal Discomfort	Gastrointestinal disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Gingival Bleeding	Gastrointestinal disorders	EG0002 affected32 at risk EG0010 affected32 at risk
Hypoaesthesia Oral	Gastrointestinal disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Mouth Haemorrhage	Gastrointestinal disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Mouth Ulceration	Gastrointestinal disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Fatigue	General disorders	EG00024 affected32 at risk EG00123 affected32 at risk
Temperature Intolerance	General disorders	EG00015 affected32 at risk EG00112 affected32 at risk
Mucosal Inflammation	General disorders	EG0006 affected32 at risk EG00111 affected32 at risk
Pyrexia	General disorders	EG0003 affected32 at risk EG0017 affected32 at risk
Oedema Peripheral	General disorders	EG0001 affected32 at risk EG0016 affected32 at risk
Influenza Like Illness	General disorders	EG0002 affected32 at risk EG0013 affected32 at risk
Injection Site Discolouration	General disorders	EG0003 affected32 at risk EG0012 affected32 at risk
Pain	General disorders	EG0003 affected32 at risk EG0012 affected32 at risk
Chest Pain	General disorders	EG0002 affected32 at risk EG0012 affected32 at risk
Chills	General disorders	EG0001 affected32 at risk EG0012 affected32 at risk
Mucosal Haemorrhage	General disorders	EG0002 affected32 at risk EG0011 affected32 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	EG00015 affected32 at risk EG00116 affected32 at risk
Neuropathy Peripheral	Nervous system disorders	EG00015 affected32 at risk EG00115 affected32 at risk
Headache	Nervous system disorders	EG00010 affected32 at risk EG00110 affected32 at risk
Dizziness	Nervous system disorders	EG0006 affected32 at risk EG0016 affected32 at risk
Paraesthesia	Nervous system disorders	EG0004 affected32 at risk EG0017 affected32 at risk
Dysgeusia	Nervous system disorders	EG0003 affected32 at risk EG0014 affected32 at risk
Dysaesthesia	Nervous system disorders	EG0001 affected32 at risk EG0012 affected32 at risk
Cranial Neuropathy	Nervous system disorders	EG0002 affected32 at risk EG0010 affected32 at risk
Disturbance in Attention	Nervous system disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Hypoaesthesia	Nervous system disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Syncope	Nervous system disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Palmar-Plantar Erythrodysaesthesia Syndrome	Skin and subcutaneous tissue disorders	EG00018 affected32 at risk EG0011 affected32 at risk
Alopecia	Skin and subcutaneous tissue disorders	EG0007 affected32 at risk EG0019 affected32 at risk
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	EG0007 affected32 at risk EG0017 affected32 at risk
Pruritis	Skin and subcutaneous tissue disorders	EG0003 affected32 at risk EG0013 affected32 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	EG0004 affected32 at risk EG0011 affected32 at risk
Nail Disorder	Skin and subcutaneous tissue disorders	EG0004 affected32 at risk EG0011 affected32 at risk
Rash	Skin and subcutaneous tissue disorders	EG0003 affected32 at risk EG0012 affected32 at risk
Skin Discolouration	Skin and subcutaneous tissue disorders	EG0003 affected32 at risk EG0012 affected32 at risk
Dry Skin	Skin and subcutaneous tissue disorders	EG0003 affected32 at risk EG0011 affected32 at risk
Skin Fissures	Skin and subcutaneous tissue disorders	EG0002 affected32 at risk EG0011 affected32 at risk
Erythema	Skin and subcutaneous tissue disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	EG0002 affected32 at risk EG0010 affected32 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG0007 affected32 at risk EG00113 affected32 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG0007 affected32 at risk EG0018 affected32 at risk
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	EG0003 affected32 at risk EG0017 affected32 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	EG0006 affected32 at risk EG0013 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0001 affected32 at risk EG0016 affected32 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	EG0006 affected32 at risk EG0011 affected32 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	EG0003 affected32 at risk EG0012 affected32 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	EG0001 affected32 at risk EG0012 affected32 at risk
Nasal Ulcer	Respiratory, thoracic and mediastinal disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	EG0002 affected32 at risk EG0010 affected32 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG0007 affected32 at risk EG0015 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0004 affected32 at risk EG0017 affected32 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG0003 affected32 at risk EG0016 affected32 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG0005 affected32 at risk EG0014 affected32 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	EG0001 affected32 at risk EG0014 affected32 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0002 affected32 at risk EG0012 affected32 at risk
Pain in Jaw	Musculoskeletal and connective tissue disorders	EG0001 affected32 at risk EG0013 affected32 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	EG0002 affected32 at risk EG0011 affected32 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	EG0002 affected32 at risk EG0011 affected32 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	EG0001 affected32 at risk EG0012 affected32 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	EG0002 affected32 at risk EG0010 affected32 at risk
Muscle Twitching	Musculoskeletal and connective tissue disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	EG0002 affected32 at risk EG0010 affected32 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	EG0002 affected32 at risk EG0010 affected32 at risk
Rhinitis	Infections and infestations	EG0005 affected32 at risk EG0016 affected32 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG0001 affected32 at risk EG0014 affected32 at risk
Nasopharyngitis	Infections and infestations	EG0002 affected32 at risk EG0012 affected32 at risk
Oral Herpes	Infections and infestations	EG0002 affected32 at risk EG0012 affected32 at risk
Urinary Tract Infection	Infections and infestations	EG0001 affected32 at risk EG0013 affected32 at risk
Central Line Infection	Infections and infestations	EG0000 affected32 at risk EG0012 affected32 at risk
Eye Infection	Infections and infestations	EG0002 affected32 at risk EG0010 affected32 at risk
Lower Respiratory Tract Infection	Infections and infestations	EG0000 affected32 at risk EG0012 affected32 at risk
Tooth Infection	Infections and infestations	EG0000 affected32 at risk EG0012 affected32 at risk
Anorexia	Metabolism and nutrition disorders	EG00016 affected32 at risk EG0018 affected32 at risk
Decrease Appetite	Metabolism and nutrition disorders	EG0002 affected32 at risk EG0014 affected32 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0002 affected32 at risk EG0011 affected32 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Hypertension	Vascular disorders	EG0007 affected32 at risk EG0017 affected32 at risk
Thrombosis	Vascular disorders	EG0001 affected32 at risk EG0014 affected32 at risk
Flushing	Vascular disorders	EG0000 affected32 at risk EG0013 affected32 at risk
Hot Flush	Vascular disorders	EG0000 affected32 at risk EG0013 affected32 at risk
Neutropenia	Blood and lymphatic system disorders	EG0004 affected32 at risk EG00114 affected32 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0001 affected32 at risk EG0012 affected32 at risk
Anaemia	Blood and lymphatic system disorders	EG0000 affected32 at risk EG0012 affected32 at risk
Insomnia	Psychiatric disorders	EG0009 affected32 at risk EG0019 affected32 at risk
Eye Pain	Eye disorders	EG0003 affected32 at risk EG0012 affected32 at risk
Lacrimation Increased	Eye disorders	EG0000 affected32 at risk EG0015 affected32 at risk
Weight Decreased	Investigations	EG0001 affected32 at risk EG0015 affected32 at risk
Gamma-Glutamyltransferase Increased	Investigations	EG0002 affected32 at risk EG0011 affected32 at risk
Hypersensitivity	Immune system disorders	EG0000 affected32 at risk EG0014 affected32 at risk
Proteinuria	Renal and urinary disorders	EG0001 affected32 at risk EG0013 affected32 at risk

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

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
D000068258	Bevacizumab
C519688	XELOX
C410216	Folfox protocol

Ancestor Terms

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

Units	Counts
Participants	OG00019 OG00118

Facility	Status	City	State	ZIP	Country	Contacts
		Box Hill		3128	Australia