An Observational Study on Bevacizumab (Avastin) as First-... | NCT01343901

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bevacizumab		Participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases will be observed.	Drug: Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Participants with mCRC and having exclusively liver or liver and lung metastases who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion will be observed. All concomitant medications as used in routine clinical practice are allowed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery	Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place [missing metastases]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).	Baseline up to 36 months
Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery	The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.	Baseline up to 36 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With at Least One Disease and Comorbidity at Day 0	Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Esquirol Saint Hilaire		Agen		47002	France
C.H. Du Pays D'aix En Provence Service du Dr Blanc

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bevacizumab	All participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases for whom bevacizumab (Avastin) was administered as part of first line treatment for potentially resectable liver metastases as per treating physician discretion. All concomitant medications as used in daily routine clinical practice were allowed.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

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
	OG00084.6

Primary

Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery

The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.

Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.

Posted

Number

Percentage of participants

Baseline up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With at Least One Disease and Comorbidity at Day 0

Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.

Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given category.

Posted

Number

Percentage of participants

Day 0

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Different Previous Therapies at Day 0

Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX [folinic acid+5-fluorouracil+oxaliplatin], LV5FU2 [leucovorin+5-Fluorouracil], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported.

Efficacy population. Here number of participants analysed represents the number of participants evaluable for this outcome measure.

Posted

Number

Percentage of participants

Day 0

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period

Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

Cycles

Baseline up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period

Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.

Posted

Number

Percentage of participants

Baseline up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment

Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category.

Analysis population consisted of participants with disappeared metastasis left in place with or without surgery. Here number of participants analyzed represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given category.

Posted

Number

Percentage of participants

Baseline up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Disease Progression or Death

Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions.

Efficacy population

Posted

Number

Percentage of participants

Baseline until disease progression or death, whichever occurred first, assessed up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Progression-free Survival (PFS)

Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions.

Efficacy population.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or death, whichever occurred first, assessed up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Disease Relapse

Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion [participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.

Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.

Posted

Number

Percentage of participants

Baseline until disease progression or death, whichever occurred first, assessed up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants

Secondary

Relapse-free Survival (RFS)

RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion [participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.

Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.

Posted

Median

95% Confidence Interval

Months

Baseline until disease progression or death, whichever occurred first, assessed up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants

Secondary

Percentage of Participants Who Died

Efficacy population

Posted

Number

Percentage of participants

Baseline until death; assessed up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000205

Secondary

Overall Survival (OS)

OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.

Efficacy population

Posted

Median

95% Confidence Interval

months

Baseline until death, assessed up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery

For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%).

Efficacy population. Here number of participants analyzed represents the overall number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given category.

Posted

Number

Percentage of participants

Baseline up to 36 months

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Number of Cumulated Cycles of First Line Bevacizumab at Day 0

Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.

Posted

Mean

Standard Deviation

cycles

Day 0

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0

Efficacy population. Here, number of participants analyzed represents the number of participants evaluable for this outcome measure.

Posted

Number

Percentage of participants

Day 0

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Total Duration of First Line Bevacizumab Treatment at Day 0

Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.

Posted

Median

Full Range

months

Day 0

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Unresectability Criteria

Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.

Posted

Number

Percentage of participants

Day 0

ID	Title	Description
OG000	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.

Units	Counts
Participants	OG000

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	Bevacizumab	All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion were observed. All concomitant medications as used in routine clinical practice were allowed.			71	210	75	210

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0004 affected210 at risk
Subileus	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected210 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Jejunal perforation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Melaena	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Infectious peritonitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected210 at risk
Septic shock	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0004 affected210 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected210 at risk
Device related infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Erysipelas	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Sepsis syndrome	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
General physical health deterioration	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected210 at risk
Chills	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Hyperthermia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Pain	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0008 affected210 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Aortic thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Haematoma	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Hypertensive crisis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Phlebitis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Transient ischaemic attack	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Vascular injury	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Bladder dilatation	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Biloma	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Hepatic atrophy	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Aphasia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Nervous system disorder	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Cardiac failure	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected210 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Tumour perforation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Completed suicide	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk
Thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected210 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthenia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00044 affected210 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Non-systematic Assessment	EG00022 affected210 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00037 affected210 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00028 affected210 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected210 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected210 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00020 affected210 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG00016 affected210 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected210 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected210 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected210 at risk

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
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