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This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | 850 mg/m^2 po bid on Days 1-14 of each 3-week cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST). | Time to disease progression or death (through follow-up phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death, for any cause. | Time to death (through follow-up phase): Approximate Median of 718 days |
| Best Overall Clinical Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | XELOX Q3W + Bevacizumab | Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Oxaliplatin |
| Drug |
130 mg/m^2 IV on Day 1 of each 3-week cycle |
|
| bevacizumab | Drug | 7.5 mg/kg IV on Day 1 of each 3-week cycle |
|
| capecitabine | Drug | 1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle |
|
| Oxaliplatin | Drug | 85 mg/m^2 IV on Day 1 of each 2-week cycle |
|
| bevacizumab | Drug | 5 mg/kg IV on Day 1 of each 2-week cycle |
|
Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
| Through follow-up phase: Approximate Median of 318 days |
| Duration of Overall Clinical Response (CR or PR) | Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause. | Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days |
| XELOX Q2W + Bevacizumab |
Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks. |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | XELOX Q3W + Bevacizumab | Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks. |
| BG001 | XELOX Q2W + Bevacizumab | Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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) | Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST). | Intent-to-treat population | Posted | Median | 95% Confidence Interval | Days | Time to disease progression or death (through follow-up phase) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from the date of randomization to the date of death, for any cause. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | Days | Time to death (through follow-up phase): Approximate Median of 718 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Clinical Response | Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. | Intent-to-treat population | Posted | Number | Patients | Through follow-up phase: Approximate Median of 318 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Overall Clinical Response (CR or PR) | Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | Days to event | Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days |
|
Not provided
Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XELOX Q3W + Bevacizumab | Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks. | 84 | 208 | 202 | 208 | ||
| EG001 | XELOX Q2W + Bevacizumab | Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks. | 94 | 211 | 206 | 211 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Caecitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colonic Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Colonic Pseudo-Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrointestinal Perforation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ileitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ileus Paralytic | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Inflammatory Bowel Disease | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Mechanical Ileus | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pancreatitus | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pancreatitus Acute | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Small Intestinal Perforation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary Track Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Catheter Related Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Klebsiella Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Staphylococcal Sepsis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Viral Oesophagitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Catheter Thrombosis | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pulmonary Venous Thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Jugular Vein Thrombosis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vena Cava Thrombosis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bundle Branch Block Left | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Acute Prerenal Failure | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Calculus Ureteric | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ureteric Obstruction | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anastomotic Complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Incisional Hernia | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Wound Complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrointestinal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Metastatic Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Tumour Associated Fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Tumour Local Invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Conversion Disorder | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Violence-Related Symptom | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Temperature Intolerance | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Skin Reaction | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
Not provided
Not provided
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