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| Name | Class |
|---|---|
| Merck Pte. Ltd., Singapore | INDUSTRY |
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This is an open-label, non-randomized, multicenter Phase II study evaluating folinic acid + fluorouracil + irinotecan (FOLFIRI) plus cetuximab (Erbitux) or folinic acid + fluorouracil + oxaliplatin (FOLFOX) plus cetuximab as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Only subjects with k-ras oncogene (KRAS) wild-type tumors are eligible. Efficacy will be assessed every 8 weeks. Treatment will be continued until progressive disease or unacceptable adverse events occur. After the end of study treatment, information on further anticancer treatment and survival will be collected every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab plus FOLFIRI | Experimental |
| |
| Cetuximab plus FOLFOX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | Cetuximab will be administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Best Overall Confirmed Response Rate (BORR) | Response rate was defined as the percentage of subjects with BORR (confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks. | From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Time | PFS time was defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 90 days of the last tumor assessment or first study drug dose whichever occurred. | From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014) |
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Inclusion Criteria:
Signed written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Pte. Ltd., Singapore | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Singapore | Singapore |
Enrolled: 661 screened for eligibility; 372 were excluded (mainly non-fulfillment of inclusion or exclusion criteria). 289 subjects were assigned to the treatment groups.
First/Last subject (informed consent): February 2009/June 2012. Study completion date: April 2014. Clinical data cut-off: 31 March 2014. Subjects were recruited in 12 countries (Australia, China, Hong Kong, India, Indonesia, Korea, Malaysia, Singapore, Pakistan, Philippines, Taiwan and Thailand) across the globe in 43 centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab Plus FOLFIRI | Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| FOLFIRI | Drug | Irinotecan will be administered intravenously at a dose of 180 mg/m^2 along with folinic acid administration intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil will be administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal. |
|
| FOLFOX | Drug | Oxaliplatin will be administered intravenously at a dose of 100 mg/m^2 along with folinic acid administration intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil administration intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal. |
|
| Overall Survival (OS) Time | OS time was defined as the time from first administration of study drug until date of death, assessed up to 5 years. OS time was censored if the subject was found to be alive on the last date of the assessment. | From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014) |
| Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death | An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014) |
| FG001 | Cetuximab Plus FOLFOX | Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent. |
| COMPLETED |
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| NOT COMPLETED |
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Intention-to-treat (ITT) population consisted of all the enrolled subjects who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetuximab Plus FOLFIRI | Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfiri (Irinotecan administered intravenously at a dose of 180 mg/m^2 ,folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent. |
| BG001 | Cetuximab Plus FOLFOX | Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Percentage of Subjects With Best Overall Confirmed Response Rate (BORR) | Response rate was defined as the percentage of subjects with BORR (confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks. | Intention-to-treat (ITT) population consisted of all the enrolled subjects who received at least one dose of study treatment. | Posted | Number | Percentage of subjects | From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Time | PFS time was defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 90 days of the last tumor assessment or first study drug dose whichever occurred. | The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | months | From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Time | OS time was defined as the time from first administration of study drug until date of death, assessed up to 5 years. OS time was censored if the subject was found to be alive on the last date of the assessment. | The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment. | Posted | Median | 95% Confidence Interval | months | From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death | An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety population consisted of all the enrolled subjects who received at least one dose of study treatment. | Posted | Number | Subjects | From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014) |
|
From the start of the trial treatment up to the data cut-off date (31 March 2014)
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetuximab Plus FOLFIRI | Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Irinotecan was administered intravenously at a dose of 180 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal. | 37 | 101 | 93 | 101 | ||
| EG001 | Cetuximab Plus FOLFOX | Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly until disease progression, death, or consent withdrawal. Oxaliplatin was administered intravenously at a dose of 100 mg/m^2 along with folinic acid intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form) and 5-fluorouracil at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion of 2,400 mg/m^2 given biweekly until disease progression, death, or consent withdrawal. | 64 | 188 | 177 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Rectal obstruction | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Mycobacterium abscessus infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Tumor perforation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dysaesthesia pharynx | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Eye disorders | Eye disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| peripheral sensory neuropathy | Nervous system disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA Version(17.0) | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA Version(17.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono, a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
| 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 |
|---|---|
| D000068818 | Cetuximab |
| C480833 | IFL protocol |
| C410216 | Folfox protocol |
| 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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|
|
| OG001 | Cetuximab Plus FOLFOX | Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) biweekly followed by Folfox (Oxaliplatin administered intravenously at a dose of 180 mg/m^2, folinic acid administered intravenously at a dose of 400 mg/m^2 (racemic) or 200 mg/m^2 (L-form), 5-fluorouracil administered intravenously at a dose of 400 mg/m^2 bolus followed by a 46-hour continuous infusion at a dose of 2,400 mg/m^2) on Day 1 of 14 days treatment cycle until disease progression, occurrence of unacceptable toxicity, or withdrawal of consent. |
|
|