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This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab [Avastin] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is >300 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | As prescribed by physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Bevacizumab Treatment | Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus [+] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and greater than or equal to [≥] 70 years) as well as for overall participants. | Baseline up to end of treatment (up to approximately 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and ≥70 years) as well as for overall participants. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Patients with 1st line treatment with bevacizumab in Belgium
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | 9300 | Belgium | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab: Overall | All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
| Baseline up to disease progression or death (up to approximately 3 years) |
| Percentage of Participants With Best Overall Response | Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (<70 years, 70-80 years, and >80 years) as well as for overall participants. | Baseline up to disease progression or death (up to approximately 3 years) |
| Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status measured on a 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported. | Baseline up to Cycle 51 (1 cycle = 21 days) |
| Antwerp |
| 2020 |
| Belgium |
| Assebroek | 8310 | Belgium |
| Aye | 6900 | Belgium |
| Bruges | 8000 | Belgium |
| Brussels | 1180 | Belgium |
| Charleroi | 6000 | Belgium |
| Haine-Saint-Paul | 7100 | Belgium |
| Hasselt | 3500 | Belgium |
| Ieper | 8900 | Belgium |
| Kortrijk | 8500 | Belgium |
| Liège | 4000 | Belgium |
| Mons | 7000 | Belgium |
| Namur | 5000 | Belgium |
| Roeselare | 8800 | Belgium |
| Sint-Niklaas | 9100 | Belgium |
| Tongeren | 3700 | Belgium |
| Tournai | 7500 | Belgium |
| Vilvoorde | 1800 | Belgium |
| Received Bevacizumab in First Line |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis population (FAS) included all participants who received bevacizumab in first line mCRC. Baseline characteristics were reported by age groups.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab: Age <70 Years | Participants aged less than (<) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
| BG001 | Bevacizumab: Age 70-80 Years | Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
| BG002 | Bevacizumab: Age >80 Years | Participants aged greater than (>) 80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
| BG003 | 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 | Reported age data represents age at screening; calculated as: (screening date minus [-] birth date) divided by (/) 365.25. | 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 | Duration of Bevacizumab Treatment | Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus [+] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and greater than or equal to [≥] 70 years) as well as for overall participants. | FAS. | Posted | Median | 95% Confidence Interval | months | Baseline up to end of treatment (up to approximately 3 years) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and ≥70 years) as well as for overall participants. | FAS. | Posted | Median | 95% Confidence Interval | months | Baseline up to disease progression or death (up to approximately 3 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Best Overall Response | Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (<70 years, 70-80 years, and >80 years) as well as for overall participants. | FAS. Here, number of participants analyzed = participants with available data for this outcome. | Posted | Number | percentage of participants | Baseline up to disease progression or death (up to approximately 3 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status measured on a 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported. | FAS. Here, number of participants analyzed = participants with available data for this outcome and n = participants with available data for specified category, for each arm, respectively. No participants were evaluable for Cycles 48-50; hence, no data reported for these cycles. | Posted | Number | percentage of participants | Baseline up to Cycle 51 (1 cycle = 21 days) |
|
Up to approximately 3 years
Not provided
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 | Bevacizumab: Overall | All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. | 94 | 201 | 34 | 201 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyschezia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Faecalith | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ulcer | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bacterial prostatitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peripheral paralysis | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cancer surgery | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hepatectomy | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | 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 | Hoffman-La Roche | 800-821-8590 | genentech@druginfo.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 |
|---|---|
| D000068258 | Bevacizumab |
| 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
| Male |
|
Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups "70-80 Years" and ">80 Years" have been pooled in this group. |
| OG002 | Bevacizumab: Overall | All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
|
|
|
| OG001 | Bevacizumab: Age 70-80 Years | Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
| OG002 | Bevacizumab: Age >80 Years | Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
| OG003 | Bevacizumab: Overall | All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
|
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| Bevacizumab: Age 70-80 Years |
Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
| OG002 | Bevacizumab: Age >80 Years | Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
| OG003 | Bevacizumab: Overall | All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. |
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