Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With At Least One Adverse Event (AE) | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | Up to 65 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST) | Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with metastatic colorectal cancer initiated on Avastin in combination with chemotherapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belgrade | 11000 | Serbia | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Colorectal Cancer (CRC) Cohort | Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Included all participants who were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CRC Cohort | Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants With At Least One Adverse Event (AE) | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | All participants who received at least 1 dose of study drug and underwent subsequent safety assessment were considered for the safety analysis. | Posted | Number | percentage of participants | Up to 65 months |
|
Up to 65 months
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 | CRC Cohort | Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 65 months |
| Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline | Up to 65 months |
| Percentage of Participants With Disease Progression or Death | Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions. | Up to 65 months |
| Progression Free Survival (PFS) | PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. | Up to 65 months |
| Belgrade |
| 11080 |
| Serbia |
| Kamenitz | 21204 | Serbia |
| Kragujevac | 34000 | Serbia |
| Niš | 18000 | Serbia |
| Withdrawal by Subject |
|
| Physician Decision |
|
| Death |
|
| Other |
|
| Missing |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST) | Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions. | All participants who received at least 1 dose of study drug were included in this analysis. | Posted | Number | percentage of participants | Up to 65 months |
|
|
|
| Secondary | Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline | Included participants whose CRC was identified as unresectable at baseline. | Posted | Number | percentage of participants | Up to 65 months |
|
|
|
| Secondary | Percentage of Participants With Disease Progression or Death | Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions. | Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment. | Posted | Number | percentage of participants | Up to 65 months |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. | Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment. | Posted | Median | 95% Confidence Interval | months | Up to 65 months |
|
|
|
| 23 |
| 191 |
| 9 |
| 191 |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Peripheral Artery Thrombosis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Gastrointestinal Necrosis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Impaired Healing | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Sudden Death | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Body Temperature Increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
|
| Post Procedural Complication | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (17.1) | 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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |