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This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + Chemotherapy | Experimental | Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. | Baseline up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died | Baseline up to approximately 3 years | |
| Duration of Survival | Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chai Yi | 613 | Taiwan | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Chemotherapy | Participants received bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks (q2w) in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bevacizumab | Drug | Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study. |
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| Irinotecan | Drug | Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study. |
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| Oxaliplatin | Drug | Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study. |
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| Baseline up to approximately 3 years |
| Percentage of Participants With Disease Progression or Death | Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL). | Baseline up to approximately 3 years |
| Progression-Free Survival Time | Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis. | Baseline up to approximately 3 years |
| Number of Participants With Best Overall Response | The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD. | Baseline up to approximately 3 years |
| Mean Direct Medical Cost for Cancer Related Medical Care Utilization | Direct medical cost included cost of out-patient consultation and cost of hospitalization. | Baseline up to approximately 3 years |
| Kaohsiung City |
| 00833 |
| Taiwan |
| Kaohsiung City | 807 | Taiwan |
| Taichung | 404 | Taiwan |
| Taichung | 407 | Taiwan |
| Tainan | 704 | Taiwan |
| Tainan | 710 | Taiwan |
| Taipei | 104 | Taiwan |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all participants receiving at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Chemotherapy | Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 Adverse Events | An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. | ITT population. | Posted | Number | percentage of participants | Baseline up to approximately 3 years |
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| Secondary | Percentage of Participants Who Died | ITT population. | Posted | Number | percentage of participants | Baseline up to approximately 3 years |
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| Secondary | Duration of Survival | Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis. | ITT population. | Posted | Median | 95% Confidence Interval | months | Baseline up to approximately 3 years |
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| Secondary | Percentage of Participants With Disease Progression or Death | Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL). | ITT population. | Posted | Number | percentage of participants | Baseline up to approximately 3 years |
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| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival Time | Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis. | ITT population. | Posted | Median | 95% Confidence Interval | months | Baseline up to approximately 3 years |
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| Secondary | Number of Participants With Best Overall Response | The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD. | ITT population. | Posted | Number | participants | Baseline up to approximately 3 years |
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| Secondary | Mean Direct Medical Cost for Cancer Related Medical Care Utilization | Direct medical cost included cost of out-patient consultation and cost of hospitalization. | ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Number Analyzed = participants who were evaluable for specified categories of this outcome measure. | Posted | Mean | Standard Deviation | Thousands in New Taiwan Dollar | Baseline up to approximately 3 years |
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Baseline up to approximately 3 years
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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 | Bevacizumab + Chemotherapy | Participants received IV bevacizumab at a dose of 5 mg/kg q2w in combination with standard of care chemotherapy regimen until disease progression or until termination of the study. | 14 | 40 | 40 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Disease progression | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Abscess | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Epididymitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Periodontal disease | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Impaired healing | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
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| Sensory level abnormal | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA (18.1) | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
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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 | 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 |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| D000077146 | Irinotecan |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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