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This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time between the treatment start date (date of the first infusion of bevacizumab) and date of all-cause death. | From the time of first dose of study treatment to the time of death from any cause (Up to 53 months) |
| Percentage of Participants With Bevacizumab Administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Elderly patients with metastatic colorectal cancer initiating first-line treatment with Avastin
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch D Abbeville; Medecine B1 | Abbeville | 80142 | France | |||
| Clinique Du Docteur Calabet; Cromg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32299778 | Derived | Francois E, Mineur L, Deplanque G, Laplaige P, Smith D, Gourgou S, Tanang A, Ionescu-Goga M, Veerabudun K, Lelarge Y, Kim S, Rollot F. Efficacy and Safety of Bevacizumab Combined With First-Line Chemotherapy in Elderly (>/=75 Years) Patients With Metastatic Colorectal Cancer: A Real-World Study. Clin Colorectal Cancer. 2020 Sep;19(3):e100-e109. doi: 10.1016/j.clcc.2020.02.009. Epub 2020 Apr 13. |
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The data in the study for participant flow, baseline characteristics, outcome measure and adverse events was collected for overall participants and not as per the dose administered to participants.
A total of 402 participants were enrolled from 100 French sites.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Up to 36 months |
| Percentage of Participants With Adverse Events (AEs) | 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 53 months |
| Percentage of Participants With Activities of Daily Living (ADL) | The Katz Activity of Daily Living (ADL) questionnaire scale contains 6 items evaluating in terms of autonomy or dependence the patient's ability to carry out basic activities of daily living (bathing, dressing, toileting, transfer, continence, feeding). Total score range 0 (low) to 6 (high). High score indicates participant is independent. | Baseline, Month 6, 12, 24 |
| Lawton Instrumental Activities of Daily Living Score (IADL) | The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a participant is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale (telephone use, shopping, cooking, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances). Participants are scored according to their level of functioning from 0 (low function, dependent) to 8 (high function, independent). Higher score for each domain represents better functional performance of the older people. | Baseline, Month 6, 12, 24 |
| Percentage of Participants With Balducci Score | Balducci score defines an algorithm for the individual participant according to age, ADL and modified IADL 4-items scores, estimated performance status and comorbidities, particularly cardiovascular, cancer, depression or anemia. Balducci score is categorized in the following- Type 1 (Harmonious), Type 2 (Intermediate) and Type 3 (Frail). Type 1 indicates better results and Type 3 indicates worse outcomes. | Baseline, Month 6, 12, 24 |
| Agen |
| 47000 |
| France |
| Ch D Agen; Medecine Interne II | Agen | 47923 | France |
| C.H. Du Pays D'aix En Provence Service du Dr Blanc | Aix-en-Provence | 13616 | France |
| Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire | Aix-en-Provence | 13617 | France |
| Chd Castelluccio; Oncologie | Ajaccio | 20176 | France |
| Clinique Claude Bernard; Onco Hematologie | Albi | 81030 | France |
| Chi D Alencon; Medecine Ambulatoire | Alençon | 61014 | France |
| Chi D Alencon; Medecine I | Alençon | 61014 | France |
| Hopital Nord; Medecine A | Amiens | 80054 | France |
| Clinique De L Europe; Pmsi | Amiens | 80090 | France |
| Clinique De L Europe; Radiotherapie Chimiotherapie | Amiens | 80090 | France |
| Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero | Amilly | 45200 | France |
| Cham; Medecine D | Amilly | 45200 | France |
| Ctre Radiotherapie Et Onco Medic | Amilly | 45200 | France |
| Hotel Dieu; Medecine A | Angers | 49093 | France |
| Cabinet Medical | Arras | 62000 | France |
| Centre Radiotherapie Marie Curie | Arras | 62000 | France |
| Ch D Ardeche Meridionale; Medecine A2 | Aubenas | 07205 | France |
| Ch D Auch; Med Interne Chimiotherapie | Auch | 32008 | France |
| Clinique Sainte Catherine; Hopital De Semaine | Avignon | 84918 | France |
| Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie | Bastia | 20200 | France |
| Hopital De Falconaja Furiani; Hopital De Jour | Bastia | 20604 | France |
| Centre Hospitalier de La Cote Basque; Oncologie | Bayonne | 64109 | France |
| Centre Hospitalier; Hematologie-Oncologie | Beauvais | 60021 | France |
| Hopital Jean Minjoz; Gastro Enterologie | Besançon | 25030 | France |
| Hopital Jean Minjoz; Hopital de Jour | Besançon | 25030 | France |
| HOPITAL JEAN MINJOZ; Oncologie | Besançon | 25030 | France |
| Clinique Anne D Artois; Gastro Enterologie | Béthune | 62404 | France |
| Clinique Champeau Mediterranee; Radiotherapie Oncologie | Béziers | 34535 | France |
| Hopital Avicenne; Cancerologie | Bobigny | 93009 | France |
| Clinique Tivoli; Sce Radiotherapie | Bordeaux | 33000 | France |
| Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie | Bordeaux | 33077 | France |
| Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie | Boulogne-sur-Mer | 62321 | France |
| Clinique Du Docteur Convert; Medecine | Bourg-en-Bresse | 01004 | France |
| Centre Hospitalier Fleyriat; Oncologie/Hematologie | Bourg-en-Bresse | 01012 | France |
| Ch De Fleyriat; Gastro Enterologie | Bourg-en-Bresse | 01012 | France |
| Hopital Augustin Morvan; Federation De Cancerologie | Brest | 29200 | France |
| Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie | Brest | 29220 | France |
| CMC de Bligny; Hopital de Jour | Briis-sous-Forges | 91640 | France |
| CMC de Bligny; Oncologie Court Sejour | Briis-sous-Forges | 91640 | France |
| CMC de Bligny; Oncologie SSR | Briis-sous-Forges | 91640 | France |
| Ch De Brive La Gaillarde; Radiotherapie Oncologie | Brive-la-Gaillarde | 19312 | France |
| Hopital Cote De Nacre; Gastro Enterologie | Caen | 14033 | France |
| Infirmerie Protestante; Endos Digestive Coelioscopie | Caluire-et-Cuire | 69300 | France |
| Hopital Pierre Nouveau; Medecine A | Cannes | 06400 | France |
| Ch Antoine Gayraud; Oncologie | Carcassonne | 11890 | France |
| Clinique Montreal; Chimiotherapie | Carcassonne | France |
| Clinique Du Parc; Hematologie | Castelnau Lez | 34170 | France |
| Cabinet Medical | Challes-les-Eaux | 73190 | France |
| Medipole De Savoie; Departement Oncologie | Challes-les-Eaux | 73190 | France |
| Oncologie 37; Bureau | Chambray-lès-Tours | 37170 | France |
| Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire | Champigny-sur-Marne | 94507 | France |
| Centre Hospitalier; Oncologie | Châteauroux | 36019 | France |
| Ch De Cholet; Gastro Enterologie | Cholet | 49325 | France |
| Pole Sante Republique;Oncologie Hematologie | Clermont-Ferrand | 63050 | France |
| Hopital Louis Pasteur; Medecine A | Colmar | 68024 | France |
| Polyclinique Saint Come; Hopital De Jour Oncologie | Compiègne | 60204 | France |
| CH Sud Francilien; Oncologie | Corbeil-Essonnes | 91100 | France |
| Ch Laennec; Medecine V | Creil | 60109 | France |
| CHU Henri Mondor; Service d'Oncologie Medicale | Créteil | 94010 | France |
| Ch De Dax; Radiotherapie Oncologie | Dax | 40107 | France |
| Centre Leonard De Vinci;Chimiotherapie | Dechy | 59187 | France |
| Centre Georges Francois Leclerc; Oncologie 3 | Dijon | 21079 | France |
| Hopital Victor Jousselin; Gastro Enterologie | Druex | 28102 | France |
| Centre D Oncologie Dunkerquois | Dunkirk | 59240 | France |
| Chi Eure Seine D Evreux; Oncologie Conventionnelle | Évreux | 27015 | France |
| Clinique Pasteur; Oncologie Medicale, Hematologie | Évreux | 27025 | France |
| Ch Jacques Monod;Medecine A4 B4 | Flers | 61104 | France |
| Hopital De Freyming; Secteur 1 | Freyming-Merlebach | 57804 | France |
| Chi De Frejus Saint Raphael; Hopital De Jour | Fréjus | 83608 | France |
| Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente | Gap | 05000 | France |
| Centre Gastro Loire | Gien | 45 500 | France |
| Hopital Nord Ouest;Gastro Enterologie | Gleizé | 69400 | France |
| CH Emmanuel Rain; Oncologie | Gonesse | 95503 | France |
| Hopital Prive De Chantilly; Medecine | Gouvieux Chantilly | 60500 | France |
| Hopital Alpha Sante De Hayange; Medecine B | Hayange | 57701 | France |
| Clinique Sainte Marguerite; Oncologie Medicale | Hyères | 83400 | France |
| Polyclinique de Blois; Chimiotherapie Ambulatoire | La Chaussée-Saint-Victor | 41260 | France |
| Centre Hospitalier Departemental Les Oudairies | La Roche-sur-Yon | 85925 | France |
| Centre Hospitalier Saint Louis; Oncologie Medicale | La Rochelle | 17019 | France |
| Hopital Albert Michallon; Oncologie | La Tronche | 38700 | France |
| Hopital Albert Michallon; Radiotherapie | La Tronche | 38700 | France |
| Ch De Lagny Sur Marne; Oncologie | Lagny-sur-Marne | 77405 | France |
| Hopital Robert Boulin; Oncologie | Libourne | 33505 | France |
| Polyclinique Du Bois; Oncologie | Lille | 59003 | France |
| Polyclinique De La Louviere; Chimiotherapie | Lille | 59042 | France |
| Ch De Longjumeau; Hopital De Jour Et Semaine | Longjumeau | 91161 | France |
| Clinique Des 4 Pavillons; Chimiotherapie | Lormont | 33310 | France |
| Hopital De La Croix Rousse;Hepato Gastro Entero | Lyon | 69317 | France |
| Ctre Consultations La Sauvegarde | Lyon | 69338 | France |
| Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie | Lyon | 69365 | France |
| Hopital Prive Jean Mermoz; Cancerologie | Lyon | 69373 | France |
| Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie | Lyon | 69373 | France |
| Clin Mut De Lyon Eugene Andre; Hopital De Jour 1er B | Lyon | 69424 | France |
| Hopital Edouard Herriot; Pavillon E Oncologie Medicale | Lyon | 69437 | France |
| Clinique Saint Francois; Oncologie Medicale | Mainvilliers | 28301 | France |
| Clinique Mutualiste Bonneveine; Oncologie Medicale | Marseille | 13008 | France |
| CH Prive Clairval; Chimiotherapie Ambulatoire | Marseille | 13274 | France |
| Hôpital Saint Joseph; Oncologie Medicale | Marseille | 13285 | France |
| Hopital Timone Adultes; Oncologie Digestive | Marseille | 13385 | France |
| Clinique Du Parc; Centre de Radiotherapie Gray | Maubeuge | 59600 | France |
| Hopital Clinique Claude Bernard; Oncologie Medicale | Metz | 57000 | France |
| Chra; Gastro Enterologie | Metz-Tessy | 74370 | France |
| Hopital Layne; Medecine A2 | Mont-de-Marsan | 40024 | France |
| Hopital Layne; Medecine Ambulatoire | Mont-de-Marsan | 40024 | France |
| Ch De Montauban; Medecine Interne | Montauban | 82013 | France |
| Site Le Mittan; Hopital De Jour | Montbéliard | 25209 | France |
| Ch De Montelimar; Gastro Enterologie Oncologie | Montélimar | 26216 | France |
| Ghi Le Raincy Montfermeil; Gastro Medecine Interne | Montfermeil | 93370 | France |
| Ghi Le Raincy Montfermeil; Radiotherapie Oncologie | Montfermeil | 93370 | France |
| Hopital Jacques Monod; Hopital De Semaine Unite 53 | Montivilliers | 76290 | France |
| Clinique Clementville; Hopital De Jour | Montpellier | 34070 | France |
| Hopital Saint Eloi; Hopital De Jour | Montpellier | 34295 | France |
| Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie | Montpellier | 34967 | France |
| Centre Azureen De Cancerologie; Cons externes | Mougins | 06250 | France |
| Clinique D Occitanie; Chimiotherapie Ambulatoire | Muret | 31605 | France |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE | Nancy | 54100 | France |
| Polyclinique Du Languedoc; Chimiotherapie | Narbonne | 11780 | France |
| Hopital Americain; Sce Oncologie | Neuilly-sur-Seine | 92200 | France |
| Ctre Radiotherapie Cyr Deguergue | Nevers | 58000 | France |
| Centre Antoine Lacassagne; Hopital De Jour A2 | Nice | 06189 | France |
| Hopital Caremeau; Gastro Enterologie | Nîmes | 30029 | France |
| Hopital Prive Armand Brillard; Groupe Sein Paris Est | Nogent-sur-Marne | 94130 | France |
| Polyclinique Des Murlins;Ambulatoire | Orléans | 45000 | France |
| Clinique sainte marie; chimiotherapie ambulatoire | Osny | 95520 | France |
| Hopital Des Diaconesses; Oncologie | Paris | 75571 | France |
| Hopital Saint Antoine; Oncologie Medicale | Paris | 75571 | France |
| CH Pitie Salpetriere; Hepathologie Gastro Enterologie | Paris | 75651 | France |
| GH Paris Saint Joseph; Hopital De Jour Oncologie | Paris | 75674 | France |
| Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie | Paris | 75877 | France |
| Hop Europeen Georges Pompidou; Gastro Enterologie | Paris | 75908 | France |
| HOPITAL TENON; Cancerologie Medicale | Paris | 75970 | France |
| Hopital Saint Jean; Hospitalisation Oncologie | Perpignan | 66046 | France |
| Hopital Du Haut-Leveque; Gastro-Enterologie | Pessac | 33604 | France |
| Clinique Francheville; Radiotherapie | Périgueux | 24000 | France |
| Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE | Périgueux | 24000 | France |
| Ch Lyon Sud; Chir Visc Sect Jules Courmont | Pierre-Bénite | 69495 | France |
| Ch Lyon Sud; Gastro Secteur Jules Courmont | Pierre-Bénite | 69495 | France |
| Ctre Hosp Des Vals D Ardeche; Medecine C | Privas | 07007 | France |
| Ch De Rambouillet; Medecine A2 | Rambouillet | 78514 | France |
| Ch Arrondissement De Montreuil; Medecine 1 | Rang-du-Fliers | 62180 | France |
| Centre Frederic Joliot Curie | Rouen | 76000 | France |
| Hopital Yves Le Foll; Hematologie Oncologie | Saint-Brieuc | 22027 | France |
| Ctre De Radiotherapie St Vincent | Saint-Grégoire | 35768 | France |
| Clinique de L'Union; Oncologie | Saint-Jean | 31240 | France |
| Memorial France Etats Unis; Hopital De Jour | Saint-Lô | 50009 | France |
| Centre Joliot Curie | Saint-Martin-Boulogne | 62280 | France |
| Ch De Saint Quentin; Gastro Enterologie Endoscopie | Saint-Quentin | 02321 | France |
| Ch De Selestat; Medecine A | Sélestat | 67604 | France |
| Centre Clinical; Oncologie Medicale | Soyaux | 16800 | France |
| Hopital Broussais; Medecine 2A | St-Malo | 35403 | France |
| Clinique Chir De L Orangerie; Chimiotherapie | Strasbourg | 67010 | France |
| Clinique Saint Anne; Hopital De Jour | Strasbourg | 67010 | France |
| Fondation Maison Sante Bagatelle; Gastro Enterologie | Talence | 33401 | France |
| Hopitaux Du Leman Site Thonon; Gastro Enterologie | Thonon-les-Bains | 74203 | France |
| Clinique Pasteur; Oncologie Medicale | Toulouse | 31076 | France |
| Hopital Joseph Ducuing; Medecine Interne | Toulouse | 31076 | France |
| Hopital Prive Du Vert Galant; Cons Specialisees | Tremblay-en-France | 93290 | France |
| Ch De Valence; Medecine 6 | Valence | 26953 | France |
| Clinique Oceane; Medecine B | Vannes | 56001 | France |
| Hopital Saint Nicolas; Medecine A | Verdun | 55107 | France |
| Clinique De La Porte Verte; EST 3 | Versailles | 78004 | France |
| Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie | Vénissieux | 69200 | France |
| Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie | Villeneuve-d'Ascq | 59657 | France |
| Safety Population |
|
| Efficacy Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The efficacy population included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival | Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The efficacy population (EFF) included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in study was collected for overall participants and not as per dose administered. | Posted | Median | 95% Confidence Interval | Months | From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time between the treatment start date (date of the first infusion of bevacizumab) and date of all-cause death. | The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants. | Posted | Median | 95% Confidence Interval | Months | From the time of first dose of study treatment to the time of death from any cause (Up to 53 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Bevacizumab Administration | The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. | Posted | Number | Percentage of participants | Up to 36 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | 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. | Safety population included all participants who had at least one infusion of bevacizumab. Data in the study was collected for overall participants and not as per dose administered to participants. | Posted | Number | Percentage of participants | Up to 53 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Activities of Daily Living (ADL) | The Katz Activity of Daily Living (ADL) questionnaire scale contains 6 items evaluating in terms of autonomy or dependence the patient's ability to carry out basic activities of daily living (bathing, dressing, toileting, transfer, continence, feeding). Total score range 0 (low) to 6 (high). High score indicates participant is independent. | The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants. | Posted | Number | Percentage of participants | Baseline, Month 6, 12, 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Lawton Instrumental Activities of Daily Living Score (IADL) | The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a participant is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale (telephone use, shopping, cooking, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances). Participants are scored according to their level of functioning from 0 (low function, dependent) to 8 (high function, independent). Higher score for each domain represents better functional performance of the older people. | The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 12, 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Balducci Score | Balducci score defines an algorithm for the individual participant according to age, ADL and modified IADL 4-items scores, estimated performance status and comorbidities, particularly cardiovascular, cancer, depression or anemia. Balducci score is categorized in the following- Type 1 (Harmonious), Type 2 (Intermediate) and Type 3 (Frail). Type 1 indicates better results and Type 3 indicates worse outcomes. | The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants. | Posted | Number | Percentage of participants | Baseline, Month 6, 12, 24 |
|
|
Up to 53 months
Safety population included all participants who had at least one infusion of bevacizumab. The data in the study was collected for overall participants and not as per dose administered to participants.
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 | Participants received initial dose of either 5 milligram per kilogram (mg/kg) every 2 weeks or 7.5 mg/kg every 3 weeks of bevacizumab irrespective of the age subgroup. | 98 | 383 | 169 | 383 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Jugular Vein Thrombosis | Vascular disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Subclavian Vein Thrombosis | Vascular disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Venous Thrombosis Limb | Vascular disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Ileal Fistula | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Haemorrhagic Stroke | Nervous system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Anastomotic Fistula | Injury, poisoning and procedural complications | MedDRA 15.1. | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Rectal Obstruction | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Gastrointestinal Toxicity | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Bronchial Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Ophthalmic Herpes Zoster | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Pseudomonal Sepsis | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 15.1. | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Face Oedema | General disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Vena Cava Thrombosis | Vascular disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 15.1. | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 15.1. | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 15.1. | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 15.1. | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Metabolic Alkalosis | Metabolism and nutrition disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Metabolic Disorder | Metabolism and nutrition disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Prothrombin Time Ratio Decreased | Investigations | MedDRA 15.1. | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 15.1. | Systematic Assessment |
| |
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1. | Systematic Assessment |
| |
| Tumour Perforation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1. | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Psychiatric Symptom | Psychiatric disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Dihydropyrimidine Dehydrogenase Deficiency | Congenital, familial and genetic disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Hepatectomy | Surgical and medical procedures | MedDRA 15.1. | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1. | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1. | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | 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
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