Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008336-85 | EudraCT Number |
Not provided
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This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + paclitaxel + carboplatin | Experimental | Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab was supplied as a sterile solution for infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Objective Response | An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Amaral Carvalho | Jaú | São Paulo | 17210-080 | Brazil | ||
| Hospital das Clinicas - FMUSP, Oncologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24007819 | Derived | Gonzalez-Martin A, Gladieff L, Tholander B, Stroyakovsky D, Gore M, Scambia G, Kovalenko N, Oaknin A, Ronco JP, Freudensprung U, Pignata S; OCTAVIA Investigators. Efficacy and safety results from OCTAVIA, a single-arm phase II study evaluating front-line bevacizumab, carboplatin and weekly paclitaxel for ovarian cancer. Eur J Cancer. 2013 Dec;49(18):3831-8. doi: 10.1016/j.ejca.2013.08.002. Epub 2013 Sep 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Paclitaxel + Carboplatin | Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of each cycle, paclitaxel 80 milligrams per square meters of body surface (mg/m^2) IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an area under the curve (AUC) of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (milligrams [mg] equals [=] [glomerular filtration rate (GFR) + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paclitaxel | Drug | Paclitaxel was supplied locally in commercial batches. |
|
|
| Carboplatin | Drug | Carboplatin was supplied locally in commercial batches. |
|
|
| Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) |
| Duration of Response | Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression 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 treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level. | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) |
| Overall Survival at 1 Year and 2 Years | Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study. | Baseline to Year 2 |
| Biological Progression-free Interval | Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised). | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) |
| São Paulo |
| São Paulo |
| 05403-000 |
| Brazil |
| Centre Hospitalier Henri Duffaut; Hematologie | Avignon | 84902 | France |
| Clinique Tivoli; Sce Radiotherapie | Bordeaux | 33000 | France |
| Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | 33077 | France |
| Ch De Brive La Gaillarde; Radiotherapie Oncologie | Brive-la-Gaillarde | 19312 | France |
| Hopital Antoine Beclere; Service de Medecine Interne | Clamart | 92141 | France |
| Centre Georges Francois Leclerc; Oncologie 3 | Dijon | 21079 | France |
| Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente | Gap | 05000 | France |
| Institut Daniel Hollard | Grenoble | 38000 | France |
| Hôpital Saint Joseph; Oncologie Medicale | Marseille | 13285 | France |
| CHRA;Hematologie | Metz-Tessy | 74370 | France |
| Centre Antoine Lacassagne; Hopital De Jour A2 | Nice | 06189 | France |
| GH Paris Saint Joseph; Hopital De Jour Oncologie | Paris | 75674 | France |
| HOPITAL TENON; Cancerologie Medicale | Paris | 75970 | France |
| Hopital De La Miletrie; Hematologie Et Oncologie Medicale | Poitiers | 86021 | France |
| Institut de Cancerologie de La Loire; Radiotherapie | Saint-Priest-en-Jarez | 42271 | France |
| Centre Paul Strauss; Oncologie Medicale | Strasbourg | 67065 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Centre Alexis Vautrin; Oncologie Medicale | Vandœuvre-lès-Nancy | 54511 | France |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B | Naples | Campania | 80131 | Italy |
| A.O. Universitaria Policlinico Di Modena; Oncologia | Modena | Emilia-Romagna | 41100 | Italy |
| Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica | Rome | Lazio | 00168 | Italy |
| Universita' Cattolica Del Sacro Cuore; Reparto Ginecologia Oncologica | Campobasso | Molise | 86100 | Italy |
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands |
| Academisch Medisch Centrum; Inwendige Geneeskunde | Amsterdam | 1105 AZ | Netherlands |
| Medisch Spectrum Twente Enschede; Internal Medicine | Enschede | 7511 JX | Netherlands |
| Academ Ziekenhuis Groningen; Medical Oncology | Groningen | 9713 GZ | Netherlands |
| Mc Haaglanden, Locatie Antoniushove; Interne Geneeskunde | Leidschendam | 2262 BA | Netherlands |
| Sint Elizabeth Ziekenhuis; Inwendige Geneeskunde | Tilburg | 5022 GC | Netherlands |
| Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde | Zwolle | 8025 AB | Netherlands |
| The Norvegian Radium Hospital Montebello; Dept of Oncology | Oslo | 0379 | Norway |
| St. Olavs Hospital; Kvinneklinikken | Trondheim | 7006 | Norway |
| Regional Clinical Oncology Dispensary | Krasnodar | 350040 | Russia |
| Oncology Hospital; Chemotherapy Dept. | Moscow | 107005 | Russia |
| Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy | Moscow | 115478 | Russia |
| City Clinical Oncology Hospital | Moscow | 143423 | Russia |
| Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease | Obninsk, Kaluzhskaya Region | 249034 | Russia |
| St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary | Saint Petersburg | 197022 | Russia |
| SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary | Stavropol | 355045 | Russia |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | 08041 | Spain |
| Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | 28007 | Spain |
| Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Madrid | 28033 | Spain |
| Hospital Universitario ClÃnico San Carlos; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Málaga | 29010 | Spain |
| Instituto Valenciano Oncologia; Oncologia Medica | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| Sahlgrenska Universitetssjukhuset; Onkology | Gothenburg | SE-41 343 | Sweden |
| Uni Hospital Linkoeping; Dept. of Oncology | Linköping | 58185 | Sweden |
| Örebro University Hospital; Department of Gynecologic Oncology | Örebro | 70185 | Sweden |
| Norrlands Uni Hospital; Onkologi Avd. | Umeå | 90185 | Sweden |
| Akademiska sjukhuset, Onkologkliniken | Uppsala | 75185 | Sweden |
| Royal Marsden Hospital; Dept of Med-Onc | London | SW3 6JJ | United Kingdom |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Treatment |
|
|
Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin or paclitaxel).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Paclitaxel + Carboplatin | Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg IV on Day 1 of each cycle, paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle, and carboplatin IV to an AUC of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [GFR + 25] x 6). Following the initial treatment (bevacizumab + paclitaxel + carboplatin) period, participants received additional 3-week cycles of monotherapy bevacizumab 7.5 mg/kg IV during the maintenance treatment period. The total maximum bevacizumab treatment duration was 17 cycles, (12 months) which included both the initial treatment period and the bevacizumab monotherapy maintenance treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | 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-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first. | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Posted | Median | 90% Confidence Interval | Months | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response | An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level. | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) |
| |||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression 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 treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level. | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Posted | Median | 95% Confidence Interval | Months | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival at 1 Year and 2 Years | Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study. | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Year 2 |
|
| ||||||||||||||||||||||||||
| Secondary | Biological Progression-free Interval | Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised). | Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel). | Posted | Median | 95% Confidence Interval | Months | Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month) |
|
Baseline to the end of the study (up to 4 years, 1 month)
Safety population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).
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 + Paclitaxel + Carboplatin | Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. Bevacizumab: Bevacizumab was supplied as a sterile solution for infusion. Paclitaxel: Paclitaxel was supplied locally in commercial batches. Carboplatin: Carboplatin was supplied locally in commercial batches. | 43 | 189 | 186 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subileus | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Oesophagits | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Non-systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Postoperative adhesion | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Nail toxicity | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.0) | 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 | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided
|
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