Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ROC-BEV-2015-01 | Other Identifier | Hoffmann-La Roche |
Not provided
Not provided
Not provided
Not provided
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This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.
Not provided
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Metastatic Breast Cancer | Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab will be administered as per local clinical practice and local labeling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Benefit | Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. Results for clinical benefit were reported for 2 groups based on Circulating Tumor Cells (CTC) Levels. The Sensitive group had CTC levels <5 (<5 CTCs in one of the two determinations) and Resistant group had CTC ≥5 (≥ 5 CTCs in the two determinations). | During follow-up (up to 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response as Assessed Using RECIST v1.1 | Overall response = Complete Response (CR) + Partial Response (PR). Overall response was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5). | From Baseline up to end of study (up to 18 months) |
| Progression Free Survival (PFS) as Assessed Using RECIST v1.1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants with human epidermal growth factor receptor 2 (HER2)-negative aggressive metastatic breast cancer treated with standard first line chemotherapy with paclitaxel-bevacizumab.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Son Espases; Servicio de Oncologia | Palma de Mallorca | Balearic Islands | 07014 | Spain | ||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Metastatic Breast Cancer | Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 1, 2017 | Nov 25, 2019 |
Not provided
Not provided
Not provided
Not provided
| Paclitaxel | Drug | Paclitaxel will be administered as per local clinical practice and local labeling. |
|
PFS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5). |
| From Baseline up to end of study (up to 18 months) |
| Overall Survival | OS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5). | From Baseline up to end of study (up to 18 months) |
| Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4 | Adverse events (AEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0). Any AEs that are not specifically listed in the NCI CTCAE follow the logic - Grade 3) Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4: Life-threatening consequences or urgent intervention indicated. | From Baseline up to end of study (up to 18 months) |
| Optimal Cut-off for Clinical Benefit | Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. The optimal cut-off for clinical benefit was calculated from a Receiver Operating Curve (ROC) based on CTC level and used to define the prognostic factors that could better predict clinical outcomes. | Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days) |
| Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups | Overall response = CR + PR. An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups. | Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days) |
| PFS as Assessed Using RECIST v1. in Prognostic Groups | An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups. | From Baseline up to end of study (up to 18 months) |
| Mean CTC Count Levels | CTC and CEA levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered. | Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]) |
| Mean Carcinoembryonic Antigen (CEA) Levels | Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]) |
| Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level | CTC and CA 15.3 levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered. | Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]) |
| Hospital Provincial de Castellon; Servicio de Oncologia |
| Castellon |
| Castellon |
| 12002 |
| Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Hospital de Donostia.; Servicio de Oncología Radioterápica | San Sebastián | Guipuzcoa | 20014 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia | Las Palmas de Gran Canaria | LAS Palmas | 35016 | Spain |
| Hospital de Navarra; Servicio de Oncologia | Navarra | Navarre | 31008 | Spain |
| Hospital Quiron Barcelona; Servicio de Oncologia | Barcelona | 08024 | Spain |
| Hospital Universitario Virgen de las Nieves; Servicio de Oncologia | Granada | 18014 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaén | 23007 | Spain |
| Complejo Asistencial Universitario de Leon; Servicio de Oncologia | León | 24071 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia | Lleida | 25198 | Spain |
| Hospital Lucus Augusti; Servicio de Oncologia | Lugo | 27003 | Spain |
| Hospital Universitario de la Princesa; Servicio de Oncologia | Madrid | 28006 | Spain |
| Centro Oncologico MD Anderson Internacional; Servicio de Oncologia | Madrid | 28033 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia | Murcia | 30008 | Spain |
| Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia | Murcia | 30120 | Spain |
| Hospital Clinico Universitario de Salamanca; Servicio de Oncologia | Salamanca | 37007 | Spain |
| Hospital General de Segovia; Servicio de Oncologia | Segovia | 40002 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Oncologia | Seville | 41009 | Spain |
| Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia | Valencia | 46015 | Spain |
| Hospital Universitario Dr. Peset; Servicio de Oncologia | Valencia | 46017 | Spain |
| Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio Oncologia | Zamora | 49021 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Metastatic Breast Cancer | Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment. |
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Percentage of Participants With Clinical Benefit | Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. Results for clinical benefit were reported for 2 groups based on Circulating Tumor Cells (CTC) Levels. The Sensitive group had CTC levels <5 (<5 CTCs in one of the two determinations) and Resistant group had CTC ≥5 (≥ 5 CTCs in the two determinations). | Included participants that were evaluable for CTC level after cycle 2. | Posted | Count of Participants | Participants | During follow-up (up to 18 months) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Response as Assessed Using RECIST v1.1 | Overall response = Complete Response (CR) + Partial Response (PR). Overall response was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5). | Included participants that were evaluable for CTC level after cycle 2. | Posted | Count of Participants | Participants | From Baseline up to end of study (up to 18 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) as Assessed Using RECIST v1.1 | PFS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5). | Included participants that were evaluable for CTC level after cycle 2. | Posted | Median | 95% Confidence Interval | months | From Baseline up to end of study (up to 18 months) |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | OS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5). | Included only participants that were evaluable for CTC level after cycle 2. | Posted | Median | 95% Confidence Interval | months | From Baseline up to end of study (up to 18 months) |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4 | Adverse events (AEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0). Any AEs that are not specifically listed in the NCI CTCAE follow the logic - Grade 3) Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4: Life-threatening consequences or urgent intervention indicated. | Included only participants that were evaluable for CTC level after cycle 2. | Posted | Count of Participants | Participants | From Baseline up to end of study (up to 18 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Optimal Cut-off for Clinical Benefit | Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. The optimal cut-off for clinical benefit was calculated from a Receiver Operating Curve (ROC) based on CTC level and used to define the prognostic factors that could better predict clinical outcomes. | Included only participants that were evaluable for CTC level after cycle 2. | Posted | Number | cells/7.5 ml | Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups | Overall response = CR + PR. An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups. | Included only participants that were evaluable for CTC level after cycle 2. | Posted | Count of Participants | Participants | Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | PFS as Assessed Using RECIST v1. in Prognostic Groups | An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups. | Included only participants that were evaluable for CTC level after cycle 2. | Posted | Median | 95% Confidence Interval | months | From Baseline up to end of study (up to 18 months) |
|
| ||||||||||||||||||||||||||||
| Secondary | Mean CTC Count Levels | CTC and CEA levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered. | Only included participants that had available data of CTC levels at baseline | Posted | Mean | Standard Deviation | count/7.5 ml (CTC) | Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]) |
|
| ||||||||||||||||||||||||||||
| Secondary | Mean Carcinoembryonic Antigen (CEA) Levels | Only included participants that had available data of CEA levels at baseline | Posted | Mean | Standard Deviation | U/ml | Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]) |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level | CTC and CA 15.3 levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered. | Only included participants that had available data of CA 15.3 levels at baseline | Posted | Mean | Standard Deviation | U/ml | Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days]) |
|
|
From Baseline up to end of study (up to 18 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Metastatic Breast Cancer | Participants with metastatic breast cancer receiving bevacizumab in combination with paclitaxel, will be observed for treatment responses for up to 18 months from the start of treatment. | 37 | 111 | 37 | 111 | 107 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PERITONEAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| VASCULAR DEVICE INFECTION | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ABDOMINAL SEPSIS | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| CONFUSIONAL STATE | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| EXTRAOCULAR MUSCLE PARESIS | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DYSGEUSIA | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| GINGIVAL BLEEDING | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NEUROTOXICITY | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| POLYNEUROPATHY | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| NAIL TOXICITY | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| ONYCHOLYSIS | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| EPISTAXIS | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2018 | Nov 25, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| 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 |
Not provided
Not provided
| Race : Black |
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| Race : Arab |
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| Resistant |
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