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This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + gemcitabine | Placebo Comparator | Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). |
|
| Pertuzumab + gemcitabine | Active Comparator | Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo was provided as a single-use formulation for infusion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR. | Baseline to the end of the study (up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Objective Response | An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Patton, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Comprehensive Cancer Institute |
One subject in the placebo + gemcitabine arm did not receive any study treatment as the subject died of a cerebrovascular accident prior to the first scheduled dose. This subject was excluded from both the efficacy and safety analyses, per protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Gemcitabine | Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Placebo: Placebo was provided as a single-use formulation for infusion. Gemcitabine: Gemcitabine was provided as a solution for infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Gemcitabine |
| Drug |
Gemcitabine was provided as a solution for infusion. |
|
|
| Pertuzumab | Drug | Pertuzumab was provided as a single-use formulation for infusion. |
|
|
| Baseline to the end of the study (up to 1 year) |
| Duration of the Objective Response | Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause. | Baseline to the end of the study (up to 1 year) |
| Percentage of Participants Free From Disease Progression at 4 Months | 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 of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Baseline to Month 4 |
| Duration of Survival | Duration of survival was defined as the time from randomization until death from any cause. | Baseline to the end of the study (up to 1 year) |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| Northwest Alabama Cancer Center | Muscle Shoals | Alabama | 35661 | United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| Alta Bates Comp. Cancer Ctr | Berkeley | California | 94704 | United States |
| California Cancer Crae, Inc | Greenbrae | California | 94904 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| Southern California Permanente Medical Group (Kaiser) | San Diego | California | 92120 | United States |
| Sharp Healthcare | San Diego | California | 92123 | United States |
| Norwalk Medical Group | Norwalk | Connecticut | 06856 | United States |
| Hematology Oncology, P.C. | Stamford | Connecticut | 06902 | United States |
| Integrated Community Oncology Network | Jacksonville | Florida | 32256 | United States |
| Florida Hospital | Orlando | Florida | 32804 | United States |
| Memorial Health Univ. Med. Ctr. | Savannah | Georgia | 31404 | United States |
| St. Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| North Idaho Cancer Center | Coeur d'Alene | Idaho | 83814 | United States |
| University Of Chicago | Chicago | Illinois | 60637 | United States |
| Carle Clinic Association | Urbana | Illinois | 61801 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| St. Vincent Hospital | Indianapolis | Indiana | 46260 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Wayne State Univ. Barbara Ann Karmanos Cancer Inst. | Detroit | Michigan | 48201 | United States |
| Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey | 08003 | United States |
| Cooper Health System | Voorhees Township | New Jersey | 08043 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Ohio State University College of Medicaine | Columbus | Ohio | 43210 | United States |
| Pelvic Surgery Assoc. | Columbus | Ohio | 43222 | United States |
| Oklahoma Univ. Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Corvallis Clinic | Corvallis | Oregon | 97330 | United States |
| Kaiser Permanente Northwest Division | Portland | Oregon | 97227 | United States |
| Womens and Infants Hospital | Providence | Rhode Island | 02905 | United States |
| Northern Virginia Pelvic Surgery Assoc. | Annandale | Virginia | 22003 | United States |
| Carilion Gyn/Onc | Roanoke | Virginia | 24014 | United States |
| FG001 | Pertuzumab + Gemcitabine | Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles Gemcitabine: Gemcitabine was provided as a solution for infusion. Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population: All participants who received any amount of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Gemcitabine | Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Placebo: Placebo was provided as a single-use formulation for infusion. Gemcitabine: Gemcitabine was provided as a solution for infusion. |
| BG001 | Pertuzumab + Gemcitabine | Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles Gemcitabine: Gemcitabine was provided as a solution for infusion. Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion. |
| BG002 | Total | Total of all reporting groups |
| 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-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR. | Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | months | Baseline to the end of the study (up to 1 year) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Objective Response | An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions. | Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. | Posted | Number | percentage of participants | Baseline to the end of the study (up to 1 year) |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of the Objective Response | Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause. | Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. Only participants with an objective response were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Baseline to the end of the study (up to 1 year) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Free From Disease Progression at 4 Months | 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 of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. | Posted | Number | percentage of participants | Baseline to Month 4 |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Survival | Duration of survival was defined as the time from randomization until death from any cause. | Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | months | Baseline to the end of the study (up to 1 year) |
|
All adverse events were collected from the beginning of study treatment until 30 days after discontinuation of study treatment.
Safety population: All participants who received any amount of study treatment.
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 | Placebo + Gemcitabine | Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Placebo: Placebo was provided as a single-use formulation for infusion. Gemcitabine: Gemcitabine was provided as a solution for infusion. | 40 | 65 | 65 | 65 | ||
| EG001 | Pertuzumab + Gemcitabine | Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles Gemcitabine: Gemcitabine was provided as a solution for infusion. Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion. | 23 | 65 | 65 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| COLONIC STENOSIS | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| RESPIRATORY ARREST | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| CATHETER RELATED INFECTION | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CATHETER RELATED COMPLICATION | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| INFUSION RELATED REACTION | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HAEMOLYTIC URAEMIC SYNDROME | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| FEEDING TUBE COMPLICATION | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DERMATOMYOSITIS | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| INJECTION SITE IRRITATION | General disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| EJECTION FRACTION DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| BLOOD ALBUMIN DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| BLOOD URINE PRESENT | Investigations | MedDRA (10.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| NEUROPATHY | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA (10.1) | Systematic Assessment |
| |
| VULVOVAGINAL DRYNESS | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA (10.1) | 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 | Genentech, Inc. | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D005184 | Fallopian Tube Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|