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This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab 840/420 mg | Experimental | Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. |
|
| Pertuzumab 840/840 mg | Experimental | Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | 1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL) | Day 43 | |
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment. | From randomization of first participant to end of study (approximately 6 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium | |||
| UZ Leuven Gasthuisberg |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pertuzumab 840/420 mg | Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cisplatin | Drug | 80 mg/m2 on Day 1 of each cycle |
|
| Pertuzumab | Drug | loading dose of 840 mg, then 420 mg once every three weeks |
|
|
| Pertuzumab | Drug | 840 mg once every three weeks |
|
|
| Trastuzumab | Drug | loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles |
|
|
| Leuven |
| 3000 |
| Belgium |
| Masaryk Memorial Cancer Institute; Oncological Clinic | Brno | 656 53 | Czechia |
| Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| Fakultnà Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni | Prague | 150 06 | Czechia |
| University Hospital Na Bulovce; Institut of Radiation Oncology | Prague | 180 81 | Czechia |
| Hopital Morvan | Brest | 29200 | France |
| CRLCC Val dAurelle Paul Lam | Montpellier | 34298 | France |
| Hopital Robert Debre; DERMATOLOGIE | Reims | 51092 | France |
| Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo. | Berlin | 10117 | Germany |
| Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie | Braunschweig | 38114 | Germany |
| Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie | Frankfurt | 60488 | Germany |
| Klinikum Mannheim III. Medizinische Klinik | Mannheim | 68167 | Germany |
| Campus Universitario S.Venuta; Centro Oncologico T.Campanella | Catanzaro | Calabria | 88100 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 | Milan | Lombardy | 20133 | Italy |
| A.O. Universitaria Pisana; Oncologia | Pisa | Tuscany | 56100 | Italy |
| Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde | Maastricht | 6229 HX | Netherlands |
| Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology | Seoul | 03080 | South Korea |
| Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology | Seoul | 03722 | South Korea |
| Asan Medical Center; Medical Oncology | Seoul | 05505 | South Korea |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| FG001 | Pertuzumab 840/840 mg | Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pertuzumab 840/420 mg | Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. |
| BG001 | Pertuzumab 840/840 mg | Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles. |
| 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, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL) | The primary pharmacokinetic (PK) analysis population consisted of all participants with a measurable PK samples on Day 43. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 43 |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment. | Safety population included all participants who received at least one dose of study treatment. | Posted | Number | participants | From randomization of first participant to end of study (approximately 6 years) |
|
From randomization of first participant to end of study (approximately 6 years)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pertuzumab 840/420 mg | Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. | 10 | 15 | 11 | 15 | 15 | 15 |
| EG001 | Pertuzumab 840/840 mg | Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles. | 9 | 15 | 10 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | medDRA 20.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | medDRA 20.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Myoglobin blood increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Food intolerance | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | medDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Neutrophilia | Blood and lymphatic system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | medDRA 20.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | medDRA 20.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | medDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Stomatits | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Face oedema | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Xerosis | General disorders | medDRA 20.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Toxocariasis | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | medDRA 20.1 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | medDRA 20.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | medDRA 20.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | medDRA 20.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | medDRA 20.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase inreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood cholinesterase decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood iron increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Protein total decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Prothrombin time shortened | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Weight increased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyposideraemia | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypovitaminosis | Metabolism and nutrition disorders | medDRA 20.1 | Systematic Assessment |
| |
| Fracture pain | Musculoskeletal and connective tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Cholinergic syndrome | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | medDRA 20.1 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | medDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | medDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | medDRA 20.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | medDRA 20.1 | Systematic Assessment |
| |
| Somatic symptom disorder | Psychiatric disorders | medDRA 20.1 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | medDRA 20.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | medDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | medDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | medDRA 20.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | medDRA 20.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | medDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | medDRA 20.1 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | medDRA 20.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | medDRA 20.1 | Systematic Assessment |
| |
| Urine output decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | medDRA 20.1 | Systematic Assessment |
| |
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Greater than or equal to (>=) 65 years |
|
| Male |
|
|
|