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This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab | Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Hormone Receptor Status of Participants Without Progression | The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival. | Up to 3 years |
| Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment | Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HER2-positive metastatic breast cancer or locally advanced breast cancer whose systemic treatment included Herceptin as 1st line therapy, and who were without progression for at least 3 years after beginning Herceptin
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Du Docteur Calabet; Cromg | Agen | 47000 | France | |||
| C.H. Du Pays D'aix En Provence Service du Dr Blanc |
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A total of 160 participants were recruited from 28 March 2011 to 16 November 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab | Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab (Herceptin) as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Up to 12 years |
| Time to Progression | The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease. | Up to 12 years |
| Overall Survival | The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause. | Up to 12 years |
| Dosage Schedule of Herceptin Treatment | Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg. | Up to 12 years |
| Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment | Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy. | Up to 12 years |
| Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period. | Up to 1 year |
| The Duration of Treatment of Trastuzumab | Total treatment duration and duration of the first line of treatment is reported. | Up to 1 Year |
| Aix-en-Provence |
| 13616 |
| France |
| Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire | Aix-en-Provence | 13617 | France |
| Chd Castelluccio; Oncologie | Ajaccio | 20176 | France |
| Clinique De L Europe; Pmsi | Amiens | 80090 | France |
| Clinique De L Europe; Radiotherapie Chimiotherapie | Amiens | 80090 | France |
| HOP Prive Arras Les Bonnettes; Chimiotherapie | Arras | 62012 | France |
| Hopital Europeen La Roseraie;Radiotherapie | Aubervilliers | 93308 | France |
| Polyclinique Sainte Marguerite; Chimiotherapie | Auxerre | 89000 | France |
| Clinique Champeau Mediterranee; Radiotherapie Oncologie | Béziers | 34535 | France |
| Hopital Saint Andre; Oncologie 2 | Bordeaux | 33075 | France |
| Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie | Bordeaux | 33077 | France |
| Centre Hospitalier Fleyriat; Oncologie/Hematologie | Bourg-en-Bresse | 01012 | France |
| Hopital Augustin Morvan; Hopital De Jour | Brest | 29609 | France |
| Ch De Brive La Gaillarde; Radiotherapie Oncologie | Brive-la-Gaillarde | 19312 | France |
| Centre Francois Baclesse; Comite Sein | Caen | 14076 | France |
| Ch Antoine Gayraud; Oncologie | Carcassonne | 11890 | France |
| Clinique Montreal; Chimiotherapie | Carcassonne | France |
| Ch William Morey; Medecine 1 | Chalon-sur-Saône | 71321 | France |
| Centre Jean Perrin; Hopital De Jour | Clermont-Ferrand | 63011 | France |
| Pole Sante Republique;Oncologie Hematologie | Clermont-Ferrand | 63050 | France |
| Ch De Dax; Radiotherapie Oncologie | Dax | 40107 | France |
| Centre Leonard De Vinci;Chimiotherapie | Dechy | 59187 | France |
| Centre Georges Francois Leclerc; Oncologie 3 | Dijon | 21079 | France |
| Hopital Prive Drome Ardeche; Chir 2A 2B | Guilherand-Granges | 07500 | France |
| Clinique de L' Esperance; Oncologie | Hyères | 83400 | France |
| Polyclinique de Blois; Chimiotherapie Ambulatoire | La Chaussée-Saint-Victor | 41260 | France |
| CH Dptal Les Oudairies; Hematologie Oncologie | La Roche-sur-Yon | 85925 | France |
| Hopital Albert Michallon; Oncologie | La Tronche | 38700 | France |
| Polyclinique Du Bois; Centre Bourgogne | Lille | 59000 | France |
| Polyclinique Du Bois; Oncologie | Lille | 59003 | France |
| Ch De Longjumeau; Hopital De Jour Et Semaine | Longjumeau | 91161 | France |
| Clinique Des 4 Pavillons; Chimiotherapie | Lormont | 33310 | France |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Polyclinique Du Beaujolais; Chimiotherapie | Lyon | 69400 | France |
| Hopital Edouard Herriot; Pavillon F Rhumatologie | Lyon | 69437 | France |
| Hôpital Saint Joseph; Oncologie Medicale | Marseille | 13285 | France |
| Polyclinique Du Val De Saone; Chimiotherapie | Mâcon | 71000 | France |
| Ch De Montelimar; Radiotherapie | Montélimar | 26216 | France |
| Clinique Clementville; Hopital De Jour | Montpellier | 34070 | France |
| Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie | Montpellier | 34967 | France |
| Centre Azureen De Cancerologie; Cons externes | Mougins | 06250 | France |
| Hopital Emile Muller; Oncologie Radiotherapie | Mulhouse | 68070 | France |
| Centre D'Oncologie de Gentilly; Oncology | Nancy | 54100 | France |
| Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE | Nancy | 54100 | France |
| Clinique Des Genets; Radiotherapie | Narbonne | 11108 | France |
| Clinique Henry Hartmann; Oncologie | Neuilly-sur-Seine | 92200 | France |
| Centre Antoine Lacassagne; Hopital De Jour A2 | Nice | 06189 | France |
| Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie | Nîmes | 30029 | France |
| Polyclinique Kenval ; Radiotherapie Oncologie | Nîmes | 30900 | France |
| Clinique sainte marie; chimiotherapie ambulatoire | Osny | 95520 | France |
| Hopital Saint Louis; Oncologie Medicale | Paris | 75475 | France |
| Hopital Des Diaconesses; Hopital De Jour | Paris | 75571 | France |
| Ch Pitie Salpetriere; Oncologie Medicale | Paris | 75651 | France |
| HOPITAL TENON; Cancerologie Medicale | Paris | 75970 | France |
| Clinique Francheville; Radiotherapie | Périgueux | 24000 | France |
| Ch Lyon Sud; Hemato Secteur Jules Courmont | Pierre-Bénite | 69495 | France |
| Ch Lyon Sud; Onco Secteur Jules Courmont | Pierre-Bénite | 69495 | France |
| Ch De Pithiviers; Consult Externes | Pithiviers | 45307 | France |
| Institut Jean Godinot; Pavillon Rubis | Reims | 51056 | France |
| Polyclinique De Courlancy; Chimiotherapie Ambulatoire | Reims | 51057 | France |
| Centre Eugene Marquis; Unite Huguenin | Rennes | 35042 | France |
| Clinique Saint Hilaire; Sce Chimiotherapie | Rouen | 76044 | France |
| Chp Saint Gregoire; Cancerologie Radiotherapie | Saint-Grégoire | 35768 | France |
| Ico Rene Gauducheau; Oncologie | Saint-Herblain | 44805 | France |
| Clinique de L'Union; Oncologie | Saint-Jean | 31240 | France |
| Centre Radiotherapie Etienne Dolet | Saint-Nazaire | 44600 | France |
| Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0 | Saint-Priest-en-Jarez | 42271 | France |
| Ch De Saint Quentin; Medecine B10 | Saint-Quentin | 02321 | France |
| CH De Senlis; Medecine 2 | Senlis | 60309 | France |
| Ch De Soissons; Medecine Ambulatoire | Soissons | 02209 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Clinique Pasteur; Oncologie Medicale | Toulouse | 31076 | France |
| Chevelle Christian; Centre De Radiotherapie | Toulouse | France |
| Centre Alexis Vautrin; Oncologie Medicale | Vandœuvre-lès-Nancy | 54511 | France |
| Hopital Saint Nicolas; Pneumologie | Verdun | 55107 | France |
| Institut Gustave Roussy; Comite 5 | Villejuif | 94805 | France |
| Institut Gustave Roussy; Departement Oncologie Medicale | Villejuif | 94805 | France |
| Safety Set |
|
| Analysed Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analyzed set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab | Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year. |
| 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 | Tumor Hormone Receptor Status of Participants Without Progression | The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival. | Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment | Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported | Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 3 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice. | Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. | Posted | Median | 95% Confidence Interval | Years | Up to 12 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Progression | The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease. | Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. | Posted | Median | 95% Confidence Interval | Years | Up to 12 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause. | Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. | Posted | Median | 95% Confidence Interval | Years | Up to 12 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Dosage Schedule of Herceptin Treatment | Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg. | Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as 'n'. | Posted | Number | Participants | Up to 12 years |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment | Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy. | Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as 'n'. | Posted | Number | Participants | Up to 12 years |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period. | The safety population set included of all participants who received at least one dose of study drug. Participants with available data in the prospective period were analysed. | Posted | Number | Participants | Up to 1 year |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | The Duration of Treatment of Trastuzumab | Total treatment duration and duration of the first line of treatment is reported. | Analyzed Set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures. | Posted | Mean | Standard Deviation | Years | Up to 1 Year |
|
|
Up to 1 year
An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug .The data was reported for prospective period. Participants with available data in the prospective period were analysed.
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 | Trastuzumab | Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year. | 6 | 134 | 30 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraplegia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrioventricular extrasystoles | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cushing's syndrome | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cytolytic hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinobronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood glucose | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood sodium | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sciatic nerve neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| Mastectomy | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
| |
| Ischaemic limb pain | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vascular compression | Vascular disorders | MedDRA 14.0 | 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 | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| 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 |
|---|---|
| D000068878 | Trastuzumab |
| 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 |
Not provided
Not provided
|
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