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This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab emtansine 3.6 mg/kg | Experimental | Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab emtansine [Kadcyla] | Drug | Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) | Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. | Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) | For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Holden, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock Hem Onc Assoc | Little Rock | Arkansas | 72205 | United States | ||
| Rocky Mountain Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab Emtansine 3.6 mg/kg | Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) | Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) | Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) | For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response. | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) | Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| Denver |
| Colorado |
| 80220 |
| United States |
| Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Lynn Cancer Institute - West | Boca Raton | Florida | 33428 | United States |
| Florida Cancer Care | Davie | Florida | 33328 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Hem/Onc Assoc - Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Gulfcoast Oncology Associates | St. Petersburg | Florida | 33705 | United States |
| Bay Area Oncology | Tampa | Florida | 33607 | United States |
| Northwest Georgia Onc Ctrs PC | Marietta | Georgia | 30060 | United States |
| John McClean, M.D. - Private P | Galesburg | Illinois | 61401 | United States |
| Cedar Valley Med Specialists | Waterloo | Iowa | 50702 | United States |
| Kentuckiana Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Minnesota Oncology Hematology, | Minneapolis | Minnesota | 55404 | United States |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | United States |
| Kansas City Cancer Center, LLC | Lee's Summit | Missouri | 64064 | United States |
| St. Louis Cancer & Breast Inst | St Louis | Missouri | 63141 | United States |
| St. Barnabas Health Care Sys | Livingston | New Jersey | 07039 | United States |
| New York Oncology Hematology | Albany | New York | 12206 | United States |
| Eastchester Center/Cancer Care | The Bronx | New York | 10469 | United States |
| Carolinas Hem-Oncology Assoc | Charlotte | North Carolina | 28203 | United States |
| Raleigh Hemotology & Oncology | Raleigh | North Carolina | 27607 | United States |
| Midwestern Regional Med Center | Eugene | Oregon | 97401-8122 | United States |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | United States |
| Texas Oncology, P.A. | Bedford | Texas | 76022 | United States |
| Cancer Specialists of South Te | Corpus Christi | Texas | 78412 | United States |
| US Oncology Research, Inc. | Dallas | Texas | 75204 | United States |
| USO | Dallas | Texas | 75230-2510 | United States |
| Texas Oncology, P.A. | Dallas | Texas | 75231-4400 | United States |
| Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| El Paso Cancer Treatment Ctr | El Paso | Texas | 79915 | United States |
| Texas Oncology PA | Fort Worth | Texas | 76104 | United States |
| Texas Oncology, P.A. | Houston | Texas | 77024-2305 | United States |
| US Oncology | Midland | Texas | 79701 | United States |
| USO - Tyler Cancer Ctr | Tyler | Texas | 75702 | United States |
| Waco Cancer Care & Research Ce | Waco | Texas | 76712 | United States |
| Northern Utah Associates | Ogden | Utah | 84403 | United States |
| Fairfax N Virginia Hem/Onc PC | Fairfax | Virginia | 22031 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Northwest Cancer Specialists | Vancouver | Washington | 98684 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab Emtansine 3.6 mg/kg | Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle. |
| 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 | Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) | Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. | Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of patients | Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months) |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) | For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response. | Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) | Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. | Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) | Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. | Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of patients | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) | For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response. | Patients who had an objective response in the efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) | Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. | Efficacy evaluable population: All patients who received at least 1 dose of study drug and who underwent a baseline and at least 1 post-baseline tumor assessment or died while in the study from any cause within 30 days of the last dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) |
|
Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
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 Emtansine 3.6 mg/kg | Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle. | 30 | 112 | 110 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (11.1) | 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 |
| 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 |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| 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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