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Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab emtansine | Experimental | Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab emtansine [Kadcyla] | Drug | Intravenous repeating dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review | Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions. PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) 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 nontarget lesions. The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled). | From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled). |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Objective Response as Assessed Through Independent Radiologic Review | For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was assessed by the independent review facility. 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget 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 |
|---|---|---|
| Ellie Guardino, M.D., PhD. | Genentech, Inc. | Study Director |
Not provided
Between 13 August 2008 and 2 April 2009, 110 patients from 44 study sites in the United States were enrolled and treated in the study.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab Emtansine | Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab Emtansine | Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 an Objective Response as Assessed Through Independent Radiologic Review | Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions. PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) 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 nontarget lesions. The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled). | Treated population (patients who received at least one dose of T-DM1). Participants without a post-baseline tumor assessment were considered to be non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled). |
From the date of first dose until 26 April 2011, approximately 25 months of follow-up.
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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 | Trastuzumab Emtansine | Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 |
Not provided
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| From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
| Progression-free Survival as Assessed Through Independent Radiologic Review | Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Disease progression was assessed by the independent review facility. 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. | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
| Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review | Clinical benefit was defined as participants who achieved an objective response (confirmed complete or partial response) between randomization and 1 January 2010, or with stable disease at 6 months. Stable disease at 6 months was defined as participants who achieved at least stable disease based on tumor assessments by the independent review facility, and remained alive and progression-free at 6 months. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, and no new lesions and/or unequivocal progression of existing nontarget lesions. Response was assessed by the independent review facility. | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
| Objective Response Based on Investigator Assessment | Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Response was assessed by the study Investigator. CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions. PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) 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 nontarget lesions. | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
| Progression-free Survival Based on Investigator Assessment | Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget 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. | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
| Duration of Objective Response Based on Investigator Assessment | For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was determined by the Investigator's assessment. 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget 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. | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
| Percentage of Participants With Clinical Benefit Based on Investigator Assessment | Clinical benefit was defined as participants with an objective response (confirmed complete or partial response) or stable disease at 6 months. Patients with stable disease at 6 months were defined as patients who achieved at least stable disease based on tumor assessments and remained alive and progression free at 6 months. Response was based on the Investigator's assessment. | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
| Physician Decision |
|
| Refused to undergo protocol procedures |
|
| Transferred to extension study TDM4529g |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Duration of Objective Response as Assessed Through Independent Radiologic Review | For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was assessed by the independent review facility. 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget 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. | Participants with an objective response. | Posted | Median | 95% Confidence Interval | months | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
|
|
|
| Secondary | Progression-free Survival as Assessed Through Independent Radiologic Review | Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions. Disease progression was assessed by the independent review facility. 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. | Treated population. | Posted | Median | 95% Confidence Interval | months | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
|
|
|
| Secondary | Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review | Clinical benefit was defined as participants who achieved an objective response (confirmed complete or partial response) between randomization and 1 January 2010, or with stable disease at 6 months. Stable disease at 6 months was defined as participants who achieved at least stable disease based on tumor assessments by the independent review facility, and remained alive and progression-free at 6 months. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, and no new lesions and/or unequivocal progression of existing nontarget lesions. Response was assessed by the independent review facility. | Treated population. Participants without a post-baseline tumor assessment were considered to have experienced no clinical benefit. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
|
|
|
| Secondary | Objective Response Based on Investigator Assessment | Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Response was assessed by the study Investigator. CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions. PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) 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 nontarget lesions. | Treated population. Participants without a post-baseline tumor assessment were considered to be non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
|
|
|
| Secondary | Progression-free Survival Based on Investigator Assessment | Progression-Free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (i.e., 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget 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. | Treated population | Posted | Median | 95% Confidence Interval | months | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
|
|
|
| Secondary | Duration of Objective Response Based on Investigator Assessment | For participants who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a participant's objective response to the time of disease progression or death on study (i.e., death from any cause within 30 days of the last dose of study drug), whichever occurred first. Response was determined by the Investigator's assessment. 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 one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget 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. | Participants with an objective response. | Posted | Median | 95% Confidence Interval | months | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
|
|
|
| Secondary | Percentage of Participants With Clinical Benefit Based on Investigator Assessment | Clinical benefit was defined as participants with an objective response (confirmed complete or partial response) or stable disease at 6 months. Patients with stable disease at 6 months were defined as patients who achieved at least stable disease based on tumor assessments and remained alive and progression free at 6 months. Response was based on the Investigator's assessment. | Treated population. Patients without a post-baseline tumor assessment were considered to have experienced no clinical benefit. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled. |
|
|
|
| 29 |
| 110 |
| 105 |
| 110 |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Axillary pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Blood culture positive | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Central nervous system necrosis | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Blood lactate dehydrogenase increase | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (12.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (12.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.1) | 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.
| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |