Trial Outcomes & Findings for A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (NCT NCT00509769)
NCT ID: NCT00509769
Last Updated: 2013-04-02
Results Overview
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.
COMPLETED
PHASE2
112 participants
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)
2013-04-02
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
91
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Progressive disease
|
77
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Patient's decision
|
1
|
|
Overall Study
Physician Decision
|
8
|
|
Overall Study
Use of prohibited therapies during study
|
1
|
Baseline Characteristics
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=112 Participants
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.
|
|---|---|
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Age Continuous
|
55.0 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=109 Participants
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.
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|---|---|
|
Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
Month 6 (n=109)
|
25.7 Percentage of patients
Interval 17.9 to 34.5
|
|
Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
Month 12 (n=108)
|
26.9 Percentage of patients
Interval 19.2 to 35.8
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=108 Participants
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.
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|---|---|
|
Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
NA Months
Interval 6.2 to
The median and the upper limit of the 95% confidence interval were not reached because of insufficient events.
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=108 Participants
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.
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|---|---|
|
Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
4.6 Months
Interval 3.9 to 8.6
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=108 Participants
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.
|
|---|---|
|
Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
38.9 Percentage of patients
Interval 29.7 to 48.5
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=108 Participants
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.
|
|---|---|
|
Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
9.4 Months
Interval 7.0 to
The upper limit of the 95% confidence interval were not reached because of insufficient events.
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=108 Participants
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.
|
|---|---|
|
Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
|
4.6 Months
Interval 4.1 to 6.0
|
Adverse Events
Trastuzumab Emtansine 3.6 mg/kg
Serious adverse events
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=112 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Dysphagia
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Asthenia
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Disease progression
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Infections and infestations
Cellulitis
|
2.7%
3/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Infections and infestations
Pneumonia
|
1.8%
2/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Infections and infestations
Osteomyelitis
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Infections and infestations
Urosepsis
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Investigations
Hepatic enzyme increased
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Investigations
Platelet count decreased
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Investigations
White blood cell count increased
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
2/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Nervous system disorders
Convulsion
|
1.8%
2/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Nervous system disorders
Altered state of consciousness
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Nervous system disorders
Aphasia
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Psychiatric disorders
Confusional state
|
1.8%
2/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
2/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Vascular disorders
Deep vein thrombosis
|
0.89%
1/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
Other adverse events
| Measure |
Trastuzumab Emtansine 3.6 mg/kg
n=112 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.5%
23/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.1%
18/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
7/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Eye disorders
Dry eye
|
9.8%
11/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Eye disorders
Lacrimation increased
|
8.0%
9/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Eye disorders
Vision blurred
|
5.4%
6/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Eye disorders
Visual impairment
|
5.4%
6/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Nausea
|
50.9%
57/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Constipation
|
30.4%
34/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.9%
29/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Vomiting
|
24.1%
27/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
16/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
12/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.7%
12/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
9/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
8/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.4%
6/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Fatigue
|
65.2%
73/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Pyrexia
|
34.8%
39/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Chills
|
19.6%
22/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Pain
|
11.6%
13/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Oedema peripheral
|
10.7%
12/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Chest pain
|
8.9%
10/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Asthenia
|
6.2%
7/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Influenza like illness
|
6.2%
7/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
General disorders
Infusion related reaction
|
6.2%
7/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.9%
20/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Infections and infestations
Urinary tract infection
|
16.1%
18/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Injury, poisoning and procedural complications
Contusion
|
10.7%
12/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Investigations
Weight decreased
|
11.6%
13/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
24.1%
27/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Metabolism and nutrition disorders
Anorexia
|
19.6%
22/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
16/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
6/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.3%
25/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
24/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
14/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.6%
13/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
11/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.9%
10/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.0%
9/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
8/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.4%
6/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Nervous system disorders
Headache
|
40.2%
45/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Nervous system disorders
Neuropathy peripheral
|
17.9%
20/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Nervous system disorders
Dizziness
|
11.6%
13/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
7/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Psychiatric disorders
Insomnia
|
13.4%
15/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Psychiatric disorders
Depression
|
12.5%
14/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Psychiatric disorders
Anxiety
|
10.7%
12/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Psychiatric disorders
Confusional state
|
6.2%
7/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
35.7%
40/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.7%
31/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.5%
23/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.0%
9/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
8/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.0%
19/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
8/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Vascular disorders
Hypertension
|
6.2%
7/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
|
Vascular disorders
Hot flush
|
5.4%
6/112 • Adverse events were recorded from randomization through the end of the study.
Safety population: All patients who received any amount of trastuzumab emtansine.
|
Additional Information
Medical Communications
Genentech, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER