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A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

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ClinicalTrials.gov Identifier: NCT01702571
Recruitment Status : Completed
First Posted : October 8, 2012
Results First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Trastuzumab Emtansine
Enrollment 2185
Recruitment Details Cohort 1 has 2003 participants and Cohort 2 has 182 participants representing the total enrollment study number. Cohort 1 was conducted in 281 centers in 40 countries worldwide whereas Cohort 2 was conducted in an Asian population in 14 centers in China, Thailand and Indonesia.
Pre-assignment Details Two participants (one in Corhort 1 and Corhot 2) were not included in the safety population as one didn't receive study treatment and one did not qualify under the inclusion criteria.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression. This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Period Title: Overall Study
Started 2003 182
Completed 494 [1] 65
Not Completed 1509 117
Reason Not Completed
Death             1067             76
Lost to Follow-up             144             10
Adverse Event/Unacceptable Toxicity             4             0
Investigator Decision             5             0
Not Classifiable             1             0
On Study Treatment At Lplv/Cohort 1             93             0
On Study Treatment At Lplv/Cohort 2             0             1
Progressive Disease             3             0
Protocol Violation             2             0
Safety FU Done < 3 Months Prior To CCOD             9             1
Termination By Sponsor             4             0
Withdrawal by Subject             177             29
[1]
For one participant, the site incorrectly answered the question 'Did the participant complete follow-up as per protocol?' It was answered No, however the participant was in survival follow-up and the site should have answered Yes. This participant is wrongly counted in the 'discontinued from study' number.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants) Total
Hide Arm/Group Description This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression. This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression. Total of all reporting groups
Overall Number of Baseline Participants 2003 182 2185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2003 participants 182 participants 2185 participants
54.5  (11.4) 49.1  (10.1) 54.1  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2003 participants 182 participants 2185 participants
Female
1989
  99.3%
182
 100.0%
2171
  99.4%
Male
14
   0.7%
0
   0.0%
14
   0.6%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2003 participants 182 participants 2185 participants
Caucasian 1397 0 1397
Black 21 0 21
Asian 72 182 254
Native American 41 0 41
N/A as per local regulation 466 0 466
Unknown 3 0 3
Other 2 0 2
Missing 1 0 1
[1]
Measure Description: Race
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2003 participants 182 participants 2185 participants
Hispanic/Latino 300 0 300
Chinese 29 147 176
N/A as per local regulation 997 16 1013
Other 417 19 436
Mixed 9 0 9
Indian (Indian subcontinent) 4 0 4
Unknown 247 0 247
[1]
Measure Description: Ethnicity
1.Primary Outcome
Title Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
Hide Description The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
Time Frame Baseline up to approximately 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who had received at least 1 dose of study medication.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 2002 181
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
23.1
(21.2 to 25.0)
51.4
(43.9 to 58.9)
2.Secondary Outcome
Title Percentage of Participants With Specific AEPIs
Hide Description The AEPIs in this study were defined as the following: adverse events (AEs) Grade >/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade >/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
Time Frame Baseline up to approximately 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who had received at least 1 dose of study medication.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 2002 181
Measure Type: Number
Unit of Measure: Percentage of Participants
AEs Grade >/= 3 for hepatic events 6.9 12.2
AEs Grade >/= 3 for allergic reactions 2.3 1.1
AEs Grade >/= 3 for thrombocytopenia 3.7 36.5
AEs Grade >/= 3 for hemorrhage events 2.3 1.7
AEs Grade >/= 3 related to trastuzumab emtansine 18.4 48.6
Pneumonitis of all grades 1.0 2.2
3.Secondary Outcome
Title Percentage of Participants With Adverse Events of Special Interest (AESIs)
Hide Description AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were >3 × ULN, Concurrent elevation of total bilirubin >2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin >2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.
Time Frame Baseline up to approximately 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who had received at least 1 dose of study medication.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 2002 181
Measure Type: Number
Unit of Measure: Percentage of Participants
Potential drug-induced liver injury 1.2 1.1
Suspected transmission of an infectious agent 0.2 0.0
4.Secondary Outcome
Title Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
Hide Description Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
Time Frame Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population included all participants enrolled in the study.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 2003 182
Median (95% Confidence Interval)
Unit of Measure: months
6.8
(5.8 to 7.6)
5.7
(5.5 to 7.0)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.
Time Frame Baseline until death (up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants enrolled in the study.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 2003 182
Median (95% Confidence Interval)
Unit of Measure: months
27.2
(25.5 to 28.7)
29.5 [1] 
(21.1 to NA)
[1]
The confidence interval has no upper limit
6.Secondary Outcome
Title Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
Hide Description Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time Frame Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 1613 169
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
29.3
(27.1 to 31.6)
29.6
(22.8 to 37.1)
7.Secondary Outcome
Title Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1
Hide Description Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
Time Frame Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 1613 169
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
47.1
(44.7 to 49.6)
39.6
(32.2 to 47.4)
8.Secondary Outcome
Title Duration of Response (DOR) According to RECIST v 1.1
Hide Description DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm).
Time Frame Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 1613 169
Median (95% Confidence Interval)
Unit of Measure: months
13.8
(12.2 to 15.0)
14.2
(11.1 to 24.4)
9.Secondary Outcome
Title Time to Response According to RECIST v 1.1
Hide Description Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time Frame Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants enrolled in the study. Only responders were included in the analysis.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 473 50
Median (95% Confidence Interval)
Unit of Measure: months
22.3
(11.8 to 38.2)
8.3 [1] 
(5.7 to NA)
[1]
The confidence interval has no upper limit
10.Secondary Outcome
Title Number of Hospital Visits
Hide Description The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.
Time Frame Baseline up to approximately 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who had received at least 1 dose of study medication.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 2002 181
Mean (Standard Deviation)
Unit of Measure: Number of Hospital Visits
2.7  (2.78) 2.1  (1.70)
11.Secondary Outcome
Title Type of Hospital Visits
Hide Description The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.
Time Frame Baseline up to approximately 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who had received at least 1 dose of study medication.
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description:
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
Overall Number of Participants Analyzed 2002 181
Measure Type: Number
Unit of Measure: Participants
Other Hospital Visit Number Analyzed 2002 participants 181 participants
558 33
ICU Visit Number Analyzed 558 participants 33 participants
39 0
Time Frame Baseline up to approximately 7 years
Adverse Event Reporting Description The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
 
Arm/Group Title Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Hide Arm/Group Description This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression. This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
All-Cause Mortality
Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Affected / at Risk (%) Affected / at Risk (%)
Total   1072/2002 (53.55%)      77/181 (42.54%)    
Hide Serious Adverse Events
Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   427/2002 (21.33%)      36/181 (19.89%)    
Blood and lymphatic system disorders     
ANAEMIA  1  13/2002 (0.65%)  14 0/181 (0.00%)  0
BONE MARROW FAILURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
DISSEMINATED INTRAVASCULAR COAGULATION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
FEBRILE NEUTROPENIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
THROMBOCYTOPENIA  1  11/2002 (0.55%)  11 10/181 (5.52%)  11
Cardiac disorders     
ACUTE CORONARY SYNDROME  1  3/2002 (0.15%)  3 1/181 (0.55%)  1
ANGINA PECTORIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CARDIAC ARREST  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CARDIAC FAILURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CARDIAC TAMPONADE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CARDIO-RESPIRATORY ARREST  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PALPITATIONS  1  1/2002 (0.05%)  1 1/181 (0.55%)  1
PERICARDIAL EFFUSION  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
Ear and labyrinth disorders     
VERTIGO  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
Endocrine disorders     
ADRENAL INSUFFICIENCY  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HYPERTHYROIDISM  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Eye disorders     
BLINDNESS  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
CATARACT  1  0/2002 (0.00%)  0 1/181 (0.55%)  1
RETINAL VEIN THROMBOSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ABDOMINAL PAIN  1  4/2002 (0.20%)  12 1/181 (0.55%)  1
ABDOMINAL PAIN UPPER  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
ANAL FISSURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ANAL HAEMORRHAGE  1  2/2002 (0.10%)  4 0/181 (0.00%)  0
ASCITES  1  2/2002 (0.10%)  6 0/181 (0.00%)  0
COLITIS  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
CONSTIPATION  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
DIARRHOEA  1  4/2002 (0.20%)  4 0/181 (0.00%)  0
DUODENAL ULCER  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
DUODENAL ULCER HAEMORRHAGE  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
DYSPHAGIA  1  2/2002 (0.10%)  3 0/181 (0.00%)  0
GASTRIC ANTRAL VASCULAR ECTASIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GASTRIC HAEMORRHAGE  1  1/2002 (0.05%)  10 0/181 (0.00%)  0
GASTRIC ULCER  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GASTRITIS  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
GASTRITIS EROSIVE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GASTRODUODENAL ULCER  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  3/2002 (0.15%)  10 0/181 (0.00%)  0
GINGIVAL BLEEDING  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GLOSSITIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
INTESTINAL OBSTRUCTION  1  2/2002 (0.10%)  3 0/181 (0.00%)  0
LOWER GASTROINTESTINAL HAEMORRHAGE  1  1/2002 (0.05%)  2 1/181 (0.55%)  2
MELAENA  1  2/2002 (0.10%)  8 0/181 (0.00%)  0
NAUSEA  1  5/2002 (0.25%)  6 1/181 (0.55%)  1
OESOPHAGEAL FISTULA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
OESOPHAGEAL VARICES HAEMORRHAGE  1  1/2002 (0.05%)  4 0/181 (0.00%)  0
PANCREATITIS ACUTE  1  1/2002 (0.05%)  3 0/181 (0.00%)  0
PERIODONTAL DISEASE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PROCTALGIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
RECTAL HAEMORRHAGE  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
SMALL INTESTINAL HAEMORRHAGE  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
STOMATITIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SUBILEUS  1  2/2002 (0.10%)  4 0/181 (0.00%)  0
TOOTH LOSS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
UPPER GASTROINTESTINAL HAEMORRHAGE  1  3/2002 (0.15%)  6 2/181 (1.10%)  6
VOMITING  1  17/2002 (0.85%)  19 1/181 (0.55%)  1
General disorders     
ASTHENIA  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
CATHETER SITE ERYTHEMA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CHILLS  1  2/2002 (0.10%)  6 0/181 (0.00%)  0
DEATH  1  5/2002 (0.25%)  5 0/181 (0.00%)  0
FATIGUE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GENERAL PHYSICAL HEALTH DETERIORATION  1  4/2002 (0.20%)  4 0/181 (0.00%)  0
HYPERTHERMIA  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
IMPLANT SITE DEHISCENCE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
INFLAMMATION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
INFLUENZA LIKE ILLNESS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
MALAISE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
MULTIPLE ORGAN DYSFUNCTION SYNDROME  1  3/2002 (0.15%)  3 1/181 (0.55%)  1
PYREXIA  1  13/2002 (0.65%)  42 0/181 (0.00%)  0
SUDDEN DEATH  1  0/2002 (0.00%)  0 1/181 (0.55%)  1
Hepatobiliary disorders     
CHOLECYSTITIS  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
CHOLESTASIS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
DRUG-INDUCED LIVER INJURY  1  1/2002 (0.05%)  3 1/181 (0.55%)  3
HEPATIC FAILURE  1  5/2002 (0.25%)  10 0/181 (0.00%)  0
HEPATIC FUNCTION ABNORMAL  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HEPATIC PAIN  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HEPATOTOXICITY  1  7/2002 (0.35%)  14 0/181 (0.00%)  0
JAUNDICE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
NODULAR REGENERATIVE HYPERPLASIA  1  3/2002 (0.15%)  6 0/181 (0.00%)  0
NON-CIRRHOTIC PORTAL HYPERTENSION  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
PORTAL HYPERTENSION  1  2/2002 (0.10%)  4 0/181 (0.00%)  0
Immune system disorders     
ALLERGIC OEDEMA  1  1/2002 (0.05%)  3 0/181 (0.00%)  0
HYPERSENSITIVITY  1  2/2002 (0.10%)  6 0/181 (0.00%)  0
Infections and infestations     
ABSCESS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ACINETOBACTER INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ARTHRITIS INFECTIVE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BACTERAEMIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BACTERIAL INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BACTERIAL SEPSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BRAIN ABSCESS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BREAST CELLULITIS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
BRONCHITIS  1  3/2002 (0.15%)  4 0/181 (0.00%)  0
CATHETER SITE INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CELLULITIS  1  8/2002 (0.40%)  10 0/181 (0.00%)  0
CLOSTRIDIUM DIFFICILE COLITIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CYSTITIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
DENGUE HAEMORRHAGIC FEVER  1  0/2002 (0.00%)  0 1/181 (0.55%)  1
DEVICE RELATED INFECTION  1  6/2002 (0.30%)  6 0/181 (0.00%)  0
ENCEPHALITIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ENDOCARDITIS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
ERYSIPELAS  1  4/2002 (0.20%)  5 0/181 (0.00%)  0
GASTROENTERITIS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
GASTROENTERITIS NOROVIRUS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GASTROENTERITIS VIRAL  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GASTROINTESTINAL VIRAL INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HERPES ZOSTER  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
INFECTION  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
INFECTIOUS PLEURAL EFFUSION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
INFECTIVE EXACERBATION OF BRONCHIECTASIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
INTERVERTEBRAL DISCITIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
KLEBSIELLA BACTERAEMIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
LISTERIOSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
LIVER ABSCESS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
LOWER RESPIRATORY TRACT INFECTION  1  9/2002 (0.45%)  10 0/181 (0.00%)  0
MASTITIS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
MENINGITIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
OTITIS MEDIA  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
PERITONITIS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
PHARYNGITIS  1  1/2002 (0.05%)  1 1/181 (0.55%)  1
PNEUMOCOCCAL INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PNEUMONIA  1  22/2002 (1.10%)  23 8/181 (4.42%)  8
PNEUMONIA STREPTOCOCCAL  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PNEUMONIA VIRAL  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PYELONEPHRITIS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
PYELONEPHRITIS ACUTE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PYELONEPHRITIS CHRONIC  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
RESPIRATORY TRACT INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
RESPIRATORY TRACT INFECTION VIRAL  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SEPSIS  1  9/2002 (0.45%)  9 0/181 (0.00%)  0
SEPTIC SHOCK  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SKIN INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SOFT TISSUE INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
STAPHYLOCOCCAL BACTERAEMIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
STAPHYLOCOCCAL INFECTION  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
STAPHYLOCOCCAL SEPSIS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
STREPTOCOCCAL INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
TRACHEOBRONCHITIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  3/2002 (0.15%)  4 0/181 (0.00%)  0
URINARY TRACT INFECTION  1  11/2002 (0.55%)  12 0/181 (0.00%)  0
VASCULAR DEVICE INFECTION  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
VIRAL INFECTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
VULVAL ABSCESS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Injury, poisoning and procedural complications     
ANASTOMOTIC ULCER  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ANKLE FRACTURE  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
FALL  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
FEMORAL NECK FRACTURE  1  4/2002 (0.20%)  4 0/181 (0.00%)  0
FEMUR FRACTURE  1  8/2002 (0.40%)  8 0/181 (0.00%)  0
FOREARM FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HAND FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HEAD INJURY  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
HIP FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HUMERUS FRACTURE  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
INFUSION RELATED REACTION  1  2/2002 (0.10%)  6 0/181 (0.00%)  0
INTENTIONAL OVERDOSE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
LUMBAR VERTEBRAL FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PELVIC FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
POST PROCEDURAL HAEMORRHAGE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
RADIATION NECROSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
RIB FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ROAD TRAFFIC ACCIDENT  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SKELETAL INJURY  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SPLENIC INJURY  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SUBDURAL HAEMATOMA  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
THERMAL BURN  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
UPPER LIMB FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
WRIST FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
AMYLASE INCREASED  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ASPARTATE AMINOTRANSFERASE INCREASED  1  3/2002 (0.15%)  4 0/181 (0.00%)  0
BLOOD BILIRUBIN INCREASED  1  2/2002 (0.10%)  2 1/181 (0.55%)  1
ECG SIGNS OF MYOCARDIAL ISCHAEMIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HEPATIC ENZYME INCREASED  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
LIVER FUNCTION TEST ABNORMAL  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
LIVER FUNCTION TEST INCREASED  1  0/2002 (0.00%)  0 1/181 (0.55%)  1
NEUTROPHIL COUNT DECREASED  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PLATELET COUNT DECREASED  1  2/2002 (0.10%)  2 8/181 (4.42%)  12
TRANSAMINASES INCREASED  1  0/2002 (0.00%)  0 1/181 (0.55%)  1
Metabolism and nutrition disorders     
DECREASED APPETITE  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
DEHYDRATION  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
FAILURE TO THRIVE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HYPERCALCAEMIA  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
HYPERURICAEMIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HYPOGLYCAEMIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HYPOKALAEMIA  1  1/2002 (0.05%)  1 1/181 (0.55%)  2
HYPONATRAEMIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
BACK PAIN  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BONE LESION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BONE PAIN  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
HAEMATOMA MUSCLE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
INTERVERTEBRAL DISC PROTRUSION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
KYPHOSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
MOBILITY DECREASED  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
MUSCULAR WEAKNESS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
MUSCULOSKELETAL CHEST PAIN  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
OSTEONECROSIS OF JAW  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PAIN IN EXTREMITY  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
PATHOLOGICAL FRACTURE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SPINAL PAIN  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
SYSTEMIC LUPUS ERYTHEMATOSUS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BASAL CELL CARCINOMA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BENIGN NEOPLASM  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BREAST CANCER METASTATIC  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CANCER PAIN  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
MALIGNANT MELANOMA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
MENINGIOMA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
METASTASES TO BONE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
METASTATIC UTERINE CANCER  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
NAEVUS HAEMORRHAGE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SARCOMA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SKIN NEOPLASM BLEEDING  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Nervous system disorders     
APHASIA  1  2/2002 (0.10%)  4 0/181 (0.00%)  0
ATAXIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
BRAIN OEDEMA  1  6/2002 (0.30%)  7 0/181 (0.00%)  0
CENTRAL NERVOUS SYSTEM NECROSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CEREBRAL HAEMORRHAGE  1  4/2002 (0.20%)  8 1/181 (0.55%)  2
CEREBRAL ISCHAEMIA  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
CEREBROVASCULAR ACCIDENT  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
DIZZINESS  1  3/2002 (0.15%)  4 0/181 (0.00%)  0
EPILEPSY  1  8/2002 (0.40%)  15 0/181 (0.00%)  0
HAEMORRHAGE INTRACRANIAL  1  3/2002 (0.15%)  6 0/181 (0.00%)  0
HAEMORRHAGIC STROKE  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
HEADACHE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HEMIPARESIS  1  5/2002 (0.25%)  5 0/181 (0.00%)  0
IIIRD NERVE PARESIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
LEUKOENCEPHALOPATHY  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
MIGRAINE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
MOTOR DYSFUNCTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
NERVOUS SYSTEM DISORDER  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PARTIAL SEIZURES  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PRESYNCOPE  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
SCIATICA  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
SEIZURE  1  7/2002 (0.35%)  11 0/181 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
VOCAL CORD PARALYSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Product Issues     
DEVICE BREAKAGE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
DEVICE EXTRUSION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
DEVICE LOOSENING  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Psychiatric disorders     
AGITATION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ANXIETY  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
COMPLETED SUICIDE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CONFUSIONAL STATE  1  4/2002 (0.20%)  4 0/181 (0.00%)  0
DEPRESSION  1  3/2002 (0.15%)  4 0/181 (0.00%)  0
HALLUCINATION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Renal and urinary disorders     
ACUTE KIDNEY INJURY  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HAEMATURIA  1  2/2002 (0.10%)  4 0/181 (0.00%)  0
NEPHROLITHIASIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
RENAL COLIC  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
RENAL FAILURE  1  4/2002 (0.20%)  4 0/181 (0.00%)  0
RENAL INJURY  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
URINARY TRACT OBSTRUCTION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Reproductive system and breast disorders     
CYSTOCELE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
METRORRHAGIA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
UTERINE HAEMORRHAGE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
UTERINE POLYP  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
VAGINAL HAEMORRHAGE  1  1/2002 (0.05%)  1 1/181 (0.55%)  1
Respiratory, thoracic and mediastinal disorders     
ACUTE PULMONARY OEDEMA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ASPIRATION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
ASTHMATIC CRISIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
CHOKING  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
DYSPNOEA  1  7/2002 (0.35%)  24 0/181 (0.00%)  0
EPISTAXIS  1  7/2002 (0.35%)  8 0/181 (0.00%)  0
HAEMOPTYSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
INTERSTITIAL LUNG DISEASE  1  4/2002 (0.20%)  4 0/181 (0.00%)  0
PLEURAL EFFUSION  1  3/2002 (0.15%)  4 0/181 (0.00%)  0
PLEURITIC PAIN  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
PNEUMONITIS  1  6/2002 (0.30%)  6 0/181 (0.00%)  0
PNEUMOTHORAX  1  5/2002 (0.25%)  5 0/181 (0.00%)  0
PULMONARY ALVEOLAR HAEMORRHAGE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PULMONARY EMBOLISM  1  3/2002 (0.15%)  3 0/181 (0.00%)  0
PULMONARY FIBROSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
PULMONARY OEDEMA  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
RESPIRATORY DISTRESS  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
RESPIRATORY FAILURE  1  1/2002 (0.05%)  1 1/181 (0.55%)  1
RESPIRATORY TRACT HAEMORRHAGE  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SLEEP APNOEA SYNDROME  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Skin and subcutaneous tissue disorders     
SPIDER NAEVUS  1  1/2002 (0.05%)  2 0/181 (0.00%)  0
Surgical and medical procedures     
BREAST CONSERVING SURGERY  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
SCAR EXCISION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
Vascular disorders     
CIRCULATORY COLLAPSE  1  1/2002 (0.05%)  3 0/181 (0.00%)  0
EMBOLISM  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
HAEMATOMA  1  2/2002 (0.10%)  2 0/181 (0.00%)  0
HYPOTENSION  1  1/2002 (0.05%)  3 0/181 (0.00%)  0
ORTHOSTATIC HYPOTENSION  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
VENA CAVA THROMBOSIS  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
VENOUS THROMBOSIS LIMB  1  1/2002 (0.05%)  1 0/181 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab Emtansine (All Participants) Trastuzumab Emtansine (Asian Participants)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1734/2002 (86.61%)      170/181 (93.92%)    
Blood and lymphatic system disorders     
ANAEMIA  1  173/2002 (8.64%)  231 27/181 (14.92%)  49
LEUKOPENIA  1  19/2002 (0.95%)  23 15/181 (8.29%)  69
NEUTROPENIA  1  79/2002 (3.95%)  151 17/181 (9.39%)  72
THROMBOCYTOPENIA  1  165/2002 (8.24%)  257 47/181 (25.97%)  157
Gastrointestinal disorders     
ABDOMINAL PAIN  1  139/2002 (6.94%)  182 6/181 (3.31%)  8
ABDOMINAL PAIN UPPER  1  135/2002 (6.74%)  163 5/181 (2.76%)  5
CONSTIPATION  1  394/2002 (19.68%)  568 10/181 (5.52%)  38
DIARRHOEA  1  252/2002 (12.59%)  376 9/181 (4.97%)  9
DRY MOUTH  1  283/2002 (14.14%)  303 7/181 (3.87%)  13
GINGIVAL BLEEDING  1  83/2002 (4.15%)  96 14/181 (7.73%)  19
NAUSEA  1  651/2002 (32.52%)  1204 28/181 (15.47%)  45
STOMATITIS  1  160/2002 (7.99%)  213 4/181 (2.21%)  6
VOMITING  1  294/2002 (14.69%)  408 17/181 (9.39%)  24
General disorders     
ASTHENIA  1  491/2002 (24.53%)  828 18/181 (9.94%)  44
FATIGUE  1  556/2002 (27.77%)  846 12/181 (6.63%)  17
INFLUENZA LIKE ILLNESS  1  107/2002 (5.34%)  161 3/181 (1.66%)  3
OEDEMA PERIPHERAL  1  102/2002 (5.09%)  115 6/181 (3.31%)  10
PAIN  1  85/2002 (4.25%)  92 10/181 (5.52%)  11
PYREXIA  1  339/2002 (16.93%)  1599 47/181 (25.97%)  243
Infections and infestations     
NASOPHARYNGITIS  1  136/2002 (6.79%)  195 8/181 (4.42%)  13
UPPER RESPIRATORY TRACT INFECTION  1  80/2002 (4.00%)  107 14/181 (7.73%)  18
URINARY TRACT INFECTION  1  157/2002 (7.84%)  230 4/181 (2.21%)  4
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  86/2002 (4.30%)  100 58/181 (32.04%)  133
ASPARTATE AMINOTRANSFERASE INCREASED  1  136/2002 (6.79%)  156 77/181 (42.54%)  143
BLOOD ALKALINE PHOSPHATASE INCREASED  1  52/2002 (2.60%)  52 14/181 (7.73%)  16
BLOOD BILIRUBIN INCREASED  1  89/2002 (4.45%)  171 30/181 (16.57%)  85
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  84/2002 (4.20%)  94 21/181 (11.60%)  31
NEUTROPHIL COUNT DECREASED  1  36/2002 (1.80%)  58 20/181 (11.05%)  84
PLATELET COUNT DECREASED  1  91/2002 (4.55%)  124 55/181 (30.39%)  191
TRANSAMINASES INCREASED  1  27/2002 (1.35%)  28 18/181 (9.94%)  39
WEIGHT DECREASED  1  106/2002 (5.29%)  109 8/181 (4.42%)  8
WHITE BLOOD CELL COUNT DECREASED  1  11/2002 (0.55%)  13 20/181 (11.05%)  85
Metabolism and nutrition disorders     
DECREASED APPETITE  1  320/2002 (15.98%)  398 16/181 (8.84%)  23
HYPOALBUMINAEMIA  1  13/2002 (0.65%)  13 11/181 (6.08%)  14
HYPOKALAEMIA  1  73/2002 (3.65%)  91 19/181 (10.50%)  37
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  265/2002 (13.24%)  349 6/181 (3.31%)  7
BACK PAIN  1  199/2002 (9.94%)  226 5/181 (2.76%)  5
MUSCLE SPASMS  1  124/2002 (6.19%)  154 1/181 (0.55%)  1
MUSCULOSKELETAL PAIN  1  135/2002 (6.74%)  150 3/181 (1.66%)  3
MYALGIA  1  205/2002 (10.24%)  279 8/181 (4.42%)  11
PAIN IN EXTREMITY  1  148/2002 (7.39%)  169 3/181 (1.66%)  3
Nervous system disorders     
DIZZINESS  1  117/2002 (5.84%)  137 11/181 (6.08%)  17
HEADACHE  1  454/2002 (22.68%)  650 19/181 (10.50%)  32
PARAESTHESIA  1  128/2002 (6.39%)  139 4/181 (2.21%)  5
PERIPHERAL SENSORY NEUROPATHY  1  113/2002 (5.64%)  132 0/181 (0.00%)  0
Psychiatric disorders     
INSOMNIA  1  118/2002 (5.89%)  134 11/181 (6.08%)  13
Respiratory, thoracic and mediastinal disorders     
COUGH  1  220/2002 (10.99%)  256 23/181 (12.71%)  28
DYSPNOEA  1  211/2002 (10.54%)  705 2/181 (1.10%)  6
EPISTAXIS  1  402/2002 (20.08%)  669 30/181 (16.57%)  43
Vascular disorders     
HYPERTENSION  1  96/2002 (4.80%)  113 12/181 (6.63%)  17
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01702571    
Other Study ID Numbers: MO28231
2012-001628-37 ( EudraCT Number )
First Submitted: October 4, 2012
First Posted: October 8, 2012
Results First Submitted: July 14, 2021
Results First Posted: August 5, 2021
Last Update Posted: August 5, 2021