A Study of Trastuzumab Emtansine in Participants With Hum... | NCT01702571

ID	Type	Description	Link
2012-001628-37	EudraCT Number

Label	Type	Description	Intervention Names
Trastuzumab Emtansine (All Participants)	Experimental	This cohort will enroll all participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.	Drug: Trastuzumab Emtansine
Trastuzumab Emtansine (Asian Participants)	Experimental	This cohort will enroll Asian race participants with HER2-positive, unresectable, LABC or mBC who have received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants will receive trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.	Drug: Trastuzumab Emtansine

Name	Type	Description	Arm Group Labels	Other Names
Trastuzumab Emtansine	Drug	Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.

Measure	Description	Time Frame
Percentage of Participants With Adverse Events of Primary Interest (AEPIs)	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.	Baseline up to approximately 7 years

Measure	Description	Time Frame
Percentage of Participants With Specific AEPIs	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.	Baseline up to approximately 7 years

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CEMIC		Buenos Aires		C1431FWO	Argentina
Centro Oncologico Riojano Integral (CORI)

PubMed Identifier	Type	Citation	Retractions
36084395	Derived	Wuerstlein R, Ellis P, Montemurro F, Anton Torres A, Delaloge S, Zhang Q, Wang X, Wang S, Shao Z, Li H, Rachman A, Vongsaisuwon M, Liu H, Fear S, Pena-Murillo C, Barrios C. Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer. ESMO Open. 2022 Oct;7(5):100561. doi: 10.1016/j.esmoop.2022.100561. Epub 2022 Sep 7.
34741021

ID	Title	Description
FG000	Trastuzumab Emtansine (All Participants)	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 18, 2019	Jul 14, 2021

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 Adverse Events of Primary Interest (AEPIs)

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.

The safety population included all participants who had received at least 1 dose of study medication.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline up to approximately 7 years

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001	Trastuzumab Emtansine (Asian Participants)	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.

Units	Counts
Participants	OG0002002 OG001181

Title

Denominators

Categories

Title	Measurements
	OG00023.1(21.2 to 25.0) OG00151.4(43.9 to 58.9)

Secondary

Percentage of Participants With Specific AEPIs

The safety population included all participants who had received at least 1 dose of study medication.

Posted

Number

Percentage of Participants

Baseline up to approximately 7 years

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001	Trastuzumab Emtansine (Asian Participants)	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.

Secondary

Percentage of Participants With Adverse Events of Special Interest (AESIs)

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.

The safety population included all participants who had received at least 1 dose of study medication.

Posted

Number

Percentage of Participants

Baseline up to approximately 7 years

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.

Secondary

Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment

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).

Intent to Treat (ITT) Population included all participants enrolled in the study.

Posted

Median

95% Confidence Interval

months

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)

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001	Trastuzumab Emtansine (Asian Participants)

Secondary

Overall Survival

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.

ITT Population included all participants enrolled in the study.

Posted

Median

95% Confidence Interval

months

Baseline until death (up to approximately 7 years)

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001	Trastuzumab Emtansine (Asian Participants)	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.

Secondary

Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment

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.

ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.

Secondary

Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1

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.

ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001	Trastuzumab Emtansine (Asian Participants)	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.

Secondary

Duration of Response (DOR) According to RECIST v 1.1

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).

ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001

Secondary

Time to Response According to RECIST v 1.1

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.

ITT Population included all participants enrolled in the study. Only responders were included in the analysis.

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001	Trastuzumab Emtansine (Asian Participants)	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.

Secondary

Number of Hospital Visits

The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.

The safety population included all participants who had received at least 1 dose of study medication.

Posted

Mean

Standard Deviation

Number of Hospital Visits

Baseline up to approximately 7 years

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001	Trastuzumab Emtansine (Asian Participants)	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.

Secondary

Type of Hospital Visits

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.

The safety population included all participants who had received at least 1 dose of study medication.

Posted

Number

Participants

Baseline up to approximately 7 years

ID	Title	Description
OG000	Trastuzumab Emtansine (All Participants)	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.
OG001	Trastuzumab Emtansine (Asian Participants)	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG00014 events13 affected2,002 at risk EG0010 events0 affected181 at risk
BONE MARROW FAILURE	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG00011 events11 affected2,002 at risk EG00111 events10 affected181 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0011 events1 affected181 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PALPITATIONS	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0011 events1 affected181 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BLINDNESS	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CATARACT	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected2,002 at risk EG0011 events1 affected181 at risk
RETINAL VEIN THROMBOSIS	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00012 events4 affected2,002 at risk EG0011 events1 affected181 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
ANAL FISSURE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ANAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events2 affected2,002 at risk EG0010 events0 affected181 at risk
ASCITES	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 events2 affected2,002 at risk EG0010 events0 affected181 at risk
COLITIS	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected2,002 at risk EG0010 events0 affected181 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected2,002 at risk EG0010 events0 affected181 at risk
GASTRIC ANTRAL VASCULAR ECTASIA	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00010 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GASTRODUODENAL ULCER	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00010 events3 affected2,002 at risk EG0010 events0 affected181 at risk
GINGIVAL BLEEDING	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GLOSSITIS	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected2,002 at risk EG0010 events0 affected181 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0012 events1 affected181 at risk
MELAENA	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0008 events2 affected2,002 at risk EG0010 events0 affected181 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 events5 affected2,002 at risk EG0011 events1 affected181 at risk
OESOPHAGEAL FISTULA	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
OESOPHAGEAL VARICES HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PERIODONTAL DISEASE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PROCTALGIA	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SMALL INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events2 affected2,002 at risk EG0010 events0 affected181 at risk
TOOTH LOSS	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 events3 affected2,002 at risk EG0016 events2 affected181 at risk
VOMITING	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00019 events17 affected2,002 at risk EG0011 events1 affected181 at risk
ASTHENIA	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
CATHETER SITE ERYTHEMA	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CHILLS	General disorders	MedDRA 19.1	Systematic Assessment	EG0006 events2 affected2,002 at risk EG0010 events0 affected181 at risk
DEATH	General disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected2,002 at risk EG0010 events0 affected181 at risk
FATIGUE	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected2,002 at risk EG0010 events0 affected181 at risk
HYPERTHERMIA	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
IMPLANT SITE DEHISCENCE	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
INFLAMMATION	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
MALAISE	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0011 events1 affected181 at risk
PYREXIA	General disorders	MedDRA 19.1	Systematic Assessment	EG00042 events13 affected2,002 at risk EG0010 events0 affected181 at risk
SUDDEN DEATH	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected2,002 at risk EG0011 events1 affected181 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
CHOLESTASIS	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
DRUG-INDUCED LIVER INJURY	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0003 events1 affected2,002 at risk EG0013 events1 affected181 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG00010 events5 affected2,002 at risk EG0010 events0 affected181 at risk
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HEPATIC PAIN	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HEPATOTOXICITY	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG00014 events7 affected2,002 at risk EG0010 events0 affected181 at risk
JAUNDICE	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
NODULAR REGENERATIVE HYPERPLASIA	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0006 events3 affected2,002 at risk EG0010 events0 affected181 at risk
NON-CIRRHOTIC PORTAL HYPERTENSION	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PORTAL HYPERTENSION	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0004 events2 affected2,002 at risk EG0010 events0 affected181 at risk
ALLERGIC OEDEMA	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0003 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0006 events2 affected2,002 at risk EG0010 events0 affected181 at risk
ABSCESS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ACINETOBACTER INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BACTERAEMIA	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BRAIN ABSCESS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BREAST CELLULITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
BRONCHITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected2,002 at risk EG0010 events0 affected181 at risk
CATHETER SITE INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CELLULITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00010 events8 affected2,002 at risk EG0010 events0 affected181 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CYSTITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
DENGUE HAEMORRHAGIC FEVER	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected2,002 at risk EG0011 events1 affected181 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected2,002 at risk EG0010 events0 affected181 at risk
ENCEPHALITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
ERYSIPELAS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0005 events4 affected2,002 at risk EG0010 events0 affected181 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
GASTROENTERITIS NOROVIRUS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GASTROINTESTINAL VIRAL INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
INFECTIVE EXACERBATION OF BRONCHIECTASIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
KLEBSIELLA BACTERAEMIA	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
LISTERIOSIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
LIVER ABSCESS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00010 events9 affected2,002 at risk EG0010 events0 affected181 at risk
MASTITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
MENINGITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
OTITIS MEDIA	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
PERITONITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
PHARYNGITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0011 events1 affected181 at risk
PNEUMOCOCCAL INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PNEUMONIA	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00023 events22 affected2,002 at risk EG0018 events8 affected181 at risk
PNEUMONIA STREPTOCOCCAL	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PYELONEPHRITIS CHRONIC	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SEPSIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0009 events9 affected2,002 at risk EG0010 events0 affected181 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SKIN INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SOFT TISSUE INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
STREPTOCOCCAL INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
TRACHEOBRONCHITIS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected2,002 at risk EG0010 events0 affected181 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00012 events11 affected2,002 at risk EG0010 events0 affected181 at risk
VASCULAR DEVICE INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
VULVAL ABSCESS	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ANASTOMOTIC ULCER	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected2,002 at risk EG0010 events0 affected181 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0008 events8 affected2,002 at risk EG0010 events0 affected181 at risk
FOREARM FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0006 events2 affected2,002 at risk EG0010 events0 affected181 at risk
INTENTIONAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
RADIATION NECROSIS	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SKELETAL INJURY	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SPLENIC INJURY	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
AMYLASE INCREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected2,002 at risk EG0010 events0 affected181 at risk
BLOOD BILIRUBIN INCREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0011 events1 affected181 at risk
ECG SIGNS OF MYOCARDIAL ISCHAEMIA	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
LIVER FUNCTION TEST INCREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected2,002 at risk EG0011 events1 affected181 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG00112 events8 affected181 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected2,002 at risk EG0011 events1 affected181 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0012 events1 affected181 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BONE LESION	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
HAEMATOMA MUSCLE	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
KYPHOSIS	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
MOBILITY DECREASED	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
OSTEONECROSIS OF JAW	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SPINAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
SYSTEMIC LUPUS ERYTHEMATOSUS	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BENIGN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BREAST CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CANCER PAIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
MENINGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
METASTATIC UTERINE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
NAEVUS HAEMORRHAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SKIN NEOPLASM BLEEDING	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
APHASIA	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0004 events2 affected2,002 at risk EG0010 events0 affected181 at risk
ATAXIA	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BRAIN OEDEMA	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0007 events6 affected2,002 at risk EG0010 events0 affected181 at risk
CENTRAL NERVOUS SYSTEM NECROSIS	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0008 events4 affected2,002 at risk EG0012 events1 affected181 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
DIZZINESS	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected2,002 at risk EG0010 events0 affected181 at risk
EPILEPSY	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG00015 events8 affected2,002 at risk EG0010 events0 affected181 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0006 events3 affected2,002 at risk EG0010 events0 affected181 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HEADACHE	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected2,002 at risk EG0010 events0 affected181 at risk
IIIRD NERVE PARESIS	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
LEUKOENCEPHALOPATHY	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
MIGRAINE	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
MOTOR DYSFUNCTION	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
NERVOUS SYSTEM DISORDER	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PARTIAL SEIZURES	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
SCIATICA	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
SEIZURE	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG00011 events7 affected2,002 at risk EG0010 events0 affected181 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
VOCAL CORD PARALYSIS	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
DEVICE BREAKAGE	Product Issues	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
DEVICE EXTRUSION	Product Issues	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
DEVICE LOOSENING	Product Issues	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
AGITATION	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ANXIETY	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected2,002 at risk EG0010 events0 affected181 at risk
DEPRESSION	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected2,002 at risk EG0010 events0 affected181 at risk
HALLUCINATION	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0004 events2 affected2,002 at risk EG0010 events0 affected181 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected2,002 at risk EG0010 events0 affected181 at risk
RENAL INJURY	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CYSTOCELE	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
METRORRHAGIA	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
UTERINE HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
UTERINE POLYP	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0011 events1 affected181 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ASTHMATIC CRISIS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CHOKING	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG00024 events7 affected2,002 at risk EG0010 events0 affected181 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0008 events7 affected2,002 at risk EG0010 events0 affected181 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events4 affected2,002 at risk EG0010 events0 affected181 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 events3 affected2,002 at risk EG0010 events0 affected181 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0006 events6 affected2,002 at risk EG0010 events0 affected181 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 events5 affected2,002 at risk EG0010 events0 affected181 at risk
PULMONARY ALVEOLAR HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected2,002 at risk EG0010 events0 affected181 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0011 events1 affected181 at risk
RESPIRATORY TRACT HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SPIDER NAEVUS	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 events1 affected2,002 at risk EG0010 events0 affected181 at risk
BREAST CONSERVING SURGERY	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
SCAR EXCISION	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0003 events1 affected2,002 at risk EG0010 events0 affected181 at risk
EMBOLISM	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
HAEMATOMA	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected2,002 at risk EG0010 events0 affected181 at risk
HYPOTENSION	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0003 events1 affected2,002 at risk EG0010 events0 affected181 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
VENA CAVA THROMBOSIS	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected2,002 at risk EG0010 events0 affected181 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D008453	Maytansine
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D047029	Lactams, Macrocyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D000068878	Trastuzumab
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Trastuzumab Emtansine (All Participants)	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.
BG001	Trastuzumab Emtansine (Asian Participants)	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.
BG002	Total	Total of all reporting groups

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 (All Participants)	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.	1,072	2,002	427	2,002	1,734	2,002
EG001	Trastuzumab Emtansine (Asian Participants)	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.	77	181	36	181	170	181