SYD985 vs. Physician's Choice in Participants With HER2-p... | NCT03262935

Label	Type	Description	Intervention Names
(vic-)trastuzumab duocarmazine	Experimental	SYD985, every 3 weeks (Q3W)	Drug: (vic-)trastuzumab duocarmazine
Physician's choice	Active Comparator	Lap/Cap T/Cap T/Vino T/Eri	Drug: Physician's choice

Name	Type	Description	Arm Group Labels	Other Names
(vic-)trastuzumab duocarmazine	Drug	Intravenous SYD985, Q3W	(vic-)trastuzumab duocarmazine

Measure	Description	Time Frame
Progression Free Survival	Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier.	baseline until primary analysis data cut-off date of 31March2021

Measure	Description	Time Frame
Overall Survival	Overall survival is defined as the time from date of randomization to death due to any cause.	baseline until final Overall Survival analysis data cut-off date of 30June2022
Objective Response Rate

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Female patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer;
Patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment for locally advanced or metastatic disease;
HER2-positive tumor status;
Patients must have measurable or non-measurable disease that is evaluable per RECIST 1.1;
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Estimated life expectancy > 12 weeks at randomization;
Adequate organ function and blood cell counts.

Main Exclusion Criteria:

Current or previous use of a prohibited medication as listed in the protocol;
History of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine;
History of keratitis;
Severe, uncontrolled systemic disease at screening;
Left Ventricular Ejection Fraction (LVEF) < 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;
Cardiac troponin value above the Upper Limit of Normal (ULN);
History of clinically significant cardiovascular disease;
Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.

Name	Affiliation	Role
Evelyn van den Tweel, PhD	Byondis B.V., The Netherlands	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southern Cancer Center		Mobile	Alabama	36608	United States
Arizona Clinical Research Center

PubMed Identifier	Type	Citation	Retractions
39442070	Derived	Turner N, Saura C, Aftimos P, van den Tweel E, Oesterholt M, Koper N, Colleoni M, Kaczmarek E, Punie K, Song X, Armstrong A, Bianchi G, Stradella A, Ladoire S, Lim JSJ, Quenel-Tueux N, Tan TJ, Escriva-de-Romani S, O'Shaughnessy J; TULIP Trial Investigators. Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP). J Clin Oncol. 2025 Feb 10;43(5):513-523. doi: 10.1200/JCO.24.00529. Epub 2024 Oct 23.

ID	Title	Description
FG000	(Vic-)Trastuzumab Duocarmazine	SYD985, every 3 weeks (Q3W) (vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W
FG001	Physician's Choice	Lap/Cap T/Cap T/Vino T/Eri Physician's choice: See drug label

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 18, 2021	Jun 30, 2023

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

Progression Free Survival

Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier.

Full-analysis set (FAS) was used for this primary endpoint analysis. FAS comprises all randomized patients, which were analyzed according to the treatment group and strata they have been assigned to during the randomization procedure.

Posted

Median

95% Confidence Interval

months

baseline until primary analysis data cut-off date of 31March2021

ID	Title	Description
OG000	(Vic-)Trastuzumab Duocarmazine	SYD985, every 3 weeks (Q3W) (vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W
OG001	Physician's Choice	Lap/Cap T/Cap T/Vino T/Eri Physician's choice: See drug label

Units	Counts
Participants	OG000291 OG001146

Title

Denominators

Categories

Title	Measurements
	OG0007.0(5.4 to 7.2) OG0014.9(4.0 to 5.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A stratified Cox regression analysis was used to estimate the hazard ratio of PFS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, >2), and prior treatment with pertuzumab (yes, no).	Log Rank		=0.002	P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.	Hazard Ratio (HR)	0.6401			2-Sided	95	0.4885	0.8389					Superiority

Secondary

Overall Survival

Overall survival is defined as the time from date of randomization to death due to any cause.

Full-analysis set (FAS) was used for the overall survival analysis. FAS comprises all randomized patients, which were analyzed according to the treatment group and strata they have been assigned to during the randomization procedure.

Posted

Median

95% Confidence Interval

months

baseline until final Overall Survival analysis data cut-off date of 30June2022

ID	Title	Description
OG000	(Vic-)Trastuzumab Duocarmazine	SYD985, every 3 weeks (Q3W) (vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W
OG001	Physician's Choice	Lap/Cap T/Cap T/Vino T/Eri Physician's choice: See drug label

Units	Counts
Participants	OG000

Secondary

Objective Response Rate

Objective Response Rate is defined as the proportion of patients with a centrally assessed best overall response of complete response or partial response according to RECIST v1.1.

Posted

Number

95% Confidence Interval

percentage of patients

baseline until primary analysis data cut-off date of 31March2021

ID	Title	Description
OG000	(Vic-)Trastuzumab Duocarmazine	SYD985, every 3 weeks (Q3W) (vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W
OG001	Physician's Choice	Lap/Cap T/Cap T/Vino T/Eri Physician's choice: See drug label

Units	Counts
Participants

Secondary

Investigator Assessed Progression Free Survival

Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier.

Posted

Median

95% Confidence Interval

months

baseline until primary analysis data cut-off date of 31March2021

ID	Title	Description
OG000	(Vic-)Trastuzumab Duocarmazine	SYD985, every 3 weeks (Q3W) (vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W
OG001	Physician's Choice	Lap/Cap T/Cap T/Vino T/Eri Physician's choice: See drug label

Units	Counts
Participants	OG000

Secondary

Patient Reported Outcomes for Health Related Quality of Life

Change in the global health status/Quality of Life (QoL) scale score of the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire C30 from baseline (cycle 1). The raw score (1 to 7) has been transformed to a score ranging from 0 to 100. A higher score means a better outcome: hence a positive change from baseline means an improvement in global health status/Quality of Life and a negative change from baseline means a worsening of global health status/Quality of Life.

Posted

Least Squares Mean

95% Confidence Interval

scores on a scale

baseline until primary analysis data cut-off date of 31March2021

ID	Title	Description
OG000	(Vic-)Trastuzumab Duocarmazine	SYD985, every 3 weeks (Q3W) (vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W
OG001	Physician's Choice	Lap/Cap T/Cap T/Vino T/Eri Physician's choice: See drug label

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Haemorrhagic tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected137 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Catheter site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Drug intolerance	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected137 at risk
General physical health deterioration	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected137 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0008 events7 affected288 at risk EG0010 events0 affected137 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected137 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected137 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected137 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0013 events3 affected137 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected137 at risk
Anxiety	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Device occlusion	Product Issues	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Platelet count decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected288 at risk EG0010 events0 affected137 at risk
Ejection fraction decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Staphylococcus test positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected288 at risk EG0010 events0 affected137 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0005 events2 affected288 at risk EG0010 events0 affected137 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected137 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected137 at risk
Keratitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected288 at risk EG0010 events0 affected137 at risk
Conjunctivitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Eyelid ptosis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected137 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected137 at risk
Ascites	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected137 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0011 events1 affected137 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected137 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected137 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected137 at risk
Livedo reticularis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected137 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 events3 affected288 at risk EG0011 events1 affected137 at risk
Wound infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected137 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected288 at risk EG0010 events0 affected137 at risk
Device related infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Endocarditis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Erysipelas	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0012 events1 affected137 at risk
Viral infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected288 at risk EG0011 events1 affected137 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected288 at risk EG0010 events0 affected137 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected288 at risk EG0010 events0 affected137 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Weight decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG00045 events29 affected288 at risk EG0012 events2 affected137 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00026 events16 affected288 at risk EG00114 events10 affected137 at risk
Platelet count decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG00028 events16 affected288 at risk EG0010 events0 affected137 at risk
Neutrophil count decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG00025 events14 affected288 at risk EG00126 events14 affected137 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG00019 events12 affected288 at risk EG00117 events10 affected137 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00037 events33 affected288 at risk EG00123 events16 affected137 at risk
Dysgeusia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00026 events22 affected288 at risk EG0015 events4 affected137 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00022 events21 affected288 at risk EG0017 events7 affected137 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG00029 events16 affected288 at risk EG00116 events8 affected137 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0007 events5 affected288 at risk EG00111 events7 affected137 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG000162 events96 affected288 at risk EG00166 events41 affected137 at risk
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG00091 events58 affected288 at risk EG00134 events23 affected137 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG00026 events23 affected288 at risk EG00115 events13 affected137 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG00030 events22 affected288 at risk EG0014 events3 affected137 at risk
Mucosal inflammation	General disorders	MedDRA 23.1	Systematic Assessment	EG00020 events17 affected288 at risk EG00110 events8 affected137 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG00085 events41 affected288 at risk EG00135 events17 affected137 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG00075 events31 affected288 at risk EG00176 events33 affected137 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG00023 events17 affected288 at risk EG00113 events7 affected137 at risk
Conjunctivitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG000218 events110 affected288 at risk EG0013 events3 affected137 at risk
Keratitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG000202 events110 affected288 at risk EG00111 events11 affected137 at risk
Dry eye	Eye disorders	MedDRA 23.1	Systematic Assessment	EG000117 events87 affected288 at risk EG00115 events14 affected137 at risk
Lacrimation increased	Eye disorders	MedDRA 23.1	Systematic Assessment	EG00074 events53 affected288 at risk EG0012 events2 affected137 at risk
Blepharitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG00053 events36 affected288 at risk EG0012 events2 affected137 at risk
Punctate keratitis	Eye disorders	MedDRA 23.1	Systematic Assessment	EG00045 events32 affected288 at risk EG0014 events3 affected137 at risk
Vision blurred	Eye disorders	MedDRA 23.1	Systematic Assessment	EG00030 events23 affected288 at risk EG0011 events1 affected137 at risk
Periorbital oedema	Eye disorders	MedDRA 23.1	Systematic Assessment	EG00029 events17 affected288 at risk EG0010 events0 affected137 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG000103 events73 affected288 at risk EG00164 events43 affected137 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00082 events60 affected288 at risk EG00192 events49 affected137 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00074 events52 affected288 at risk EG00128 events24 affected137 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00052 events36 affected288 at risk EG00137 events23 affected137 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00028 events26 affected288 at risk EG0016 events6 affected137 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00034 events24 affected288 at risk EG00117 events17 affected137 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00030 events19 affected288 at risk EG00117 events11 affected137 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00020 events18 affected288 at risk EG00112 events9 affected137 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG00015 events13 affected288 at risk EG00111 events9 affected137 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00060 events48 affected288 at risk EG00117 events14 affected137 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00052 events42 affected288 at risk EG00127 events17 affected137 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00023 events19 affected288 at risk EG0010 events0 affected137 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00017 events14 affected288 at risk EG0019 events8 affected137 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00074 events62 affected288 at risk EG00121 events16 affected137 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00036 events32 affected288 at risk EG0011 events1 affected137 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00027 events27 affected288 at risk EG0018 events8 affected137 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00018 events17 affected288 at risk EG0016 events5 affected137 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG00016 events15 affected288 at risk EG0012 events2 affected137 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected288 at risk EG00170 events32 affected137 at risk
Insomnia	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG00024 events23 affected288 at risk EG0016 events6 affected137 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00036 events31 affected288 at risk EG00114 events11 affected137 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00023 events22 affected288 at risk EG00114 events11 affected137 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00020 events18 affected288 at risk EG00119 events12 affected137 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG00014 events11 affected288 at risk EG0017 events7 affected137 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00028 events25 affected288 at risk EG00114 events14 affected137 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG00012 events9 affected288 at risk EG00111 events8 affected137 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00075 events61 affected288 at risk EG00120 events15 affected137 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG00013 events11 affected288 at risk EG00112 events9 affected137 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0007 events7 affected288 at risk EG00110 events7 affected137 at risk

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

ID	Term
C000656468	trastuzumab duocarmazine
D000077341	Lapatinib
D022782	CCAAT-Enhancer-Binding Protein-beta
D000069287	Capecitabine
D002214	Capsules
D000068878	Trastuzumab
D000077235	Vinorelbine
C490954	eribulin

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D022762	CCAAT-Enhancer-Binding Proteins
D050976	Basic-Leucine Zipper Transcription Factors
D004268	DNA-Binding Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D009687	Nuclear Proteins
D014157	Transcription Factors
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D012712	Serum Globulins
D005916	Globulins
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D007211	Indoles
D054836	Indolizidines
D007212	Indolizines

ID	Title	Description
BG000	(Vic-)Trastuzumab Duocarmazine	SYD985, every 3 weeks (Q3W) (vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W
BG001	Physician's Choice	Lap/Cap T/Cap T/Vino T/Eri Physician's choice: See drug label
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	(Vic-)Trastuzumab Duocarmazine	SYD985, every 3 weeks (Q3W) (vic-)trastuzumab duocarmazine: Intravenous SYD985, Q3W	181	288	53	288	278	288
EG001	Physician's Choice	Lap/Cap T/Cap T/Vino T/Eri Physician's choice: See drug label	94	137	12	137	132	137