Evaluation of Carboplatin/Paclitaxel With and Without Tra... | NCT01367002

Name	Class
Genentech, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Carboplatin/Paclitaxel	Active Comparator	Chemotherapy	Drug: Carboplatin/Paclitaxel
Trastuzumab	Experimental	Monoclonal antibody	Drug: Trastuzumab

Name	Type	Description	Arm Group Labels	Other Names
Carboplatin/Paclitaxel	Drug	Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.

Measure	Description	Time Frame
Progression Free Survival Differences Between Treatment Arms.	Progression free survival differences between treatment arms.	6 years

Measure	Description	Time Frame
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0	To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0. Presented are counts of those that experience any Serious Adverse Events or All Other Adverse Events.	6 years
To Assess Objective Response Rate (ORR)

Name	Affiliation	Role
Alessandro D Santin, M.D.	Yale University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Hospital and Medical Center		Phoenix	Arizona	85013	United States
University of Arizona Cancer Center

PubMed Identifier	Type	Citation	Retractions
12006548	Background	Santin AD, Bellone S, Gokden M, Palmieri M, Dunn D, Agha J, Roman JJ, Hutchins L, Pecorelli S, O'Brien T, Cannon MJ, Parham GP. Overexpression of HER-2/neu in uterine serous papillary cancer. Clin Cancer Res. 2002 May;8(5):1271-9.
15746676	Background	Santin AD, Bellone S, Siegel ER, Palmieri M, Thomas M, Cannon MJ, Kay HH, Roman JJ, Burnett A, Pecorelli S. Racial differences in the overexpression of epidermal growth factor type II receptor (HER2/neu): a major prognostic indicator in uterine serous papillary cancer. Am J Obstet Gynecol. 2005 Mar;192(3):813-8. doi: 10.1016/j.ajog.2004.10.605.

ID	Title	Description
FG000	Carboplatin/Paclitaxel	Chemotherapy Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
FG001	Trastuzumab

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 6, 2020

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 Differences Between Treatment Arms.

Progression free survival differences between treatment arms.

Only patients eligible to be assessed for progression free survival.

Posted

Median

95% Confidence Interval

months

6 years

ID	Title	Description
OG000	Carboplatin/Paclitaxel	Chemotherapy Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
OG001	Trastuzumab	Monoclonal antibody Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.

Units	Counts
Participants	OG00028 OG00130

Title

Denominators

Categories

Title	Measurements
	OG0008.049(7.129 to 9.692) OG00112.945(10.448 to 18.103)

Secondary

To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0

To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0. Presented are counts of those that experience any Serious Adverse Events or All Other Adverse Events.

Posted

Count of Participants

Participants

6 years

ID	Title	Description
OG000	Carboplatin/Paclitaxel	Chemotherapy Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
OG001	Trastuzumab	Monoclonal antibody Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.

Secondary

To Assess Objective Response Rate (ORR)

To assess objective response rate (ORR)

Among those with recurrent disease- see baseline characteristics table.

Posted

Count of Participants

Participants

6 years

ID	Title	Description
OG000	Carboplatin/Paclitaxel	Chemotherapy Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
OG001	Trastuzumab	Monoclonal antibody Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.

Units

Secondary

To Assess Overall Survival (OS)

To assess overall survival (OS), presented are the number of participants that survived through the duration of the study period.

Posted

Count of Participants

Participants

6 years

ID	Title	Description
OG000	Carboplatin/Paclitaxel	Chemotherapy Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
OG001	Trastuzumab	Monoclonal antibody Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.

Units	Counts

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG00033 events13 affected28 at risk EG00160 events16 affected32 at risk
Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events2 affected28 at risk EG00128 events8 affected32 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events1 affected32 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Allergic reaction	Immune system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Eye infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Infections and infestations - Other	Infections and infestations	Systematic Assessment	EG0003 events2 affected28 at risk EG0012 events2 affected32 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0016 events4 affected32 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected28 at risk EG0015 events3 affected32 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0005 events4 affected28 at risk EG00112 events6 affected32 at risk
Vaginal infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Abdominal infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Esophageal infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Nail infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Mucosal infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Peripheral nerve infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Bruising	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events1 affected28 at risk EG0012 events2 affected32 at risk
Burn	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0014 events1 affected32 at risk
Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Injury, poisoning and procedural complications - Other	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Dermatitis radiation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0001 events1 affected28 at risk EG0017 events4 affected32 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG0007 events4 affected28 at risk EG0010 events0 affected32 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0015 events3 affected32 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG0002 events2 affected28 at risk EG0012 events1 affected32 at risk
Cholesterol high	Investigations	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Creatinine increased	Investigations	Systematic Assessment	EG0007 events4 affected28 at risk EG00121 events9 affected32 at risk
Investigations - Other	Investigations	Systematic Assessment	EG0003 events2 affected28 at risk EG0013 events2 affected32 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0004 events3 affected28 at risk EG0019 events2 affected32 at risk
Lymphocyte count increased	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG00038 events9 affected28 at risk EG00128 events11 affected32 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0008 events6 affected28 at risk EG00110 events7 affected32 at risk
Weight gain	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0019 events3 affected32 at risk
Weight loss	Investigations	Systematic Assessment	EG0001 events1 affected28 at risk EG0013 events2 affected32 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG00036 events7 affected28 at risk EG00145 events6 affected32 at risk
Ejection fraction decreased	Investigations	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG0006 events4 affected28 at risk EG00116 events10 affected32 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events1 affected32 at risk
Hypercalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events2 affected32 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0006 events1 affected28 at risk EG00129 events8 affected32 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Hypermagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Hypernatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events2 affected32 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0011 events1 affected32 at risk
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0015 events2 affected32 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events1 affected32 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0008 events6 affected28 at risk EG0016 events4 affected32 at risk
Hypomagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0009 events8 affected28 at risk EG00121 events5 affected32 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected28 at risk EG0012 events2 affected32 at risk
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0011 events1 affected32 at risk
Metabolism and nutrition disorders - Other	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0016 events2 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 events4 affected28 at risk EG00111 events5 affected32 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0015 events1 affected32 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events2 affected28 at risk EG00112 events10 affected32 at risk
Bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0017 events4 affected32 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Musculoskeletal and connective tissue disorder - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events1 affected28 at risk EG00112 events5 affected32 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00012 events6 affected28 at risk EG00116 events10 affected32 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0006 events4 affected28 at risk EG00114 events8 affected32 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Musculoskeletal deformity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected28 at risk EG0013 events1 affected32 at risk
Cognitive disturbance	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0005 events3 affected28 at risk EG0013 events2 affected32 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0003 events3 affected28 at risk EG0011 events1 affected32 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0019 events6 affected32 at risk
Movements involuntary	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Nervous system disorders - Other	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0014 events2 affected32 at risk
Neuralgia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Paresthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Peripheral motor neuropathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0015 events4 affected32 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG00022 events15 affected28 at risk EG00124 events17 affected32 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Tremor	Nervous system disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events1 affected32 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0005 events4 affected28 at risk EG0014 events4 affected32 at risk
Confusion	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0014 events4 affected32 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0006 events5 affected28 at risk EG00111 events10 affected32 at risk
Psychiatric disorders - Other	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Restlessness	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Cardiac disorders - Other	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0015 events5 affected32 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Ventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Left ventricular systolic dysfunction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected28 at risk EG0012 events2 affected32 at risk
Renal and urinary disorders - Other	Renal and urinary disorders	Systematic Assessment	EG0006 events6 affected28 at risk EG0011 events1 affected32 at risk
Urinary frequency	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected28 at risk EG0011 events1 affected32 at risk
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0018 events5 affected32 at risk
Urinary urgency	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0014 events2 affected32 at risk
Urine discoloration	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Bladder spasm	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Urinary tract pain	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Chronic kidney disease	Renal and urinary disorders	Systematic Assessment	EG0007 events1 affected28 at risk EG0010 events0 affected32 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Pelvic pain	Reproductive system and breast disorders	Systematic Assessment	EG0005 events2 affected28 at risk EG0012 events2 affected32 at risk
Reproductive system and breast disorders - Other	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Vaginal discharge	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events2 affected32 at risk
Vaginal dryness	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Vaginal hemorrhage	Reproductive system and breast disorders	Systematic Assessment	EG0003 events2 affected28 at risk EG0012 events1 affected32 at risk
Vaginal inflammation	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events1 affected32 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events5 affected28 at risk EG00117 events10 affected32 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0009 events6 affected28 at risk EG00120 events10 affected32 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events1 affected28 at risk EG0012 events1 affected32 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0015 events3 affected32 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events2 affected28 at risk EG0010 events0 affected32 at risk
Postnasal drip	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0014 events2 affected32 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0014 events2 affected32 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0014 events4 affected32 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00027 events14 affected28 at risk EG00130 events15 affected32 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events2 affected32 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events1 affected32 at risk
Nail discoloration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Pain of skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Photosensitivity	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0014 events2 affected32 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0006 events4 affected28 at risk EG0017 events4 affected32 at risk
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0006 events5 affected28 at risk EG0019 events7 affected32 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Skin ulceration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Scalp pain	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Nail ridging	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Flushing	Vascular disorders	Systematic Assessment	EG0002 events1 affected28 at risk EG0011 events1 affected32 at risk
Hot flashes	Vascular disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0011 events1 affected32 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0006 events5 affected28 at risk EG00122 events11 affected32 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0012 events2 affected32 at risk
Thromboembolic event	Vascular disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events2 affected32 at risk
Vascular disorders - Other	Vascular disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Ear and labyrinth disorders - Other	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0013 events2 affected32 at risk
Tinnitus	Vascular disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events2 affected32 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Endocrine disorders - Other	Endocrine disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Hypothyroidism	Vascular disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0011 events1 affected32 at risk
Blurred vision	Eye disorders	Systematic Assessment	EG0003 events2 affected28 at risk EG0012 events2 affected32 at risk
Conjunctivitis	Eye disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Dry eye	Eye disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Eye disorders - Other	Eye disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events1 affected32 at risk
Floaters	Eye disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Glaucoma	Eye disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Retinopathy	Eye disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events2 affected32 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected28 at risk EG00122 events16 affected32 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Bloating	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00016 events9 affected28 at risk EG00126 events17 affected32 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00012 events5 affected28 at risk EG00130 events13 affected32 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0014 events3 affected32 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Esophagitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Fecal incontinence	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Gastric ulcer	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Gastrointestinal disorders - Other	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected28 at risk EG0019 events6 affected32 at risk
Gastrointestinal pain	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected32 at risk
Hemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Mucositis oral	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0013 events2 affected32 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00016 events11 affected28 at risk EG00152 events18 affected32 at risk
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Rectal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0011 events1 affected32 at risk
Stomach pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0005 events4 affected28 at risk EG00117 events10 affected32 at risk
Anal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 events1 affected28 at risk EG0010 events0 affected32 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0017 events5 affected32 at risk
Chills	General disorders	Systematic Assessment	EG0001 events1 affected28 at risk EG0012 events1 affected32 at risk
Fatigue	General disorders	Systematic Assessment	EG00034 events17 affected28 at risk EG00162 events23 affected32 at risk
Fever	General disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0015 events3 affected32 at risk
Flu like symptoms	General disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected32 at risk
General disorders and administration site conditions - Other	General disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG0016 events4 affected32 at risk
Pain	General disorders	Systematic Assessment	EG0002 events2 affected28 at risk EG00119 events10 affected32 at risk
Edema limbs	General disorders	Systematic Assessment	EG0005 events4 affected28 at risk EG00111 events7 affected32 at risk
Infusion related reaction	General disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0012 events2 affected32 at risk
Localized edema	General disorders	Systematic Assessment	EG0000 events0 affected28 at risk EG0013 events2 affected32 at risk

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

ID	Term
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	Carboplatin/Paclitaxel	Chemotherapy Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
BG001	Trastuzumab	Monoclonal antibody Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
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	Carboplatin/Paclitaxel	Chemotherapy Carboplatin/Paclitaxel: Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.	21	28	6	28	28	28
EG001	Trastuzumab	Monoclonal antibody Trastuzumab: Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.	21	32	14	32	32	32