A Study to Evaluate the Efficacy and Safety of Herceptin®... | NCT00022672

NCT00022672

Status Module

Name	Class
Genentech, Inc.	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
trastuzumab + anastrozole	Experimental	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.	Drug: trastuzumab (Herceptin®) Drug: anastrazole (Arimidex®)
anastrozole	Active Comparator	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.	Drug: anastrazole (Arimidex®)

Name	Type	Description	Arm Group Labels	Other Names
trastuzumab (Herceptin®)	Drug	4mg/kg iv loading dose, followed by 2mg/kg iv weekly	trastuzumab + anastrozole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.	24 Months, End of Study (Up to 5 years)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinical Benefit	Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.	24 Months, End of Study (Up to 5 years)
Duration of Response at 24 Months

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
FG001	Anastrozole

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
BG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

24 Months

Title	Measurements
	OG0004.8(3.7 to 7) OG0012.4(2 to 4.6)

End of Study

Title	Measurements
	OG000

Secondary

Percentage of Participants With Clinical Benefit

Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.

Posted

Number

Percentage of participants

24 Months, End of Study (Up to 5 years)

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants	OG000

Secondary

Duration of Response at 24 Months

Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.

Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.

Posted

Median

Full Range

Months

24 Months

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Secondary

Time to Response at 24 Months

Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.

Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.

Posted

Median

Full Range

Months

24 Months

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Secondary

Overall Survival at 24 Months

Overall Survival is defined as the number of days from randomization to death.

Posted

Median

95% Confidence Interval

Months

24 Months

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Two-Year Survival

Full Analysis Population included all randomized participants who received study drug.

Posted

Number

Percentage of participants

24 Months

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Overall Tumor Response at 24 Months

Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.

Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.

Posted

Number

Percentage of participants

24 Months

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Secondary

Percentage of Participants With Best Tumor Response at 24 Months

Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.

Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.

Posted

Number

Percentage of participants

24 Months

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Secondary

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline

Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.

The percentage of participants in the following categories:

Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline.

Participants from the Full Analysis Population (includes all randomized participants who received study drug) with data available for analyses.

Posted

Number

Percentage of participants

Baseline, Final Visit (Up to 24 Months)

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Secondary

Duration of Response at End of Study

Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.

Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.

Posted

Median

Full Range

Months

End of Study (Up to 5 years)

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Secondary

Time to Response at End of Study

Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.

Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.

Posted

Median

Full Range

Months

End of Study (Up to 5 years)

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Secondary

Percentage of Participants With Overall Tumor Response at End of Study

Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.

Posted

Number

Percentage of participants

End of Study (Up to 5 years)

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Secondary

Percentage of Participants With Best Tumor Response at End of Study

Full Analysis Population includes all randomized participants who received study drug.

Posted

Number

Percentage of participants

End of Study (Up to 5 years)

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events

Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.

Safety population included all participants who received at least one dose of study drug.

Posted

Number

Participants

Throughout the Study (Up to 5 years)

ID	Title	Description
OG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
OG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Trastuzumab + Anastrozole	Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.	25	103	89	103
EG001	Anastrozole	1 mg oral dose of anastrozole every day for 24 Months in the Main phase.	6	104	68	104
EG002	Anastrozole (After Start of Trastuzumab)	1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.	8	58	40	58

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0003 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Nausea	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0002 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Constipation	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Gastritis	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Catheter related infection	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Folliculitis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Malaria	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Respiratory tract infection	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Streptococcal sepsis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Chest pain	General disorders	MedDRA (7.1)	Systematic Assessment	EG0003 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Pain	General disorders	MedDRA (7.1)	Systematic Assessment	EG0002 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Pyrexia	General disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Asthenia	General disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (7.1)	Systematic Assessment	EG0002 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Myocardial infarction	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0021 affected58 at risk
Hypertension	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0021 affected58 at risk
Hypotension	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Venous insufficiency	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Urinary retention	Renal and urinary disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0011 affected104 at risk EG0021 affected58 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Headache	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Depression	Psychiatric disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0020 affected58 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0010 affected104 at risk EG0021 affected58 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0010 affected104 at risk EG0021 affected58 at risk
Sudden death	General disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0010 affected104 at risk EG0021 affected58 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0010 affected104 at risk EG0021 affected58 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0010 affected104 at risk EG0021 affected58 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG00011 affected103 at risk EG0015 affected104 at risk EG0023 affected58 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG00020 affected103 at risk EG0018 affected104 at risk EG0028 affected58 at risk
Nausea	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG00015 affected103 at risk EG0015 affected104 at risk EG0025 affected58 at risk
Vomiting	Gastrointestinal disorders	MedDRA (7.1)	Systematic Assessment	EG00021 affected103 at risk EG0015 affected104 at risk EG0025 affected58 at risk
Chills	General disorders	MedDRA (7.1)	Systematic Assessment	EG00015 affected103 at risk EG0010 affected104 at risk EG0023 affected58 at risk
Fatigue	General disorders	MedDRA (7.1)	Systematic Assessment	EG00022 affected103 at risk EG00110 affected104 at risk EG0024 affected58 at risk
Oedema peripheral	General disorders	MedDRA (7.1)	Systematic Assessment	EG0007 affected103 at risk EG0012 affected104 at risk EG0024 affected58 at risk
Pyrexia	General disorders	MedDRA (7.1)	Systematic Assessment	EG00017 affected103 at risk EG0016 affected104 at risk EG0024 affected58 at risk
Influenza	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG0007 affected103 at risk EG0014 affected104 at risk EG0021 affected58 at risk
Nasopharyngitis	Infections and infestations	MedDRA (7.1)	Systematic Assessment	EG00017 affected103 at risk EG0012 affected104 at risk EG0022 affected58 at risk
Weight decreased	Investigations	MedDRA (7.1)	Systematic Assessment	EG0009 affected103 at risk EG0014 affected104 at risk EG0023 affected58 at risk
Weight increased	Investigations	MedDRA (7.1)	Systematic Assessment	EG0009 affected103 at risk EG0014 affected104 at risk EG0021 affected58 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (7.1)	Systematic Assessment	EG0007 affected103 at risk EG0012 affected104 at risk EG0023 affected58 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG00015 affected103 at risk EG0019 affected104 at risk EG0023 affected58 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG00015 affected103 at risk EG0017 affected104 at risk EG0023 affected58 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG00011 affected103 at risk EG0016 affected104 at risk EG0022 affected58 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG00013 affected103 at risk EG0013 affected104 at risk EG0023 affected58 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0003 affected103 at risk EG0012 affected104 at risk EG0024 affected58 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0006 affected103 at risk EG0014 affected104 at risk EG0023 affected58 at risk
Dizziness	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG00010 affected103 at risk EG0014 affected104 at risk EG0022 affected58 at risk
Headache	Nervous system disorders	MedDRA (7.1)	Systematic Assessment	EG00014 affected103 at risk EG0016 affected104 at risk EG0022 affected58 at risk
Depression	Psychiatric disorders	MedDRA (7.1)	Systematic Assessment	EG0006 affected103 at risk EG0011 affected104 at risk EG0020 affected58 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG00015 affected103 at risk EG0016 affected104 at risk EG0024 affected58 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (7.1)	Systematic Assessment	EG00014 affected103 at risk EG0019 affected104 at risk EG0024 affected58 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0004 affected103 at risk EG0012 affected104 at risk EG0026 affected58 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (7.1)	Systematic Assessment	EG0006 affected103 at risk EG0016 affected104 at risk EG0021 affected58 at risk
Hot flush	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0009 affected103 at risk EG0013 affected104 at risk EG0020 affected58 at risk
Hypertension	Vascular disorders	MedDRA (7.1)	Systematic Assessment	EG0006 affected103 at risk EG0014 affected104 at risk EG0022 affected58 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (7.1)	Systematic Assessment	EG0000 affected103 at risk EG0010 affected104 at risk EG0023 affected58 at risk
Lacrimation increased	Eye disorders	MedDRA (7.1)	Systematic Assessment	EG0001 affected103 at risk EG0010 affected104 at risk EG0024 affected58 at risk
Mucosal inflammation	General disorders	MedDRA (7.1)	Systematic Assessment	EG0005 affected103 at risk EG0010 affected104 at risk EG0024 affected58 at risk

Ancestor Terms

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
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85006	United States

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