Study To Evaluate the Efficacy and Safety Of Bevacizumab,... | NCT01663727

ID	Type	Description	Link
2011-005335-97	EudraCT Number

Label	Type	Description	Intervention Names
A	Experimental	Paclitaxel + Bevacizumab [Avastin]	Drug: Bevacizumab [Avastin] Drug: Paclitaxel
B	Experimental	Paclitaxel + Placebo	Drug: Paclitaxel Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab [Avastin]	Drug	Intravenous repeating dose	A
Paclitaxel

Measure	Description	Time Frame
Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population	Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.	Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Progression Free Survival (PFS) in ITT Population	PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.	Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)
Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population	Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.	Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)
PFS in High Baseline Plasma VEGF-A ITT Population	PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.

Measure	Description	Time Frame
Percentage of Participants Who Died - ITT Population		From randomization till death or clinical cut-off (up to 244 weeks)
Overall Survival (OS) - ITT Population	OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Arizona Cancer Center

PubMed Identifier	Type	Citation	Retractions
28158579	Derived	Masuda N, Takahashi M, Nakagami K, Okumura Y, Nakayama T, Sato N, Kanatani K, Tajima K, Kashiwaba M. First-line bevacizumab plus paclitaxel in Japanese patients with HER2-negative metastatic breast cancer: subgroup results from the randomized Phase III MERiDiAN trial. Jpn J Clin Oncol. 2017 May 1;47(5):385-392. doi: 10.1093/jjco/hyx001.
27817944

ID	Title	Description
FG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
FG001	Paclitaxel+ Bevacizumab

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population

Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.

ITT population.

Posted

Number

percentage of participants

Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Units	Counts
Participants	OG000242 OG001239

Title

Denominators

Categories

Title	Measurements
	OG00069.4 OG00163.6

Primary

Progression Free Survival (PFS) in ITT Population

PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.

ITT population.

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Secondary

Percentage of Participants Who Died - ITT Population

ITT Population.

Posted

Number

percentage of participants

From randomization till death or clinical cut-off (up to 244 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS) - ITT Population

OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.

ITT population.

Posted

Median

95% Confidence Interval

months

From randomization till death or clinical cut-off (up to 244 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population

High Baseline Plasma VEGF-A ITT Population.

Posted

Number

percentage of participants

From randomization till death or clinical cut-off (up to 244 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Units	Counts
Participants	OG000

Secondary

OS - High Baseline Plasma VEGF-A ITT Population

OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.

High Baseline Plasma VEGF-A ITT population.

Posted

Median

95% Confidence Interval

months

From randomization till death or clinical cut-off (up to 244 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With an Objective Response - ITT Population

Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).

Number of participants analyzed=participants from ITT population with measurable disease at baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Primary

Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population

Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.

High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.

Posted

Number

percentage of participants

Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Primary

PFS in High Baseline Plasma VEGF-A ITT Population

High baseline plasma VEGF-A ITT population.

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Secondary

Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population

Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.

Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Secondary

Duration of Response - ITT Population

Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.

Number of participants analyzed=participants from ITT population who had an objective response.

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab

Secondary

Duration of Response - High Baseline Plasma VEGF-A ITT Population

Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.

Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001

Secondary

Percentage of Participants Who Were Alive at 1 Year - ITT Population

ITT Population.

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Units	Counts
Participants	OG000

Secondary

Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population

High Baseline Plasma VEGF-A ITT Population

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
OG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 events2 affected233 at risk EG0013 events1 affected238 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0014 events4 affected238 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0011 events1 affected238 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Optic nerve disorder	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Visual acuity reduced	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 events4 affected233 at risk EG0013 events2 affected238 at risk
Colitis	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Constipation	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0012 events1 affected238 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0012 events2 affected238 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Enteritis	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Gastric varices haemorrhage	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Nausea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0014 events4 affected238 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Vomiting	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 events3 affected233 at risk EG0014 events4 affected238 at risk
Asthenia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Death	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Influenza like illness	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Malaise	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Mucosal inflammation	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Pyrexia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Sudden death	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Gallbladder pain	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0003 events1 affected233 at risk EG0010 events0 affected238 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0013 events3 affected238 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Abdominal wall abscess	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Abscess	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Abscess limb	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Appendicitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0012 events2 affected238 at risk
Cellulitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0016 events4 affected238 at risk
Cholecystitis infective	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Colonic abscess	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Cystitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Device related infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected233 at risk EG0013 events3 affected238 at risk
Device related sepsis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected238 at risk
Gastroenteritis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Influenza	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0012 events2 affected238 at risk
Lung infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Peritonitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Pneumonia	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0004 events3 affected233 at risk EG0014 events4 affected238 at risk
Pneumonia necrotising	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Sepsis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0012 events2 affected238 at risk
Sepsis syndrome	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Septic shock	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Urinary tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0012 events2 affected238 at risk
Wound infection bacterial	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0012 events2 affected238 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0012 events2 affected238 at risk
Urine output decreased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected233 at risk EG0010 events0 affected238 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0014 events4 affected238 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Dementia	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Dizziness	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Hemiparesis	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Loss of consciousness	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Speech disorder	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Spinal cord compression	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 events0 affected238 at risk
Syncope	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0014 events3 affected238 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Haematuria	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected233 at risk EG0010 events0 affected238 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected233 at risk EG0010 events0 affected238 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0014 events4 affected238 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected233 at risk EG0010 events0 affected238 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Aortic stenosis	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0002 events2 affected233 at risk EG0010 events0 affected238 at risk
Embolism venous	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
CATARACT	Eye disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
CATHETER SITE ERYTHEMA	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0012 events1 affected238 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
VIRAL INFECTION	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
CATHETER SITE INFECTION	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
KLEBSIELLA SEPSIS	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
SOFT TISSUE INFECTION	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0001 events1 affected233 at risk EG0010 events0 affected238 at risk
STERNAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk
ARTERIAL THROMBOSIS	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 events0 affected233 at risk EG0011 events1 affected238 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00082 events39 affected233 at risk EG00163 events39 affected238 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00042 events14 affected233 at risk EG00141 events17 affected238 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (17.1)	Non-systematic Assessment	EG000124 events50 affected233 at risk EG001254 events77 affected238 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00030 events17 affected233 at risk EG00127 events20 affected238 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00014 events13 affected233 at risk EG00116 events13 affected238 at risk
Constipation	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00070 events50 affected233 at risk EG001108 events67 affected238 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG000128 events72 affected233 at risk EG001189 events88 affected238 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00020 events16 affected233 at risk EG00140 events23 affected238 at risk
Nausea	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG000205 events75 affected233 at risk EG001310 events99 affected238 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00035 events26 affected233 at risk EG00175 events42 affected238 at risk
Toothache	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0009 events8 affected233 at risk EG00116 events15 affected238 at risk
Vomiting	Gastrointestinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00063 events36 affected233 at risk EG00196 events47 affected238 at risk
Asthenia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00050 events36 affected233 at risk EG00162 events32 affected238 at risk
Fatigue	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG000123 events74 affected233 at risk EG001156 events88 affected238 at risk
Oedema peripheral	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00057 events42 affected233 at risk EG00156 events41 affected238 at risk
Pyrexia	General disorders	MedDRA (17.1)	Non-systematic Assessment	EG00037 events28 affected233 at risk EG00159 events34 affected238 at risk
Bronchitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG00012 events12 affected233 at risk EG00114 events11 affected238 at risk
Nasopharyngitis	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG00065 events36 affected233 at risk EG00154 events24 affected238 at risk
Paronychia	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0009 events7 affected233 at risk EG00113 events13 affected238 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG00014 events11 affected233 at risk EG00126 events25 affected238 at risk
Urinary tract infection	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG00022 events16 affected233 at risk EG00147 events35 affected238 at risk
Alanine aminotransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG00021 events17 affected233 at risk EG00137 events21 affected238 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG00019 events16 affected233 at risk EG00132 events21 affected238 at risk
Neutrophil count decreased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG000100 events20 affected233 at risk EG00156 events15 affected238 at risk
White blood cell count decreased	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG00084 events16 affected233 at risk EG00187 events21 affected238 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG00065 events42 affected233 at risk EG00191 events55 affected238 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (17.1)	Non-systematic Assessment	EG00013 events10 affected233 at risk EG00122 events15 affected238 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00086 events53 affected233 at risk EG00191 events53 affected238 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00042 events31 affected233 at risk EG00132 events26 affected238 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00032 events20 affected233 at risk EG00117 events11 affected238 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00060 events28 affected233 at risk EG00183 events43 affected238 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00023 events21 affected233 at risk EG00132 events23 affected238 at risk
Dizziness	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00025 events24 affected233 at risk EG00133 events28 affected238 at risk
Dysgeusia	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00024 events22 affected233 at risk EG00143 events33 affected238 at risk
Headache	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00071 events44 affected233 at risk EG00185 events51 affected238 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00067 events50 affected233 at risk EG00172 events47 affected238 at risk
Paraesthesia	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG00021 events17 affected233 at risk EG00114 events12 affected238 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG000107 events84 affected233 at risk EG001129 events92 affected238 at risk
Anxiety	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG00015 events15 affected233 at risk EG0018 events8 affected238 at risk
Insomnia	Psychiatric disorders	MedDRA (17.1)	Non-systematic Assessment	EG00024 events20 affected233 at risk EG00146 events35 affected238 at risk
Proteinuria	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG00033 events26 affected233 at risk EG00153 events32 affected238 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00038 events30 affected233 at risk EG00159 events43 affected238 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 events5 affected233 at risk EG00124 events19 affected238 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00033 events30 affected233 at risk EG00141 events33 affected238 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00077 events48 affected233 at risk EG001158 events97 affected238 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG00015 events14 affected233 at risk EG00123 events18 affected238 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0004 events3 affected233 at risk EG00126 events20 affected238 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG000159 events145 affected233 at risk EG001149 events140 affected238 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0007 events7 affected233 at risk EG00120 events18 affected238 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00018 events18 affected233 at risk EG00137 events33 affected238 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00013 events13 affected233 at risk EG00114 events13 affected238 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0006 events6 affected233 at risk EG00117 events15 affected238 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00012 events10 affected233 at risk EG00117 events15 affected238 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG00036 events31 affected233 at risk EG001113 events58 affected238 at risk
Hot flush	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG00030 events10 affected233 at risk EG00117 events15 affected238 at risk
Hypertension	Vascular disorders	MedDRA (17.1)	Non-systematic Assessment	EG00083 events30 affected233 at risk EG001109 events73 affected238 at risk
SINUSITIS	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG00012 events8 affected233 at risk EG00115 events12 affected238 at risk
WEIGHT DECREASED	Investigations	MedDRA (17.1)	Non-systematic Assessment	EG0005 events5 affected233 at risk EG00113 events12 affected238 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0005 events3 affected233 at risk EG00113 events12 affected238 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0008 events5 affected233 at risk EG00114 events12 affected238 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue 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
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
BG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
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	Paclitaxel+Placebo	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.	162	233	45	233	225	233
EG001	Paclitaxel+ Bevacizumab	Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.	161	238	66	238	230	238