A Study of Avastin (Bevacizumab) Plus Taxane-Based Therap... | NCT00448591

NCT00448591

Status Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: bevacizumab [Avastin] Drug: Taxane-based chemotherapy

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab [Avastin]	Drug	10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle	1

Measure	Description	Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)	Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.	Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion

Measure	Description	Time Frame
Percentage of Participants With Disease Progression	Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.	Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

PubMed Identifier	Type	Citation	Retractions
25047747	Derived	Llombart-Cussac A, Pivot X, Biganzoli L, Cortes-Funes H, Pritchard KI, Pierga JY, Smith I, Thomssen C, Srock S, Sampayo M, Cortes J. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast. 2014 Oct;23(5):656-62. doi: 10.1016/j.breast.2014.06.017. Epub 2014 Jul 19.
22490570

ID	Title	Description
FG000	Bevacizumab	Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy or in combination with other chemotherapy as prescribed.

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

Secondary

Percentage of Participants With Disease Progression

Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

ITT Population

Posted

Number

percentage of participants

Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

ID	Title	Description
OG000	Bevacizumab	Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed

Units	Counts
Participants	OG0002264

Title

Denominators

Categories

Title	Measurements
	OG00072.44

Secondary

Time to Progression (TTP)

TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.

ITT Population

Posted

Median

Full Range

months

Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

ID	Title	Description
OG000	Bevacizumab	Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Recorded Death

ITT Population

Posted

Number

percentage of participants

Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

ID	Title	Description
OG000	Bevacizumab	Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed

Units	Counts
Participants	OG0002264

Secondary

Overall Survival

Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.

ITT Population

Posted

Median

Full Range

months

Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months

ID	Title	Description
OG000	Bevacizumab	Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed

Units	Counts
Participants	OG000

Secondary

Percentage of Participants by Best Overall Response to Treatment

Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.

ITT Population

Posted

Number

percentage of participants

Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

ID	Title	Description
OG000	Bevacizumab	Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed

Units	Counts
Participants	OG000

Primary

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)

Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.

Safety Population

Posted

Number

percentage of participants

Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion

ID	Title	Description
OG000	Bevacizumab	Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG000117 affected2,264 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00098 affected2,264 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00014 affected2,264 at risk
Pneumonia	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00017 affected2,264 at risk
Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00015 affected2,264 at risk
Sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00017 affected2,264 at risk
Device related infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00016 affected2,264 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00020 affected2,264 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00013 affected2,264 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00023 affected2,264 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00021 affected2,264 at risk
Pyrexia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG00026 affected2,264 at risk
Hypertension	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG00016 affected2,264 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG00012 affected2,264 at risk
Neutrophil count decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0008 affected2,264 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0008 affected2,264 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0006 affected2,264 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected2,264 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0008 affected2,264 at risk
Anal abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected2,264 at risk
Abscess limb	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Diverticulitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Erysipelas	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Bronchitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Cellulitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Febrile infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Lower respiratory infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Appendicitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Catheter site infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Herpes zoster	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Lung infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Soft tissue infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Abscess soft tissue	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Anal infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Arthritis infective	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Catheter sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Clostridial infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Endocarditis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Escherichia infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Infected cyst	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Influenza	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Kidney infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Laryngitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Liver abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Neutropenic infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Osteomyelitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Otitis media	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Parotid abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Perianal abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Periodontal infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Peritonsillar abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Postoperative wound infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pseudomonas infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pyelonephritis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Renal cyst infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Respiratory moniliasis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Septic shock	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Sinusitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Skin infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Tonsillitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Tooth infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Tuberculous pleurisy	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Urosepsis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Varicella	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Viral infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Wound abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Depression	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Confusional state	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Acute psychosis	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Drug abuse	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Insomnia related to another mental condition	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Major depression	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Mental disorder	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Mastectomy	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Hepatectomy	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Breast lump removal	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Catheter removal	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hip surgery	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Laryngeal operation	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Thoractomy	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Leukocytoclastic vasculitis	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Diplopia	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Blindness	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Keratitis	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pupils unequal	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Retinal detachment	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Metastases to bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Uterine disorder	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Uterine prolapse	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hypersensitivity	Immune system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Deafness	Ear and labyrinth disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected2,264 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0007 affected2,264 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0006 affected2,264 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected2,264 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Subileus	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Ascites	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Colitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Dental caries	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Enteritis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastritis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gingivitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Melaena	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Oesophageal fistula	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Proctocolitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Sigmoiditis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected2,264 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected2,264 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0006 affected2,264 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected2,264 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hypoventilation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Non-cardiogenic pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Impaired healing	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected2,264 at risk
Chest pain	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0006 affected2,264 at risk
General physical health deterioration	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0006 affected2,264 at risk
Asthenia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected2,264 at risk
Fatigue	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Malaise	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Pain	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Death	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Oedema peripheral	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Aplasia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Discomfort	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Extravasation	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hyperthermia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Mucosal inflammation	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Necrosis	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pelvic mass	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Haemorrhage	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Hypertensive crisis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Phlebitis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Venous thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Aortic stenosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Axillary vein thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Haemodynamic instability	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Headache	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0006 affected2,264 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Convulsion	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Facial palsy	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Dizziness	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Hemiparesis	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Paraesthesia	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Syncope	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cerebral microangiopathy	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cranial nerve paralysis	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Epilepsy	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Movement disorder	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Optic neuritis retrobulbar	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Paraplegia	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pneumocephalus	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Presyncope	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cardiac failure	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Myocardial infarction	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Angina unstable	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Cardiac arrest	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Palpitations	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Arrhythmia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Atrial flutter	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cardiotoxicity	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Coronary artery disease	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Pericardial effusion	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Tachycardia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hepatic atrophy	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hepatic functional abnormal	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Jaundice hepatocellular	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Proteinuria	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected2,264 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Renal failure	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Haematuria	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hydroureter	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Obstrucive uropathy	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Renal colic	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Urethral pain	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
White blood cell count decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Haemoglobin decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Platelet count decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Transaminases increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Granulocyte count decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Neutrophil count abnormal	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Scan myocardial perfusion abnormal	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
White blood cell count abnormal	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Device breakage	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Device leakage	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Haemothorax	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hepatic rupture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Radiation injury	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Thrombosis in device	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0008 affected2,264 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0006 affected2,264 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Joint destruction	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected2,264 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected2,264 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected2,264 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected2,264 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Gout	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected2,264 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Stomatitis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000657 affected2,264 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000667 affected2,264 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000613 affected2,264 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000415 affected2,264 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000352 affected2,264 at risk
Fatigue	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001,111 affected2,264 at risk
Pyrexia	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG000361 affected2,264 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000934 affected2,264 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000272 affected2,264 at risk
Neutrophil count decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000587 affected2,264 at risk
White blood cell count decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000566 affected2,264 at risk
Haemoglobin decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000416 affected2,264 at risk
Alanine aminotransferase increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000293 affected2,264 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000259 affected2,264 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000867 affected2,264 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000338 affected2,264 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000312 affected2,264 at risk
Neuropathy	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG000446 affected2,264 at risk
Headache	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG000409 affected2,264 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000339 affected2,264 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000305 affected2,264 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000270 affected2,264 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000277 affected2,264 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000247 affected2,264 at risk
Hypertension	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG000760 affected2,264 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG000423 affected2,264 at risk
Proteinuria	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG000618 affected2,264 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG000144 affected2,264 at risk
Lacrimation increased	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG000212 affected2,264 at risk
Insomnia	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG000136 affected2,264 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000210 affected2,264 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000153 affected2,264 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000131 affected2,264 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000119 affected2,264 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000198 affected2,264 at risk
Oedema peripheral	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG000202 affected2,264 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000234 affected2,264 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG000207 affected2,264 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000202 affected2,264 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000184 affected2,264 at risk
Platelet count decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000166 affected2,264 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG000114 affected2,264 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG000149 affected2,264 at risk
Dysgeusia	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG000168 affected2,264 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG000165 affected2,264 at risk
Paraesthesia	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG000158 affected2,264 at risk
Dizziness	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG000120 affected2,264 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG000142 affected2,264 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG000124 affected2,264 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Buenos Aires		1406	Argentina

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