A Study of Bevacizumab (Avastin) in Women With HER2 Negat... | NCT00333775

NCT00333775

ID	Type	Description	Link
2005-003862-40	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Docetaxel 100 mg/m^2 plus placebo	Experimental	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.	Drug: Docetaxel Drug: Placebo to bevacizumab
Docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg	Experimental	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.	Drug: Docetaxel Drug: Bevacizumab
Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg	Experimental	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.	Drug: Docetaxel Drug: Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel	Drug	Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.	Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival	Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).	Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a Complete Response or a Partial Response	Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Adelaide	New South Wales	5011	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29522361	Derived	Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Docetaxel 100 mg/m^2 Plus Placebo	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Docetaxel 100 mg/m^2 Plus Placebo	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
BG001	Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
BG002	Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0008.0(7.2 to 8.3) OG0018.7(8.2 to 9.9) OG0028.8(8.4 to 10.2)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.0318		Hazard Ratio (HR)	0.79			2-Sided	95	0.63	0.98				No	Superiority or Other
OG000 OG002		Log Rank		0.0036

Secondary

Percentage of Participants With a Complete Response or a Partial Response

Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline were included in the analysis.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

ID	Title	Description
OG000	Docetaxel 100 mg/m^2 Plus Placebo	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
OG001	Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Secondary

Duration of Response

Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.

Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not. Only participants with measurable disease at Baseline who had a complete response or a partial response were included in the analysis.

Posted

Median

95% Confidence Interval

Months

Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)

ID	Title	Description
OG000	Docetaxel 100 mg/m^2 Plus Placebo	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
OG001	Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Secondary

Time to Treatment Failure

Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.

Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.

Posted

Median

95% Confidence Interval

months

Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)

ID	Title	Description
OG000	Docetaxel 100 mg/m^2 Plus Placebo	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
OG001	Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
OG002

Secondary

Overall Survival

Overall survival was defined as the time from randomization to death from any cause.

Intent-to-treat population: All randomized participants, regardless of whether they received study drug or not.

Posted

Median

95% Confidence Interval

Months

Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

ID	Title	Description
OG000	Docetaxel 100 mg/m^2 Plus Placebo	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
OG001	Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
OG002	Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Docetaxel 100 mg/m^2 Plus Placebo	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.	82	217	216	217
EG001	Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.	106	252	251	252
EG002	Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg	Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.	120	261	260	261

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00021 affected217 at risk EG00129 affected252 at risk EG00237 affected261 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected217 at risk EG00113 affected252 at risk EG00218 affected261 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0013 affected252 at risk EG0021 affected261 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0005 affected217 at risk EG0013 affected252 at risk EG0022 affected261 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0013 affected252 at risk EG0022 affected261 at risk
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0004 affected217 at risk EG0012 affected252 at risk EG0021 affected261 at risk
Neutropenic infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0012 affected252 at risk EG0021 affected261 at risk
Anal abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected252 at risk EG0022 affected261 at risk
Central line infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected252 at risk EG0022 affected261 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0013 affected252 at risk EG0020 affected261 at risk
Sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0022 affected261 at risk
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Clostridial infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Paronychia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0022 affected261 at risk
Postoperative wound infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected252 at risk EG0020 affected261 at risk
Anal infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Anorectal infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Appendicitis perforated	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Arthritis infective	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Bacteraemia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Bacterial sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Breast abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Bronchitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Catheter bacteraemia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Catheter related infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Catheter sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Diverticulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Endophthalmitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Erysipelas	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Lung abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Lung infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Nail bed infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Oral candidiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Periodontal infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Purulent discharge	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Septic shock	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Sinusitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Stent related infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Wound infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected217 at risk EG0016 affected252 at risk EG0028 affected261 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected217 at risk EG0013 affected252 at risk EG0022 affected261 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0013 affected252 at risk EG0024 affected261 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0012 affected252 at risk EG0023 affected261 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0022 affected261 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected252 at risk EG0020 affected261 at risk
Ileus	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0022 affected261 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Colitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Enteritis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Gastritis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected217 at risk EG0016 affected252 at risk EG0027 affected261 at risk
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0016 affected252 at risk EG0024 affected261 at risk
Mucosal inflammation	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected252 at risk EG0022 affected261 at risk
Oedema peripheral	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected252 at risk EG0020 affected261 at risk
General physical health deterioration	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Catheter related complication	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Death	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Face oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Ill-defined disorder	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Impaired healing	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Inflammation	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Multi-organ failure	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0013 affected252 at risk EG0023 affected261 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected252 at risk EG0023 affected261 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected217 at risk EG0010 affected252 at risk EG0022 affected261 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Nasal septum ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0023 affected261 at risk
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0013 affected252 at risk EG0020 affected261 at risk
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Nervous system disorder	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Cerebral infarction	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Convulsion	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Cranial nerve palsies multiple	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Migraine	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Presyncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0012 affected252 at risk EG0022 affected261 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Microangiopathy	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Embolism venous	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Flushing	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Hypertensive crisis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Phlebitis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Thrombophlebitis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Venous thrombosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Narcotic intoxication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0013 affected252 at risk EG0021 affected261 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0022 affected261 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Arrhythmia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Cardiac failure	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Myocardial infarction	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Hepatorenal failure	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Hypersensitivity	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0022 affected261 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0021 affected261 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Cataract	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Visual acuity reduced	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Vitreous detachment	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Inflammatory carcinoma of the breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Renal colic	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Renal failure	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected217 at risk EG0010 affected252 at risk EG0020 affected261 at risk
Central venous catheter removal	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0010 affected252 at risk EG0021 affected261 at risk
Vertebroplasty	Surgical and medical procedures	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Depression	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Mood altered	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected217 at risk EG0011 affected252 at risk EG0020 affected261 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG00096 affected217 at risk EG001105 affected252 at risk EG002109 affected261 at risk
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment	EG00083 affected217 at risk EG00188 affected252 at risk EG00297 affected261 at risk
Mucosal inflammation	General disorders	MedDRA 16.1	Systematic Assessment	EG00048 affected217 at risk EG00187 affected252 at risk EG00278 affected261 at risk
Oedema peripheral	General disorders	MedDRA 16.1	Systematic Assessment	EG00089 affected217 at risk EG00163 affected252 at risk EG00261 affected261 at risk
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG00045 affected217 at risk EG00161 affected252 at risk EG00263 affected261 at risk
Oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG00032 affected217 at risk EG00112 affected252 at risk EG00221 affected261 at risk
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG00020 affected217 at risk EG00116 affected252 at risk EG00216 affected261 at risk
Chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG00019 affected217 at risk EG00110 affected252 at risk EG00220 affected261 at risk
Malaise	General disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected217 at risk EG00110 affected252 at risk EG00215 affected261 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG000154 affected217 at risk EG001181 affected252 at risk EG002183 affected261 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00087 affected217 at risk EG001118 affected252 at risk EG002118 affected261 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00047 affected217 at risk EG00180 affected252 at risk EG00270 affected261 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00043 affected217 at risk EG00143 affected252 at risk EG00247 affected261 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00032 affected217 at risk EG00133 affected252 at risk EG00225 affected261 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00020 affected217 at risk EG00126 affected252 at risk EG00233 affected261 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00019 affected217 at risk EG00128 affected252 at risk EG00223 affected261 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0009 affected217 at risk EG00121 affected252 at risk EG00225 affected261 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected217 at risk EG00121 affected252 at risk EG00220 affected261 at risk
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00015 affected217 at risk EG00116 affected252 at risk EG00212 affected261 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected217 at risk EG00114 affected252 at risk EG00210 affected261 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG000106 affected217 at risk EG001143 affected252 at risk EG002140 affected261 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG000117 affected217 at risk EG001115 affected252 at risk EG002132 affected261 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00060 affected217 at risk EG001127 affected252 at risk EG002115 affected261 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00064 affected217 at risk EG00189 affected252 at risk EG00277 affected261 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00059 affected217 at risk EG00164 affected252 at risk EG00275 affected261 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00039 affected217 at risk EG00145 affected252 at risk EG00258 affected261 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00027 affected217 at risk EG00136 affected252 at risk EG00243 affected261 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00034 affected217 at risk EG00124 affected252 at risk EG00232 affected261 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00014 affected217 at risk EG00122 affected252 at risk EG00222 affected261 at risk
Toothache	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00013 affected217 at risk EG00113 affected252 at risk EG00214 affected261 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00012 affected217 at risk EG00113 affected252 at risk EG00213 affected261 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected217 at risk EG00115 affected252 at risk EG00212 affected261 at risk
Gingivitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected217 at risk EG00111 affected252 at risk EG00216 affected261 at risk
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00056 affected217 at risk EG00186 affected252 at risk EG00279 affected261 at risk
Dysgeusia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00059 affected217 at risk EG00177 affected252 at risk EG00263 affected261 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00060 affected217 at risk EG00167 affected252 at risk EG00263 affected261 at risk
Paraesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00040 affected217 at risk EG00146 affected252 at risk EG00251 affected261 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00030 affected217 at risk EG00135 affected252 at risk EG00226 affected261 at risk
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00025 affected217 at risk EG00126 affected252 at risk EG00231 affected261 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected217 at risk EG0012 affected252 at risk EG0026 affected261 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00080 affected217 at risk EG00182 affected252 at risk EG00288 affected261 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00048 affected217 at risk EG00174 affected252 at risk EG00290 affected261 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00037 affected217 at risk EG00156 affected252 at risk EG00244 affected261 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00045 affected217 at risk EG00136 affected252 at risk EG00244 affected261 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00038 affected217 at risk EG00135 affected252 at risk EG00242 affected261 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00023 affected217 at risk EG00134 affected252 at risk EG00236 affected261 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected217 at risk EG00114 affected252 at risk EG00217 affected261 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG00013 affected217 at risk EG00112 affected252 at risk EG00212 affected261 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0009 affected217 at risk EG00116 affected252 at risk EG0029 affected261 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00047 affected217 at risk EG001123 affected252 at risk EG002128 affected261 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00042 affected217 at risk EG00167 affected252 at risk EG00261 affected261 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00049 affected217 at risk EG00144 affected252 at risk EG00260 affected261 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00019 affected217 at risk EG00126 affected252 at risk EG00238 affected261 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00019 affected217 at risk EG00127 affected252 at risk EG00228 affected261 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00010 affected217 at risk EG00124 affected252 at risk EG00228 affected261 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00013 affected217 at risk EG00110 affected252 at risk EG00217 affected261 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected217 at risk EG00113 affected252 at risk EG00212 affected261 at risk
Lacrimation increased	Eye disorders	MedDRA 16.1	Systematic Assessment	EG00063 affected217 at risk EG001114 affected252 at risk EG002120 affected261 at risk
Conjunctivitis	Eye disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected217 at risk EG00116 affected252 at risk EG00239 affected261 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00023 affected217 at risk EG00122 affected252 at risk EG00228 affected261 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00014 affected217 at risk EG00120 affected252 at risk EG00235 affected261 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00018 affected217 at risk EG00127 affected252 at risk EG00220 affected261 at risk
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG00012 affected217 at risk EG00126 affected252 at risk EG00215 affected261 at risk
Rhinitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0009 affected217 at risk EG00111 affected252 at risk EG00218 affected261 at risk
Sinusitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0008 affected217 at risk EG00110 affected252 at risk EG00219 affected261 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00044 affected217 at risk EG00151 affected252 at risk EG00253 affected261 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00037 affected217 at risk EG00134 affected252 at risk EG00232 affected261 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00014 affected217 at risk EG00121 affected252 at risk EG00220 affected261 at risk
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00032 affected217 at risk EG00144 affected252 at risk EG00266 affected261 at risk
Hot flush	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00016 affected217 at risk EG00116 affected252 at risk EG00219 affected261 at risk
Flushing	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00012 affected217 at risk EG00115 affected252 at risk EG00219 affected261 at risk
Lymphoedema	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG00015 affected217 at risk EG00119 affected252 at risk EG0028 affected261 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00058 affected217 at risk EG00178 affected252 at risk EG00285 affected261 at risk
Insomnia	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG00034 affected217 at risk EG00131 affected252 at risk EG00235 affected261 at risk
Depression	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected217 at risk EG00113 affected252 at risk EG00213 affected261 at risk
Anxiety	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected217 at risk EG00111 affected252 at risk EG00216 affected261 at risk
Weight decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG00012 affected217 at risk EG00129 affected252 at risk EG00230 affected261 at risk
Weight increased	Investigations	MedDRA 16.1	Systematic Assessment	EG00016 affected217 at risk EG0015 affected252 at risk EG0027 affected261 at risk
Proteinuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected217 at risk EG00112 affected252 at risk EG00224 affected261 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG00010 affected217 at risk EG00111 affected252 at risk EG00215 affected261 at risk

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

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