Study of Cisplatin/Vinorelbine +/- Cetuximab as First-lin... | NCT00148798

NCT00148798

Status Module

Oversight 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
Cetuximab plus chemotherapy	Experimental	cetuximab + cisplatin + vinorelbine	Drug: cetuximab + cisplatin + vinorelbine
Chemotherapy alone	Active Comparator	cisplatin + vinorelbine alone	Drug: cisplatin + vinorelbine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cetuximab + cisplatin + vinorelbine	Drug	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival Time (OS)	Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.	Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival Time	Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.	Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Robert Pirker, Professor	Universitätsklinik für Innere Medizin I, Wien	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Buenos Aires			Argentina
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19410716	Result	Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.
22498112

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
BG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00059(18 to 78) BG00160(20 to 83) BG00259(18 to 83)

Age, Customized

Number

participants

Title

Denominators

Categories

<18 years

Title	Measurements
	BG0000 BG0010 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000172 BG001163 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Australia

Title	Measurements
	BG00020 BG00123 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival Time (OS)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

ITT

Posted

Median

95% Confidence Interval

months

Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
OG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.

Units	Counts
Participants	OG000557 OG001568

Title

Denominators

Categories

Title	Measurements
	OG00011.3(9.4 to 12.4) OG00110.1(9.1 to 10.9)

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	Primary efficacy analysis: To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (Stage IIIb vs IV, ECOG 0/1 vs 2) (α=5%).	Stratified Log Rank		0.0441						2-Sided	95						No	Superiority or Other

Secondary

Progression-free Survival Time

Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.

ITT

Posted

Median

95% Confidence Interval

months

Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
OG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.

Units	Counts

Secondary

Best Overall Response Rate

The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).

Posted

Number

95% Confidence Interval

percentage of participants

Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
OG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.

Units	Counts
Participants

Secondary

Disease Control Rate

The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).

ITT

Posted

Number

95% Confidence Interval

percentage of participants

Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
OG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.

Units	Counts

Secondary

Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status

Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.

670 subjects completed (348 in the cetuximab + chemotherapy arm and 322 in the chemotherapy alone arm) at least 1 evaluable QLQ-C30 questionnaire and were included in the Evaluable population. Numbers at each timepoint were (Cetuximab + chemotherapy/Chemotherapy alone, respectively): baseline 278/274; cycle 3 184/153; 6 month 102/96

Posted

Least Squares Mean

Standard Error

scores on a scale

at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
OG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.

Secondary

Quality of Life Assessment (EORTC QLQ-C30) Social Functioning

Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.

Posted

Least Squares Mean

Standard Error

scores on a scale

at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
OG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.

Secondary

A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations

Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.

Posted

Mean

Standard Deviation

ug/mL

Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.

ID	Title	Description
OG000	Cetuximab Concentration at End of Infusion Week 1
OG001	Cetuximab Concentration Before Infusion Week 7

Units	Counts
Participants	OG000

Secondary

Safety - Number of Patients Experiencing Any Adverse Event

Please refer to Adverse Events section for further details

Safety Population

Posted

Number

participants

time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

ID	Title	Description
OG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.
OG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cetuximab Plus Chemotherapy	cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.			325	548	532	548
EG001	Chemotherapy Alone	cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle. Safety population: includes all treated subjects.			244	562	537	562

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00011 affected548 at risk EG00112 affected562 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected548 at risk EG0010 affected562 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00096 affected548 at risk EG00167 affected562 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0011 affected562 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00015 affected548 at risk EG0018 affected562 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00047 affected548 at risk EG00133 affected562 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected548 at risk EG0010 affected562 at risk
Angina pectoris	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0014 affected562 at risk
Cardiac arrest	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Cardiac failure	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0012 affected562 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Cardiac tamponade	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected548 at risk EG0013 affected562 at risk
Left ventricular failure	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Microvascular angina	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0011 affected562 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Palpitations	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Pericardial effusion	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0012 affected562 at risk
Right ventricular failure	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Tachycardia	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Deafness	Ear and labyrinth disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0006 affected548 at risk EG0018 affected562 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0011 affected562 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Colitis	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Constipation	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected548 at risk EG0016 affected562 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0008 affected548 at risk EG0015 affected562 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Enteritis	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Melaena	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0006 affected548 at risk EG0015 affected562 at risk
Odynophagia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Retinal detachment	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected548 at risk EG0011 affected562 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00016 affected548 at risk EG00114 affected562 at risk
Asthenia	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected548 at risk EG0012 affected562 at risk
Chest discomfort	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Chest pain	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0007 affected548 at risk EG0016 affected562 at risk
Death	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Drug interaction	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Fatigue	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected548 at risk EG0012 affected562 at risk
Gait disturbance	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
General physical health deterioration	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00022 affected548 at risk EG0014 affected562 at risk
Injection site reaction	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Malaise	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Mucosal inflammation	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0011 affected562 at risk
Multi-organ failure	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Oedema	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Pain	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Performance status decreased	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00016 affected548 at risk EG0016 affected562 at risk
Sudden death	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected548 at risk EG0010 affected562 at risk
Anaphylactic shock	Immune system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hypersensitivity	Immune system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected548 at risk EG0011 affected562 at risk
Serum sickness	Immune system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Anal abscess	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Bacteraemia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Bacterial sepsis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Brain abscess	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Bronchitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0012 affected562 at risk
Bronchitis bacterial	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Bronchopneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Catheter related infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected548 at risk EG0010 affected562 at risk
Cellulitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected548 at risk EG0010 affected562 at risk
Central line infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Clostridial infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Dengue fever	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Diverticulitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Febrile infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Gangrene	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Gastroenteritis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected548 at risk EG0011 affected562 at risk
Laryngitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Laryngotracheo bronchitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Lobar pneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected548 at risk EG0012 affected562 at risk
Lung abscess	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Lung infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0011 affected562 at risk
Nasopharyngitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Neutropenic infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0009 affected548 at risk EG0015 affected562 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0009 affected548 at risk EG0015 affected562 at risk
Parotitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Peritonsillar abscess	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Pharyngitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Pneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG00019 affected548 at risk EG00113 affected562 at risk
Pneumonia necrotising	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Postoperative wound infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Pyothorax	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Respiratory tract infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0012 affected562 at risk
Sepsis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0009 affected548 at risk EG0013 affected562 at risk
Septic shock	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0006 affected548 at risk EG0010 affected562 at risk
Staphylococcal infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Urinary tract infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Wound infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Aspiration bronchial	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Blood creatinine increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected548 at risk EG0014 affected562 at risk
Blood glucose abnormal	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Blood potassium decreased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Blood urea increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
C-reactive protein increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Karnofsky scale worsened	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Neutrophil count decreased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Pulmonary arterial pressure increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Weight decreased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
White blood cell count decreased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0011 affected562 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected548 at risk EG0012 affected562 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG00012 affected548 at risk EG0019 affected562 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected548 at risk EG0010 affected562 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0011 affected562 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0011 affected562 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Metastases to heart	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Cerebral infarction	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected548 at risk EG0010 affected562 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0015 affected562 at risk
Cognitive disorder	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Coma	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Convulsion	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected548 at risk EG0010 affected562 at risk
Coordination abnormal	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Dizziness	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Dysarthria	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Epilepsy	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hemiparesis	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Hemiplegia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Horner's syndrome	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Monoparesis	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Nervous system disorder	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Neuralgia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Paraparesis	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Paraplegia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Somnolence	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Speech disorder	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Spinal cord compression	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Syncope	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0012 affected562 at risk
Syncope vasovagal	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Transverse sinus thrombosis	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Agitation	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Confusional state	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected548 at risk EG0014 affected562 at risk
Depression	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Hallucination	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Mental disorder	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Renal colic	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Renal failure	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0006 affected548 at risk EG0016 affected562 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Renal impairment	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0010 affected562 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00018 affected548 at risk EG00113 affected562 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected548 at risk EG0016 affected562 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0014 affected562 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0013 affected562 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00020 affected548 at risk EG00113 affected562 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0012 affected562 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0012 affected562 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00014 affected548 at risk EG0019 affected562 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 affected548 at risk EG0010 affected562 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Arterial occlusive disease	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Arterial thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Axillary vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0009 affected548 at risk EG0013 affected562 at risk
Embolism	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Haematoma	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Hypertensive crisis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0005 affected548 at risk EG0010 affected562 at risk
Iliac artery occlusion	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Phlebitis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0012 affected562 at risk
Shock	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Superior vena caval occlusion	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0012 affected562 at risk
Thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected548 at risk EG0012 affected562 at risk
Varicose vein	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Vascular fragility	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Vasculitis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected548 at risk EG0011 affected562 at risk
Venous thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0011 affected562 at risk
Visceral arterial ischaemia	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected548 at risk EG0010 affected562 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG000302 affected548 at risk EG001324 affected562 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG000226 affected548 at risk EG001264 affected562 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG000176 affected548 at risk EG001155 affected562 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00036 affected548 at risk EG00132 affected562 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00023 affected548 at risk EG00130 affected562 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (Unspecified)	Systematic Assessment	EG00049 affected548 at risk EG00155 affected562 at risk
Conjunctivitis	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG00033 affected548 at risk EG0016 affected562 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG000291 affected548 at risk EG001303 affected562 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG000214 affected548 at risk EG001225 affected562 at risk
Constipation	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG000204 affected548 at risk EG001189 affected562 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG000126 affected548 at risk EG001103 affected562 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00085 affected548 at risk EG00127 affected562 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00072 affected548 at risk EG00172 affected562 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00068 affected548 at risk EG00155 affected562 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00045 affected548 at risk EG00137 affected562 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00031 affected548 at risk EG0017 affected562 at risk
Fatigue	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG000202 affected548 at risk EG001181 affected562 at risk
Pyrexia	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG000112 affected548 at risk EG00180 affected562 at risk
Asthenia	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00090 affected548 at risk EG00196 affected562 at risk
Chest pain	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00070 affected548 at risk EG00170 affected562 at risk
Mucosal inflammation	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00056 affected548 at risk EG00123 affected562 at risk
Chills	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00035 affected548 at risk EG00119 affected562 at risk
Injection site reaction	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00033 affected548 at risk EG00129 affected562 at risk
Oedema peripheral	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00029 affected548 at risk EG00139 affected562 at risk
Paronychia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG00046 affected548 at risk EG0010 affected562 at risk
Nasopharyngitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG00037 affected548 at risk EG00116 affected562 at risk
Weight decreased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG00075 affected548 at risk EG00150 affected562 at risk
Blood creatinine increased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG00047 affected548 at risk EG00149 affected562 at risk
White blood cell count decreased	Investigations	MedDRA (Unspecified)	Systematic Assessment	EG00036 affected548 at risk EG00126 affected562 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG000208 affected548 at risk EG001202 affected562 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG00075 affected548 at risk EG00149 affected562 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG00054 affected548 at risk EG00127 affected562 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG00031 affected548 at risk EG00110 affected562 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00053 affected548 at risk EG00132 affected562 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00039 affected548 at risk EG00144 affected562 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00039 affected548 at risk EG00137 affected562 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00030 affected548 at risk EG00122 affected562 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00029 affected548 at risk EG00128 affected562 at risk
Dizziness	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00082 affected548 at risk EG00157 affected562 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00079 affected548 at risk EG00160 affected562 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00049 affected548 at risk EG00146 affected562 at risk
Paraesthesia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00040 affected548 at risk EG00127 affected562 at risk
Dysgeusia	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG00031 affected548 at risk EG00133 affected562 at risk
Insomnia	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG00058 affected548 at risk EG00149 affected562 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG000101 affected548 at risk EG00195 affected562 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00097 affected548 at risk EG00180 affected562 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00045 affected548 at risk EG00124 affected562 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00033 affected548 at risk EG00114 affected562 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00031 affected548 at risk EG00120 affected562 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00030 affected548 at risk EG00115 affected562 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG000249 affected548 at risk EG00117 affected562 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG000107 affected548 at risk EG001107 affected562 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00076 affected548 at risk EG0019 affected562 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00075 affected548 at risk EG0011 affected562 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00064 affected548 at risk EG00113 affected562 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00038 affected548 at risk EG0012 affected562 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00030 affected548 at risk EG0010 affected562 at risk
Phlebitis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG00048 affected548 at risk EG00144 affected562 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG00040 affected548 at risk EG00127 affected562 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG00039 affected548 at risk EG00123 affected562 at risk

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases