A Study of Bevacizumab in Combination With Standard of Ca... | NCT01351415

ID	Type	Description	Link
2010-022645-14	EudraCT Number

Label	Type	Description	Intervention Names
Bevacizumab + Standard of Care	Experimental	Participants will receive bevacizumab on Day 1 of every 21-days cycle along with standard of care (Erlotinib or Docetaxel or Pemetrexed) as second line treatment, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).	Drug: Bevacizumab Drug: Docetaxel Drug: Erlotinib Drug: Pemetrexed
Standard of Care	Active Comparator	Participants will receive investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).	Drug: Docetaxel Drug: Erlotinib Drug: Pemetrexed

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.	Bevacizumab + Standard of Care

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival (OS) was defined as the time from the date of randomization at first progression of disease to the date of death, regardless of the cause of death.	Up to data cut-off date 24 June 2016 (approximately 5 years)

Measure	Description	Time Frame
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS2 is defined as the time between randomization at PD1 and the date of PD2 or death, whichever occurs first. PFS3 is defined as the time between PD2 and the date of PD3 or death, whichever occurs first.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed non-squamous NSCLC
Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4-6 cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
No treatment interruption of Bevacizumab treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
Randomization within 4 weeks of progression of disease
At least one unidimensionally measurable lesion meeting RECIST v1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Participants with adequate hematological, liver, and renal function
Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)

Exclusion Criteria:

Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local laboratory testing
History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of randomization
History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding
Major cardiac disease
Treatment with any other investigational agent within 28 days prior to randomization
Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs foreseen
Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
USA Mitchell Cancer Institute		Mobile	Alabama	36688	United States
Palo Verde Hema/Onc

PubMed Identifier	Type	Citation	Retractions
30177994	Derived	Gridelli C, de Castro Carpeno J, Dingemans AC, Griesinger F, Grossi F, Langer C, Ohe Y, Syrigos K, Thatcher N, Das-Gupta A, Truman M, Donica M, Smoljanovic V, Bennouna J. Safety and Efficacy of Bevacizumab Plus Standard-of-Care Treatment Beyond Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer: The AvaALL Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e183486. doi: 10.1001/jamaoncol.2018.3486. Epub 2018 Dec 13.
26828788

ID	Title	Description
FG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
FG001	Standard of Care

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 (OS)

Overall survival (OS) was defined as the time from the date of randomization at first progression of disease to the date of death, regardless of the cause of death.

Intent to treat population included all randomized participants.

Posted

Median

90% Confidence Interval

Months

Up to data cut-off date 24 June 2016 (approximately 5 years)

ID	Title	Description
OG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
OG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Units	Counts
Participants	OG000245 OG001240

Title

Denominators

Categories

Title	Measurements
	OG00011.86(10.22 to 13.67) OG00110.22(8.61 to 11.93)

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	The stratification factors for Log-Rank test and Hazard Ratio (HR) are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to first PD and smoking status.	Stratified Log-Rank test		0.1044		Stratified Hazard Ratio	0.84			2-Sided	90	0.71	1.00					Superiority or Other

Secondary

Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS2 is defined as the time between randomization at PD1 and the date of PD2 or death, whichever occurs first. PFS3 is defined as the time between PD2 and the date of PD3 or death, whichever occurs first.

Intent to treat population included all randomized participants.

Posted

Median

90% Confidence Interval

Months

Up to data cut-off date 24 June 2016 (approximately 5 years)

ID	Title	Description
OG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
OG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Secondary

Percentage of Participants With Objective Response According to RECIST v1.1

The objective response is defined as complete response (CR) or partial response (PR) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.

Intent to treat population included all randomized participants.

Posted

Number

90% Confidence Interval

Percentage of Participants

Up to data cut-off date 24 June 2016 (approximately 5 years)

ID	Title	Description
OG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
OG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Secondary

Percentage of Participants With Disease Control According to RECIST v1.1

The disease control rate is defined as CR or PR or stable disease (SD) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started for target lesions and the persistence of 1 or more non-target lesions.

Intent to treat population included all randomized participants.

Posted

Number

90% Confidence Interval

Percentage of Participants

Up to data cut-off date 24 June 2016 (approximately 5 years)

ID	Title	Description
OG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
OG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Secondary

Duration of Response (DoR) According to RECIST v1.1

Duration of response is defined as the time that measurement criteria are met for objective response (CR/PR) (whichever status is recorded first) until the first date of progression or death is documented. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than < 10 mm. PR was defined as greater than or equal to ≥30 % decrease in sum of longest diameter of target lesions in reference to baseline sum longest diameter.

Intent to treat population included all randomized participants.

Posted

Median

90% Confidence Interval

Months

Up to data cut-off date 24 June 2016 (approximately 5 years)

ID	Title	Description
OG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
OG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Secondary

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.

The safety population included all participants who had received at least one dose of any study drug.

Posted

Number

Percentage of Participants

Up to data cut-off date 24 June 2016 (approximately 5 years)

ID	Title	Description
OG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
OG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Secondary

Time to Progression (TTP) According to RECIST v1.1

The time to progression was defined as the time from baseline until disease progression as determined by the RECIST v1.1. TTP2 is defined as the interval between the day of randomization at PD1 and PD2. TTP3 is defined as the interval between the day of PD2 and PD3. PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Intent to treat population included all randomized participants.

Posted

Median

90% Confidence Interval

Months

Up to data cut-off date 24 June 2016 (approximately 5 years)

ID	Title	Description
OG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
OG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Secondary

Percentage of Participants Who Are Alive at Month 6, 12, and 18

Percentage of participants who were alive at Month 6, 12 and 18 were reported.

Intent to treat population included all randomized participants.

Posted

Number

90% Confidence Interval

Percentage of Participants

Month 6, 12, 18

ID	Title	Description
OG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
OG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0016 affected232 at risk
Bone Marrow Failure	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Febrile Bone Marrow Aplasia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00012 affected243 at risk EG0019 affected232 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected232 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0009 affected243 at risk EG0016 affected232 at risk
Pure White Cell Aplasia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected232 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected243 at risk EG0011 affected232 at risk
Cardiac Failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Cyanosis	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Aplasia	Congenital, familial and genetic disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Tracheo-oesophageal Fistula	Congenital, familial and genetic disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Adrenal Insufficiency	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected232 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Ascites	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0007 affected243 at risk EG0012 affected232 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Gastrointestinal Obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Inguinal Hernia Strangulated	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Mechanical Ileus	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Oesophageal Stenosis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected232 at risk
Pneumatosis Intestinalis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Small Intestinal Perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Subileus	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected232 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected243 at risk EG0010 affected232 at risk
Death	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected232 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected232 at risk
General Physical Health Deterioration	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected232 at risk
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Mucosal Inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected232 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Performance Status Decreased	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected243 at risk EG0011 affected232 at risk
Sudden Death	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Bile Duct Obstruction	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Liver Disorder	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Anal Abcess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Appendicitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Appendicitis Perforated	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Bronchopulmonary Aspergillosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Device related Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Diarrhoea Infectious	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Diverticulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Empyema	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Endocarditis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Febrile Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Genital Herpes Simplex	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Herpes Zoster	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Influenza	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Lung Abcess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Lung Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected232 at risk
Periorbital Abcess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00013 affected243 at risk EG00119 affected232 at risk
Post Procedural Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Psoas Abcess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0006 affected243 at risk EG0011 affected232 at risk
Respiratory tract Infection Bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected232 at risk
Septic Shock	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Subcutaneous Abcess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Tracheitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Alcohol Poisoning	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Arterial Injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Blood Bilirubin Increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Blood Creatinine Increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected232 at risk
Liver Function Test Increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Lymphocyte Count Decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
White Blood Cell Count Decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected232 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected243 at risk EG0011 affected232 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected232 at risk
Tetany	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected232 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Intervetebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected232 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected232 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Metastases to Adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0011 affected232 at risk
Epilepsy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Neuralgia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Parapalegia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Peripheral Motor Neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Posterior Reversible Encephalopathy Syndrome	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Seizure	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Apathy	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Confusional State	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0012 affected232 at risk
Delirium	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Disorientation	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected232 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Nephrotic Syndrome	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Prerenal Failure	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Renal Failure	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Renal Tubular Disorder	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Bronchial Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected243 at risk EG0010 affected232 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected243 at risk EG0013 affected232 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected232 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0012 affected232 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0013 affected232 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Organizing Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected243 at risk EG0014 affected232 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected232 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0005 affected243 at risk EG0016 affected232 at risk
Pulmonary Haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Pulmonary Thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected232 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0010 affected232 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Erythema Multiforme	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Skin Toxicity	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Osteosynthesis	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0010 affected232 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected243 at risk EG0011 affected232 at risk
Peripheral Embolism	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected243 at risk EG0011 affected232 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected243 at risk EG0012 affected232 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00054 affected243 at risk EG00169 affected232 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00016 affected243 at risk EG00110 affected232 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00039 affected243 at risk EG00120 affected232 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG00015 affected243 at risk EG0019 affected232 at risk
Lacrimation Increased	Eye disorders	MedDRA 19.0	Systematic Assessment	EG00018 affected243 at risk EG00112 affected232 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00016 affected243 at risk EG00113 affected232 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00025 affected243 at risk EG00114 affected232 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00064 affected243 at risk EG00149 affected232 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00090 affected243 at risk EG00172 affected232 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00084 affected243 at risk EG00161 affected232 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00039 affected243 at risk EG00126 affected232 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG00051 affected243 at risk EG00140 affected232 at risk
Asthenia	General disorders	MedDRA 19.0	Systematic Assessment	EG00068 affected243 at risk EG00161 affected232 at risk
Chest Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG00026 affected243 at risk EG00116 affected232 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG00071 affected243 at risk EG00173 affected232 at risk
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG00024 affected243 at risk EG00114 affected232 at risk
Mucosal Inflammation	General disorders	MedDRA 19.0	Systematic Assessment	EG00049 affected243 at risk EG00122 affected232 at risk
Oedema Peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG00034 affected243 at risk EG00132 affected232 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG00010 affected243 at risk EG00113 affected232 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG00046 affected243 at risk EG00135 affected232 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00023 affected243 at risk EG00112 affected232 at risk
Conjunctivitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00016 affected243 at risk EG00113 affected232 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0009 affected243 at risk EG00112 affected232 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00013 affected243 at risk EG0019 affected232 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00016 affected243 at risk EG00110 affected232 at risk
Blood Creatinine Increased	Investigations	MedDRA 19.0	Systematic Assessment	EG00013 affected243 at risk EG0014 affected232 at risk
Weight Decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG00042 affected243 at risk EG00124 affected232 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00083 affected243 at risk EG00159 affected232 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG00013 affected243 at risk EG0012 affected232 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00021 affected243 at risk EG00121 affected232 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00028 affected243 at risk EG00131 affected232 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00013 affected243 at risk EG0018 affected232 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00022 affected243 at risk EG00118 affected232 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00018 affected243 at risk EG00118 affected232 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00017 affected243 at risk EG00116 affected232 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00020 affected243 at risk EG00113 affected232 at risk
Dysgeusia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00029 affected243 at risk EG00116 affected232 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00039 affected243 at risk EG00123 affected232 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00020 affected243 at risk EG00116 affected232 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00015 affected243 at risk EG0018 affected232 at risk
Anxiety	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00011 affected243 at risk EG00112 affected232 at risk
Insomnia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG00014 affected243 at risk EG00115 affected232 at risk
Proteinuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG00051 affected243 at risk EG00123 affected232 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00039 affected243 at risk EG00140 affected232 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00013 affected243 at risk EG00113 affected232 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00056 affected243 at risk EG00156 affected232 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00053 affected243 at risk EG00120 affected232 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00017 affected243 at risk EG00111 affected232 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG00013 affected243 at risk EG00115 affected232 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00055 affected243 at risk EG00141 affected232 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00015 affected243 at risk EG0018 affected232 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00029 affected243 at risk EG00122 affected232 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00011 affected243 at risk EG00117 affected232 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00017 affected243 at risk EG00114 affected232 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG00049 affected243 at risk EG00146 affected232 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG00052 affected243 at risk EG00125 affected232 at risk

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000600	Amino Acids, Dicarboxylic

ID	Title	Description
BG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
BG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bevacizumab + Standard of Care	Participants received bevacizumab on Day 1 of every 21-days cycle along with standard of care, until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).			126	243	226	243
EG001	Standard of Care	Participants received investigator's choice of standard of care (Erlotinib or Docetaxel or Pemetrexed) according to local practice until the occurrence of an unacceptable toxicity or withdrawal of consent (whichever occurs first).			86	232	215	232

ID	Term
D000068258	Bevacizumab
D000077143	Docetaxel
D000069347	Erlotinib Hydrochloride
D000068437	Pemetrexed