A Study of Atezolizumab in Combination With Bevacizumab i... | NCT04426825

Label	Type	Description	Intervention Names
Atezolizumab plus Bevacizumab	Experimental	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.	Drug: Atezolizumab Drug: Bevacizumab

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab	Drug	Atezolizumab will be administered at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle.	Atezolizumab plus Bevacizumab

Measure	Description	Time Frame
Objective Response Rate (ORR)	Objective response rate (ORR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).	Baseline up to approximately 10 months

Measure	Description	Time Frame
Duration of Objective Response (DOR)	Duration of objective response (DOR) was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.	Baseline up to approximately 2.5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Life expectancy ≥ 10 months
Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous.
No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions:

Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible.

Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible.

Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible.

TKIs approved for treatment of NSCLC discontinued >7 days prior to enrollment.
Measurable disease per RECIST v1.1. PD-L1 expression of ≥1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
ECOG Performance Status of 0-1
Adequate hematologic and end-organ function
Negative HIV test at screening
Negative hepatitis B surface antigen (HBsAg) test at screening
Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclusion Criteria:

Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
History of leptomeningeal disease
Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Active tuberculosis
Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Prior allogeneic stem cell or solid organ transplantation
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
Current treatment with anti-viral therapy for HBV
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab or bevacizumab formulations
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 6 months after the final dose of bevacizumab
Prior history of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease within 6 months prior to initiation of study treatment
History of Grade ≥ 2 hemoptysis within 1 month prior to enrollment
Evidence of bleeding diathesis or coagulopathy. Current or recent use of aspirin, clopidogrel or treatment with dipyramidole, ticlopidine, or cilostazol
Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for > 2 weeks prior to enrollment
History of stroke or transient ischemic attack within 6 months prior to enrollment
Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab
History of abdominal or tracheosphageal fistula or gastrointestinal perforation within 6 months prior to enrollment
History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis,or colitis
Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Proteinuria
Clear tumor infiltration into the thoracic great vessels is seen on imaging
Clear cavitation of pulmonary lesions is seen on imaging

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital		Beijing		100142	China
Beijing Hospital; Internal Medicine-Oncology

PubMed Identifier	Type	Citation	Retractions
41388935	Derived	Fang W, Fang J, Tian P, Fan Y, Yu Q, Zhang X, Wang Z, Liu X, Shi Y, Zhang L. Efficacy and Safety of Atezolizumab Plus Bevacizumab in Patients With Advanced NSCLC Who Received Pretreatment With EGFR-TKIs (ML41256): A Multicenter, Prospective, Single-Arm, Phase 2 Trial. Cancer Med. 2025 Dec;14(24):e71469. doi: 10.1002/cam4.71469.

ID	Title	Description
FG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 11, 2021	Jan 6, 2023

ID	Title	Description
BG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	BG00023

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

Objective Response Rate (ORR)

Objective response rate (ORR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

The evaluable population included all enrolled participants who received any amount of study treatment, had baseline and at least one post-baseline efficacy measurement.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline up to approximately 10 months

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG00022

Title

Denominators

Categories

Title	Measurements
	OG00018.2(5.19 to 40.28)

Secondary

Duration of Objective Response (DOR)

Duration of objective response (DOR) was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to RECIST v1.1.

The full analysis set (FAS) population included all enrolled participants who received any amount of at least one dose of any study treatment. The analysis population for this outcome measures included participants with a confirmed response (CR or PR).

Posted

Median

95% Confidence Interval

Months

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Time to Response (TTR)

Time to response (TTR) was defined as the time from the start of the treatment to the first objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST v1.1.

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment. The analysis population for this outcome measures included participants with a confirmed response (CR or PR).

Posted

Mean

Standard Deviation

Months

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Disease Control Rate (DCR)

Disease control rate (DCR) was defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

OS after enrollment was defined as the time from enrollment to death from any cause.

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Median

95% Confidence Interval

Months

Baseline until death due to any cause (up to approximately 2.5 years)

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Progression-Free Survival (PFS)

Progression-free survival (PFS) was defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Median

95% Confidence Interval

Months

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

PFS Rate at 6 and 12 Months

PFS rate at 6 and 12 months is defined as the percentage of participants who have not experienced disease progression or death from any cause at 6 and 12 months, as determined by the investigator according to RECIST v1.1.

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to 6 months and 12 months

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

OS Rate at 1 and 2 Years

OS rate at 1 and 2 years was defined as the percentage of participants who have not experienced death from any cause at 1 and 2 years.

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline to 1 and 2 Years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Adverse Events

Percentage of participants with adverse events.

The safety population is defined as all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Count of Participants

Participants

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Serious and Non-Serious Immune-Mediated Adverse Events (irAEs)

Percentage of serious and non-serious immune-mediated adverse events related to atezolizumab treatment. The AESIs were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria. The grading is as follows: Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE, Grade 5=Death related to AE.

The safety population is defined as all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Count of Participants

Participants

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Objective Response Rate (ORR) According to iRECIST

Objective response rate (ORR) is defined as the proportion of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Modified RECIST v1.1 (iRECIST).

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Disease Control Rate (DCR) According to iRECIST

Disease control rate (DCR) is defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to modified RECIST v1.1 (iRECIST).

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline up to 2 years and approximately 5 months

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Duration of Objective Response (DOR) According to iRECIST

Duration of objective response (DOR) is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).

Posted

Median

95% Confidence Interval

Months

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Progression-Free Survival (PFS) According to iRECIST

Progression-free survival (PFS) is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator according to modified RECIST v1.1 (iRECIST).

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Median

95% Confidence Interval

Months

Baseline up to approximately 2.5 years

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Progression-Free Survival (PFS) Rate at 12 Months According to iRECIST

Progression-free survival (PFS) rate is defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first at 12 months, as determined by the investigator according to modified RECIST v1.1 (iRECIST).

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment.

Posted

Median

95% Confidence Interval

Months

Baseline up to approximately 12 months

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants	OG000

Secondary

Time to Deterioation (TTD) Using EORTC

Time to deterioration (TTD) using European Organization for Research and treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ C30) and its Lung Cancer Module (QLQ LC13) is defined as the time from baseline to the first time the patient's score shows a >=10 points increase above baseline in any of the following EORTC-transformed symptom subscale scores (whichever occurs first): cough, dyspnoea (single item), dyspnoea (multi-item subscale), chest pain, or arm/shoulder pain, whichever occurred first. Scores ranged from 0-10. A higher score represented more severe symptoms.

Posted

Median

95% Confidence Interval

Months

Baselsine up to approximately 1 year

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts
Participants

Secondary

Change From Baseline in Health-Related Quality of Life (HRQoL) and Health Status

The 30-item EORTC QLQ-C30 version 3 is composed by five multi-item function scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), six single-item symptom scales (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), and a two-item global quality of life scale. All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for the functional and general health areas represent better functional status and quality of life. Higher scores for the symptom scales represent more symptoms or problems (poor quality of life). A participant was classified as improved if a decrement of 10 points or worse was observed in the change from baseline scores. A participant was classified as worsened if a 10-point or greater increase was observed in the change from baseline scores.

The FAS population included all enrolled participants who received any amount of at least one dose of any study treatment. The number of participants in the FAS with a non-missing baseline PRO assessment are presented. As each participant had different treatment cycles, this resulted in different numbers of participants analyzed per cycle.

Posted

Mean

Standard Deviation

Units on a scale

Baseline up to approximately 1 year

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Secondary

Change From Baseline in Lung Cancer Related Symptoms

The EORTC QLQ-LC13 is a specific module for lung cancer. It consists of 13 items covering lung cancer symptoms (dyspnoea, coughing, hemoptysis, pain in chest, pain in arm or shoulder and pain in other parts) and the side effects of chemo- and radiotherapy (alopecia, peripheral neuropathy, sore mouth, and dysphagia), which are divided into 10 fields, all are symptom types. All EORTC symptom scores are linearly transformed so that each score has a range of 0-100. A participant was classified as improved if a decrement of 10 points or worse was observed in the change from baseline scores. A participant was classified as worsened if a 10-point or greater increase was observed in the change from baseline scores.

Posted

Mean

Standard Deviation

Units on a scale

Baseline up to approximately 1 year

ID	Title	Description
OG000	Atezolizumab Plus Bevacizumab	Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0007 events5 affected23 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk
Hypothyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected23 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected23 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected23 at risk
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0006 events6 affected23 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected23 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0007 events5 affected23 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0005 events4 affected23 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG00010 events6 affected23 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0005 events5 affected23 at risk
Platelet count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG00010 events5 affected23 at risk
Blood bilirubin increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk
Urinary occult blood positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0005 events5 affected23 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0006 events5 affected23 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG00010 events5 affected23 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0006 events3 affected23 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0004 events3 affected23 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0003 events2 affected23 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 events2 affected23 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected23 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0005 events5 affected23 at risk
Proteinuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG00010 events7 affected23 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected23 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected23 at risk
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0007 events6 affected23 at risk
Weight decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0005 events5 affected23 at risk
Thyroxine free decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk
White blood cells urine positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected23 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected23 at risk
Malaise	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected23 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected23 at risk
Gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected23 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected23 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected23 at risk
Platelet count decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected23 at risk