Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Can... | NCT03117049

Status Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

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
ONO-4538 group	Experimental	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.	Drug: ONO-4538 Drug: Carboplatin Drug: Paclitaxel Drug: Bevacizumab
Placebo group	Placebo Comparator	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.	Drug: Carboplatin Drug: Paclitaxel Drug: Bevacizumab Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ONO-4538	Drug	360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.	ONO-4538 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC)	PFS (as assessed by the IRRC) will be calculated using the following formula : PFS (days) = "date when overall response is assessed as progressive disease (PD) or date of death (for any reason), whichever comes first" - "date of randomization" + 1. Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.	Approximately 32 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)		Approximately 32 months
Objective Response Rate (ORR [as Assessed by the IRRC])	ORR represents the proportion of subjects whose best overall response was assessed as complete response (CR) or partial response (PR). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.

Eligibility Module

Name	Affiliation	Role
Shigeru Takahashi	Ono Pharmaceutical Co., Ltd.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Aichi Clinical Site2		Nagoya	Aichi-ken		Japan
Aichi Clinical Site3

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41640231	Derived	Sugawara S, Lee JS, Kang JH, Kim HR, Inui N, Hida T, Lee KH, Yoshida T, Tanaka H, Yang CT, Inoue T, Nishio M, Goto Y, Tamura T, Yamamoto N, Yu CJ, Akamatsu H, Takahashi S, Nakagawa K. Plain language summary of TASUKI-52: A study looking at nivolumab plus platinum chemotherapy and bevacizumab as a combined treatment for people with advanced or recurrent nonsquamous non-small cell lung cancer (NSCLC). Future Oncol. 2026 Feb;22(4):399-416. doi: 10.1080/14796694.2026.2617855. Epub 2026 Feb 4.
41611341

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 17, 2019	Oct 21, 2021

Arm/Group Information

ID	Title	Description
BG000	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
BG001	Placebo Group	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
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
	BG00066(27 to 85) BG00166(33 to 83) BG00266(27 to 85)

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

<65 years

Title	Measurements
	BG000131 BG001111 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00070 BG00169 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Country

Count of Participants

Participants

Title

Denominators

Categories

Japan

Title	Measurements
	BG000188 BG001183 BG002

ECOG Performance Score

Interactive Web Response System source. Score 0 : Fully active, able to carry on all pre-disease performance without restriction, Score 1 : Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000129 BG001

Smoking status

Former smokers included anyone who had smoked even a small quantity of any tobacco and had stopped smoking at the time of screening. Current smokers are anyone who had a smoking habit of any tobacco regardless of smoking duration/quantity at the screening.

Count of Participants

Participants

Title

Denominators

Categories

Never

Title	Measurements
	BG00061 BG001

Staging (the UICC-TNM classification, 7th edition)

Stage IIIB:T4(Tumor of any size that invades the mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, or with separate tumor nodules in a different ipsilateral lobe) and N2(Metastasis in ipsilateral mediastinal and/or subcarinal lymph node(s)), or N3(Metastasis in contralateral mediastinal, contralateral hilar, ipsilateral or contralateral scalene, or supraclavicular lymph node(s)) with any T Stage IV:Distant metastasis

Count of Participants

Participants

Title

Denominators

Categories

Stage IIIB

Title	Measurements
	BG00015 BG001

Metastasis

Count of Participants

Participants

Title

Denominators

Categories

Bone

Title	Measurements
	BG00056 BG00183 BG002

PD-L1 expression levels

Interactive Web Response System source. There were five patients with indeterminate PD-L1 expression levels in both arms.

Count of Participants

Participants

Title

Denominators

Categories

<1% or indeterminate

Title	Measurements
	BG000120 BG001120

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

Progression Free Survival (PFS) as Assessed by the Independent Radiology Review Committee (IRRC)

PFS (as assessed by the IRRC) will be calculated using the following formula : PFS (days) = "date when overall response is assessed as progressive disease (PD) or date of death (for any reason), whichever comes first" - "date of randomization" + 1. Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.

Posted

Median

96.37% Confidence Interval

months

Approximately 32 months

ID	Title	Description
OG000	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
OG001	Placebo Group	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Units	Counts
Participants	OG000275 OG001275

Title

Denominators

Categories

Title	Measurements
	OG00012.1(9.8 to 14.0) OG0018.1(7.0 to 8.5)

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		Stratified log-rank test		<0.0001		Hazard Ratio (HR)	0.56			2-Sided	96.37	0.43	0.71					Superiority

Secondary

Overall Survival (OS)

Posted

Median

95% Confidence Interval

months

Approximately 32 months

ID	Title	Description
OG000	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
OG001	Placebo Group	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Units	Counts

Secondary

Objective Response Rate (ORR [as Assessed by the IRRC])

ORR represents the proportion of subjects whose best overall response was assessed as complete response (CR) or partial response (PR). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.

Posted

Number

95% Confidence Interval

percentage of participants

Approximately 32 months

ID	Title	Description
OG000	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
OG001	Placebo Group	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Secondary

Disease Control Rate (DCR [as Assessed by the IRRC])

DCR represents the proportion of subjects whose best overall response was assessed as CR, PR, or stable disease (SD). Please refer to the protocol, in this study, tumor response will be evaluated by CT, etc. according to the RECIST 1.1 criteria.

Posted

Number

95% Confidence Interval

percentage of participants

Approximately 32 months

ID	Title	Description
OG000	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
OG001	Placebo Group	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Secondary

Duration of Response (DOR [as Assessed by the IRRC])

The lower and upper limits of 95% CI for the median are censored value in the both groups.

Posted

Median

95% Confidence Interval

months

Approximately 32 months

ID	Title	Description
OG000	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
OG001	Placebo Group	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Secondary

Best Overall Response (BOR [as Assessed by the IRRC])

For best overall response to be assessed as stable disease in this study, at least one stable disease or better rather than progressive disease on or after day 43 should be obtained.

Posted

Count of Participants

Participants

Approximately 32 months

ID	Title	Description
OG000	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
OG001	Placebo Group	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

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	ONO-4538 Group	ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.	82	275	154	273	271	273
EG001	Placebo Group	Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.	93	275	118	275	274	275

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0011 affected275 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG00027 affected273 at risk EG00112 affected275 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0011 affected275 at risk
Splenic haemorrhage	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0010 affected275 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0012 affected275 at risk
Angina unstable	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pericardial effusion	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0011 affected275 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Hypopituitarism	Endocrine disorders	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG0010 affected275 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Anal fistula	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0008 affected273 at risk EG0011 affected275 at risk
Colitis microscopic	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0011 affected275 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0012 affected275 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0013 affected275 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pancreatic fistula	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0010 affected275 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Asthenia	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0013 affected275 at risk
Chest pain	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Death	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Fatigue	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Haemorrhagic cyst	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Malaise	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Pyrexia	General disorders	MedDRA Version 22.1	Systematic Assessment	EG00016 affected273 at risk EG0014 affected275 at risk
Sudden death	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0011 affected275 at risk
Biloma	Hepatobiliary disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0011 affected275 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG0011 affected275 at risk
Anaphylactic reaction	Immune system disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0011 affected275 at risk
Anal abscess	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Appendicitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0003 affected273 at risk EG0010 affected275 at risk
Bronchitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Device related infection	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Diverticulitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0010 affected275 at risk
Enteritis infectious	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Haematoma infection	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Infection	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0012 affected275 at risk
Infectious pleural effusion	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Large intestine infection	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Lung abscess	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Osteomyelitis acute	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Otitis media chronic	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pleural infection bacterial	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pneumonia	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG00021 affected273 at risk EG00115 affected275 at risk
Pneumonia bacterial	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0011 affected275 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Sepsis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0013 affected275 at risk
Septic shock	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Sinusitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Skin infection	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Tonsillitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Angiocardiogram	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Blood bilirubin increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Hepatic enzyme increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Neutrophil count decreased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0010 affected275 at risk
Platelet count decreased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Weight increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
White blood cell count decreased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0018 affected275 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0012 affected275 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Fulminant type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0011 affected275 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0010 affected275 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Small intestine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Ataxia	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Brain stem infarction	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Cerebral infarction	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0012 affected275 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0010 affected275 at risk
Dizziness	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Epilepsy	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Headache	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Ischaemic stroke	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0012 affected275 at risk
Polyneuropathy	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Postresuscitation encephalopathy	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Presyncope	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Seizure	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0011 affected275 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Anxiety	Psychiatric disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Psychotic disorder	Psychiatric disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0011 affected275 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0011 affected275 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0011 affected275 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0013 affected275 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0013 affected275 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0009 affected273 at risk EG0010 affected275 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0008 affected273 at risk EG0015 affected275 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0003 affected273 at risk EG0011 affected275 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG0010 affected275 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG0010 affected275 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0010 affected275 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0010 affected275 at risk
Embolism	Vascular disorders	MedDRA Version 22.1	Systematic Assessment	EG0003 affected273 at risk EG0012 affected275 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA Version 22.1	Systematic Assessment	EG0000 affected273 at risk EG0011 affected275 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG00088 affected273 at risk EG001102 affected275 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG00019 affected273 at risk EG00115 affected275 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG00026 affected273 at risk EG00119 affected275 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG00052 affected273 at risk EG00138 affected275 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 22.1	Systematic Assessment	EG00017 affected273 at risk EG00121 affected275 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0017 affected275 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA Version 22.1	Systematic Assessment	EG0009 affected273 at risk EG0015 affected275 at risk
Hyperthyroidism	Endocrine disorders	MedDRA Version 22.1	Systematic Assessment	EG00015 affected273 at risk EG0014 affected275 at risk
Hypothyroidism	Endocrine disorders	MedDRA Version 22.1	Systematic Assessment	EG00027 affected273 at risk EG0018 affected275 at risk
Cataract	Eye disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0016 affected275 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0014 affected275 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0009 affected273 at risk EG00111 affected275 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00013 affected273 at risk EG0018 affected275 at risk
Cheilitis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0012 affected275 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG000150 affected273 at risk EG001134 affected275 at risk
Dental caries	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00012 affected273 at risk EG0012 affected275 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00081 affected273 at risk EG00166 affected275 at risk
Dry mouth	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0011 affected275 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00014 affected273 at risk EG00113 affected275 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0008 affected273 at risk EG0013 affected275 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0018 affected275 at risk
Gingival pain	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0008 affected273 at risk EG0011 affected275 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0016 affected275 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG00110 affected275 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00086 affected273 at risk EG001100 affected275 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0018 affected275 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00060 affected273 at risk EG00159 affected275 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00032 affected273 at risk EG00128 affected275 at risk
Asthenia	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0008 affected273 at risk EG00113 affected275 at risk
Fatigue	General disorders	MedDRA Version 22.1	Systematic Assessment	EG00024 affected273 at risk EG00131 affected275 at risk
Infusion site extravasation	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0009 affected273 at risk EG0017 affected275 at risk
Malaise	General disorders	MedDRA Version 22.1	Systematic Assessment	EG00072 affected273 at risk EG00178 affected275 at risk
Oedema peripheral	General disorders	MedDRA Version 22.1	Systematic Assessment	EG00016 affected273 at risk EG00113 affected275 at risk
Pain	General disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0015 affected275 at risk
Pyrexia	General disorders	MedDRA Version 22.1	Systematic Assessment	EG00064 affected273 at risk EG00141 affected275 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Version 22.1	Systematic Assessment	EG00020 affected273 at risk EG0019 affected275 at risk
Bronchitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0009 affected273 at risk EG0018 affected275 at risk
Conjunctivitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0016 affected275 at risk
Gingivitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0019 affected275 at risk
Herpes zoster	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0017 affected275 at risk
Influenza	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0014 affected275 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG00022 affected273 at risk EG00119 affected275 at risk
Paronychia	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0003 affected273 at risk EG0017 affected275 at risk
Periodontitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG00012 affected273 at risk EG0017 affected275 at risk
Pharyngitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG00013 affected273 at risk EG0019 affected275 at risk
Pneumonia	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG00017 affected273 at risk EG00113 affected275 at risk
Rhinitis	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0016 affected275 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG00024 affected273 at risk EG00118 affected275 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG00110 affected275 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA Version 22.1	Systematic Assessment	EG0009 affected273 at risk EG0016 affected275 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00033 affected273 at risk EG00135 affected275 at risk
Amylase increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00010 affected273 at risk EG0010 affected275 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00037 affected273 at risk EG00128 affected275 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00010 affected273 at risk EG00112 affected275 at risk
Blood bilirubin increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0018 affected275 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG00110 affected275 at risk
Blood creatinine increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00022 affected273 at risk EG00118 affected275 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00023 affected273 at risk EG00111 affected275 at risk
Lymphocyte count decreased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00015 affected273 at risk EG0019 affected275 at risk
Neutrophil count decreased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG000117 affected273 at risk EG001141 affected275 at risk
Platelet count decreased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00062 affected273 at risk EG00167 affected275 at risk
Weight decreased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00023 affected273 at risk EG00116 affected275 at risk
White blood cell count decreased	Investigations	MedDRA Version 22.1	Systematic Assessment	EG00094 affected273 at risk EG00199 affected275 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG00098 affected273 at risk EG001108 affected275 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG0018 affected275 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG00012 affected273 at risk EG0013 affected275 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG00013 affected273 at risk EG00114 affected275 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG00011 affected273 at risk EG00111 affected275 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG00018 affected273 at risk EG00115 affected275 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG00011 affected273 at risk EG00111 affected275 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 22.1	Systematic Assessment	EG00014 affected273 at risk EG00119 affected275 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00072 affected273 at risk EG00184 affected275 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0005 affected273 at risk EG0017 affected275 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00026 affected273 at risk EG00119 affected275 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0013 affected275 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG0016 affected275 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0017 affected275 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00011 affected273 at risk EG00110 affected275 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00076 affected273 at risk EG00192 affected275 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00010 affected273 at risk EG00116 affected275 at risk
Dizziness	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG00010 affected273 at risk EG00121 affected275 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG00033 affected273 at risk EG00120 affected275 at risk
Headache	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG00035 affected273 at risk EG00128 affected275 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG00010 affected273 at risk EG00112 affected275 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG00059 affected273 at risk EG00164 affected275 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG00015 affected273 at risk EG00118 affected275 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG000121 affected273 at risk EG001116 affected275 at risk
Somnolence	Nervous system disorders	MedDRA Version 22.1	Systematic Assessment	EG0001 affected273 at risk EG0017 affected275 at risk
Delirium	Psychiatric disorders	MedDRA Version 22.1	Systematic Assessment	EG0004 affected273 at risk EG0017 affected275 at risk
Insomnia	Psychiatric disorders	MedDRA Version 22.1	Systematic Assessment	EG00045 affected273 at risk EG00149 affected275 at risk
Dysuria	Renal and urinary disorders	MedDRA Version 22.1	Systematic Assessment	EG0002 affected273 at risk EG0016 affected275 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 22.1	Systematic Assessment	EG00067 affected273 at risk EG00174 affected275 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0011 affected275 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00021 affected273 at risk EG00134 affected275 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0008 affected273 at risk EG00113 affected275 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0009 affected273 at risk EG0017 affected275 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00051 affected273 at risk EG00148 affected275 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00011 affected273 at risk EG00112 affected275 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00045 affected273 at risk EG00136 affected275 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00014 affected273 at risk EG00113 affected275 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0016 affected275 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG00013 affected273 at risk EG00111 affected275 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG00116 affected275 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG000143 affected273 at risk EG001150 affected275 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00023 affected273 at risk EG00117 affected275 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0011 affected275 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00032 affected273 at risk EG00124 affected275 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG0006 affected273 at risk EG0013 affected275 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00061 affected273 at risk EG00148 affected275 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00096 affected273 at risk EG00148 affected275 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00029 affected273 at risk EG00114 affected275 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 22.1	Systematic Assessment	EG00016 affected273 at risk EG0017 affected275 at risk
Hypertension	Vascular disorders	MedDRA Version 22.1	Systematic Assessment	EG00074 affected273 at risk EG00189 affected275 at risk
Hypotension	Vascular disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG0019 affected275 at risk
Vasculitis	Vascular disorders	MedDRA Version 22.1	Systematic Assessment	EG0007 affected273 at risk EG00111 affected275 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
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

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
D000077594	Nivolumab
D016190	Carboplatin
D017239	Paclitaxel
D000068258	Bevacizumab