Effectiveness Study of Nivolumab Compared to Chemotherapy... | NCT02481830

NCT02481830

ID	Type	Description	Link
2015-001097-18	EudraCT Number

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight 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
Arm A Nivolumab	Experimental	Nivolumab intravenous infusion as specified	Drug: Nivolumab
Arm B Chemotherapy Topotecan	Active Comparator	Topotecan as specified	Drug: Topotecan
Arm B Chemotherapy Amrubicin	Active Comparator	Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)	Drug: Amrubicin

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug		Arm A Nivolumab
Topotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.	OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months

Secondary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from randomization to the date of the first documented tumor progression based on investigator assessment (per RECIST 1.1), or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy. Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0065		Little Rock	Arkansas	72205	United States
Local Institution - 0024

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group A	Nivolumab 240mg IV on Day 1 of a 14-day cycle
FG001	Group B	Chemotherapy (Topotecan 1.5 mg/m^2 IV or 2.3 mg/m^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m^2 IV once daily on Days 1 to 3 of a 21-day cycle)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 20, 2018	Jul 19, 2023

Arm/Group Information

ID	Title	Description
BG000	Group A	Nivolumab 240mg IV on Day 1 of a 14-day cycle
BG001	Group B	Chemotherapy (Topotecan 1.5 mg/m^2 IV or 2.3 mg/m^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m^2 IV once daily on Days 1 to 3 of a 21-day cycle)
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

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00061.5± 9.2 BG00161.6± 8.4 BG00261.6± 8.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000110 BG001108 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0016 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival (OS)

The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.

All Randomized Participants

Posted

Median

95% Confidence Interval

Months

OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months

ID	Title	Description
OG000	Group A	Nivolumab 240mg IV on Day 1 of a 14-day cycle
OG001	Group B	Chemotherapy (Topotecan 1.5 mg/m^2 IV or 2.3 mg/m^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m^2 IV once daily on Days 1 to 3 of a 21-day cycle)

Units	Counts
Participants	OG000284 OG001285

Title

Denominators

Categories

Title	Measurements
	OG0007.46(5.65 to 9.20) OG0018.38(7.03 to 10.02)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.1144		Hazard Ratio (HR)	0.86			2-Sided	95	0.72	1.04			Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin		Superiority

Secondary

Progression Free Survival (PFS)

PFS is defined as the time from randomization to the date of the first documented tumor progression based on investigator assessment (per RECIST 1.1), or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to initiation of the subsequent anti-cancer therapy.

Progressive disease (PD)= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5 mm.

All Randomized Participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months)

ID	Title	Description
OG000	Group A	Nivolumab 240mg IV on Day 1 of a 14-day cycle
OG001	Group B	Chemotherapy (Topotecan 1.5 mg/m^2 IV or 2.3 mg/m^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m^2 IV once daily on Days 1 to 3 of a 21-day cycle)

Secondary

Objective Response Rate (ORR)

ORR is defined as the percentage of randomized participants whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) based on investigator assessment per RECIST 1.1 criteria. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For participants who continue nivolumab beyond progression, the BOR should be determined based on tumor assessments before initial RECIST 1.1 defined progression.

CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.

PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

All Randomized Participants

Posted

Number

95% Confidence Interval

Percentage of Participants

From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months)

ID	Title	Description
OG000	Group A	Nivolumab 240mg IV on Day 1 of a 14-day cycle
OG001	Group B	Chemotherapy (Topotecan 1.5 mg/m^2 IV or 2.3 mg/m^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m^2 IV once daily on Days 1 to 3 of a 21-day cycle)

Post-Hoc

Overall Survival (OS) - Extended Collection

The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.

All Randomized Participants

Posted

Median

95% Confidence Interval

Months

OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 64 months (Up to approximately 80 months)

ID	Title	Description
OG000	Group A	Nivolumab 240mg IV on Day 1 of a 14-day cycle
OG001	Group B	Chemotherapy (Topotecan 1.5 mg/m^2 IV or 2.3 mg/m^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m^2 IV once daily on Days 1 to 3 of a 21-day cycle)

Units	Counts
Participants	OG000

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	Group A	Nivolumab 240mg IV on Day 1 of a 14-day cycle	251	284	183	282	249	282
EG001	Group B	Chemotherapy (Topotecan 1.5 mg/m^2 IV or 2.3 mg/m^2 oral once daily on Days 1 to 5 of a 21-day cycle / Amrubicin 40 mg/m^2 IV once daily on Days 1 to 3 of a 21-day cycle)	256	285	171	265	248	265

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0003 affected282 at risk EG00114 affected265 at risk
Bone marrow failure	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Febrile neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0007 affected282 at risk EG00123 affected265 at risk
Leukopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0013 affected265 at risk
Lymphadenopathy	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Myelosuppression	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG00110 affected265 at risk
Neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG00111 affected265 at risk
Pancytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0018 affected265 at risk
Thrombocytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG00115 affected265 at risk
Acute myocardial infarction	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Atrial fibrillation	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0011 affected265 at risk
Atrial flutter	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Cardiac arrest	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Cardiac failure	Cardiac disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0011 affected265 at risk
Cardiac failure acute	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Cardiac tamponade	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Cardio-respiratory arrest	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Pericardial effusion	Cardiac disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Vertigo	Ear and labyrinth disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Cushing's syndrome	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Hyperthyroidism	Endocrine disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0010 affected265 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0012 affected265 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG0004 affected282 at risk EG0014 affected265 at risk
Abdominal pain upper	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Ascites	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0011 affected265 at risk
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0004 affected282 at risk EG0011 affected265 at risk
Duodenal ulcer	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Dysphagia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Gastric haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Gastritis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Intestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0012 affected265 at risk
Oral disorder	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0011 affected265 at risk
Asthenia	General disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0015 affected265 at risk
Chest pain	General disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Death	General disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Fatigue	General disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
General physical health deterioration	General disorders	25.0	Systematic Assessment	EG0008 affected282 at risk EG0016 affected265 at risk
Malaise	General disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0011 affected265 at risk
Mucosal inflammation	General disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Multiple organ dysfunction syndrome	General disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Non-cardiac chest pain	General disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0011 affected265 at risk
Oedema peripheral	General disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Pain	General disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0012 affected265 at risk
Performance status decreased	General disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Pyrexia	General disorders	25.0	Systematic Assessment	EG0004 affected282 at risk EG0013 affected265 at risk
Sudden death	General disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Drug-induced liver injury	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Hepatic failure	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Jaundice cholestatic	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Appendicitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Bacteraemia	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Bronchitis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected282 at risk EG0010 affected265 at risk
Bronchitis bacterial	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Bullous erysipelas	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Cellulitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Chronic sinusitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Device related infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Encephalitis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Enterocolitis infectious	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Erysipelas	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Herpes simplex	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Infectious pleural effusion	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Localised infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Neutropenic sepsis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0014 affected265 at risk
Ophthalmic herpes zoster	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Peritonsillar abscess	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG00015 affected282 at risk EG0019 affected265 at risk
Pneumonia aspiration	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Pneumonia bacterial	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Post procedural infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Pulmonary sepsis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0003 affected282 at risk EG0012 affected265 at risk
Sepsis	Infections and infestations	25.0	Systematic Assessment	EG0002 affected282 at risk EG0012 affected265 at risk
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG0002 affected282 at risk EG0011 affected265 at risk
Vascular device infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0012 affected265 at risk
Bone contusion	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Contusion	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected282 at risk EG0011 affected265 at risk
Infusion related reaction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected282 at risk EG0011 affected265 at risk
Injection related reaction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Subdural haematoma	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Synovial rupture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Amylase increased	Investigations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Blood creatinine increased	Investigations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Blood electrolytes abnormal	Investigations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
C-reactive protein increased	Investigations	25.0	Systematic Assessment	EG0000 affected282 at risk EG0012 affected265 at risk
Gamma-glutamyltransferase increased	Investigations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Lipase increased	Investigations	25.0	Systematic Assessment	EG0002 affected282 at risk EG0010 affected265 at risk
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG0002 affected282 at risk EG0014 affected265 at risk
Platelet count decreased	Investigations	25.0	Systematic Assessment	EG0004 affected282 at risk EG00110 affected265 at risk
White blood cell count decreased	Investigations	25.0	Systematic Assessment	EG0001 affected282 at risk EG0012 affected265 at risk
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0010 affected265 at risk
Hyperkalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0005 affected282 at risk EG0013 affected265 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0012 affected265 at risk
Arthritis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0011 affected265 at risk
Bone pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0010 affected265 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Epiglottic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG000108 affected282 at risk EG00185 affected265 at risk
Pericardial effusion malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Second primary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Tongue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Tumour invasion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Brain oedema	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Cerebellar ataxia	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Cerebrovascular accident	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0012 affected265 at risk
Epilepsy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Haemorrhage intracranial	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Headache	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0011 affected265 at risk
Hemiparesis	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Lacunar infarction	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Neurological symptom	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Paraneoplastic neurological syndrome	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Seizure	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Spinal cord compression	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Syncope	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Toxic encephalopathy	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Confusional state	Psychiatric disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0012 affected265 at risk
Delirium	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Disorientation	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Bladder dilatation	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Haematuria	Renal and urinary disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Renal failure	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0012 affected265 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0012 affected265 at risk
Cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0009 affected282 at risk EG0018 affected265 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0013 affected265 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0010 affected265 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Mediastinal disorder	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Oesophagobronchial fistula	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0012 affected265 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00010 affected282 at risk EG0010 affected265 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0011 affected265 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0014 affected265 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG0012 affected265 at risk
Dermatitis	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Paraneoplastic pemphigus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Pruritus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Deep vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0001 affected282 at risk EG0010 affected265 at risk
Poor venous access	Vascular disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Shock	Vascular disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0011 affected265 at risk
Superior vena cava syndrome	Vascular disorders	25.0	Systematic Assessment	EG0000 affected282 at risk EG0012 affected265 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG00068 affected282 at risk EG001163 affected265 at risk
Leukopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG00012 affected282 at risk EG00141 affected265 at risk
Neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG00017 affected282 at risk EG00193 affected265 at risk
Thrombocytopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG00019 affected282 at risk EG00178 affected265 at risk
Hypothyroidism	Endocrine disorders	25.0	Systematic Assessment	EG00023 affected282 at risk EG0011 affected265 at risk
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG00019 affected282 at risk EG00114 affected265 at risk
Abdominal pain upper	Gastrointestinal disorders	25.0	Systematic Assessment	EG00016 affected282 at risk EG00111 affected265 at risk
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG00045 affected282 at risk EG00149 affected265 at risk
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG00034 affected282 at risk EG00144 affected265 at risk
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG00048 affected282 at risk EG00159 affected265 at risk
Stomatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG00012 affected282 at risk EG00117 affected265 at risk
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG00033 affected282 at risk EG00141 affected265 at risk
Asthenia	General disorders	25.0	Systematic Assessment	EG00065 affected282 at risk EG00160 affected265 at risk
Fatigue	General disorders	25.0	Systematic Assessment	EG00063 affected282 at risk EG00178 affected265 at risk
Oedema peripheral	General disorders	25.0	Systematic Assessment	EG00012 affected282 at risk EG00117 affected265 at risk
Pyrexia	General disorders	25.0	Systematic Assessment	EG00028 affected282 at risk EG00137 affected265 at risk
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG00016 affected282 at risk EG00122 affected265 at risk
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG00015 affected282 at risk EG00113 affected265 at risk
Infusion related reaction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0008 affected282 at risk EG00116 affected265 at risk
Alanine aminotransferase increased	Investigations	25.0	Systematic Assessment	EG00022 affected282 at risk EG00113 affected265 at risk
Amylase increased	Investigations	25.0	Systematic Assessment	EG00015 affected282 at risk EG0012 affected265 at risk
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG00022 affected282 at risk EG00116 affected265 at risk
Blood alkaline phosphatase increased	Investigations	25.0	Systematic Assessment	EG00016 affected282 at risk EG0019 affected265 at risk
Gamma-glutamyltransferase increased	Investigations	25.0	Systematic Assessment	EG00020 affected282 at risk EG00111 affected265 at risk
Haemoglobin decreased	Investigations	25.0	Systematic Assessment	EG0005 affected282 at risk EG00114 affected265 at risk
Lipase increased	Investigations	25.0	Systematic Assessment	EG00027 affected282 at risk EG0014 affected265 at risk
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG00028 affected282 at risk EG00160 affected265 at risk
Platelet count decreased	Investigations	25.0	Systematic Assessment	EG00020 affected282 at risk EG00163 affected265 at risk
Weight decreased	Investigations	25.0	Systematic Assessment	EG00026 affected282 at risk EG00116 affected265 at risk
White blood cell count decreased	Investigations	25.0	Systematic Assessment	EG00026 affected282 at risk EG00146 affected265 at risk
Decreased appetite	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00079 affected282 at risk EG00170 affected265 at risk
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00015 affected282 at risk EG0018 affected265 at risk
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00019 affected282 at risk EG00118 affected265 at risk
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00024 affected282 at risk EG00125 affected265 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00027 affected282 at risk EG00117 affected265 at risk
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00030 affected282 at risk EG00125 affected265 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG00016 affected282 at risk EG00111 affected265 at risk
Dizziness	Nervous system disorders	25.0	Systematic Assessment	EG00020 affected282 at risk EG00117 affected265 at risk
Headache	Nervous system disorders	25.0	Systematic Assessment	EG00030 affected282 at risk EG00121 affected265 at risk
Insomnia	Psychiatric disorders	25.0	Systematic Assessment	EG00023 affected282 at risk EG00117 affected265 at risk
Cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00063 affected282 at risk EG00152 affected265 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00063 affected282 at risk EG00145 affected265 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected282 at risk EG00115 affected265 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG00020 affected282 at risk EG0018 affected265 at risk
Alopecia	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0004 affected282 at risk EG00126 affected265 at risk
Pruritus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00027 affected282 at risk EG0014 affected265 at risk
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG00021 affected282 at risk EG00111 affected265 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
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases