A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivol... | NCT02998528

NCT02998528

ID	Type	Description	Link
2016-003536-21	EudraCT Number

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	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
Platinum doublet chemotherapy	Active Comparator	Specified dose on specified days	Drug: Cisplatin Drug: Vinorelbine Drug: Gemcitabine Drug: Docetaxel Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel
Nivolumab plus platinum doublet chemotherapy	Experimental	Specified dose on specified days	Biological: Nivolumab Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel
Nivolumab plus Ipilimumab	Experimental	Specified dose on specified days	Biological: Nivolumab Biological: Ipilimumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days	Nivolumab plus Ipilimumab Nivolumab plus platinum doublet chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event-Free Survival (EFS)	Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).	From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
Pathologic Complete Response (pCR) Rate	Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).	From randomization up to a median of 30 months after randomization.

Secondary Outcomes

Measure	Description	Time Frame
Major Pathologic Response (MPR) Rate	Major pathologic response (MPR) rate is defined as number of randomized participants with \	From randomization up to a median of 30 months after randomization.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0121		Glendale	Arizona	85308	United States
Local Institution - 0081

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40454642	Derived	Forde PM, Spicer JD, Provencio M, Mitsudomi T, Awad MM, Wang C, Lu S, Felip E, Swanson SJ, Brahmer JR, Kerr K, Taube JM, Ciuleanu TE, Tanaka F, Saylors GB, Chen KN, Ito H, Liberman M, Martin C, Broderick S, Wang L, Cai J, Duong Q, Meadows-Shropshire S, Fiore J, Bhatia S, Girard N; CheckMate 816 Investigators. Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer. N Engl J Med. 2025 Aug 21;393(8):741-752. doi: 10.1056/NEJMoa2502931. Epub 2025 Jun 2.
39778121

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg	Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes. Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

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	Aug 18, 2021	Aug 31, 2022

Arm/Group Information

ID	Title	Description
BG000	Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg	Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes. Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
BG001	Arm B: Platinum Doublet Chemo	Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
BG002	Arm C: Nivo 360 mg + Platinum Doublet Chemo	Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
BG003	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, Customized

Number

Participants

Title

Denominators

Categories

< 65

Title	Measurements
	BG00062 BG00199 BG00293 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00040 BG00165 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 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

Event-Free Survival (EFS)

Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

All concurrently randomized participants in Arm C and Arm B

Posted

Median

95% Confidence Interval

Months

From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)

ID	Title	Description
OG000	Arm B: Platinum Doublet Chemo	Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
OG001	Arm C: Nivo 360 mg + Platinum Doublet Chemo	Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

Units	Counts
Participants	OG000179 OG001179

Title

Denominators

Categories

Title	Measurements
	OG00020.80(14.03 to 26.71) OG00131.57(30.16 to NA)Insufficient number of participants with events

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	Stratified by PD-L1 (≥ 1% vs <1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)	0.0052		Cox Proportional Hazard	0.63			2-Sided	97.38	0.43	0.91					Superiority

Primary

Pathologic Complete Response (pCR) Rate

Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).

All concurrently randomized participants in Arm C and Arm B

Posted

Count of Participants

Participants

From randomization up to a median of 30 months after randomization.

ID	Title	Description
OG000	Arm B: Platinum Doublet Chemo	Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
OG001	Arm C: Nivo 360 mg + Platinum Doublet Chemo	Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

Post-Hoc

Event-Free Survival (EFS)

All concurrently randomized participants in Arm C and Arm B

Posted

Median

95% Confidence Interval

Months

From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 69 months)

ID	Title	Description
OG000	Arm B: Platinum Doublet Chemo	Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
OG001	Arm C: Nivo 360 mg + Platinum Doublet Chemo

Secondary

Major Pathologic Response (MPR) Rate

Major pathologic response (MPR) rate is defined as number of randomized participants with \

All concurrently randomized participants in Arm C and Arm B

Posted

Count of Participants

Participants

From randomization up to a median of 30 months after randomization.

ID	Title	Description
OG000	Arm B: Platinum Doublet Chemo	Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
OG001	Arm C: Nivo 360 mg + Platinum Doublet Chemo	Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

Secondary

Overall Survival (OS)

Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.

All concurrently randomized participants in Arm C and Arm B

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death (Up to approximately 93 months)

ID	Title	Description
OG000	Arm B: Platinum Doublet Chemo	Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
OG001	Arm C: Nivo 360 mg + Platinum Doublet Chemo	Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

Units

Secondary

Time to Death or Distant Metastases (TTDM)

TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.

All concurrently randomized participants in Arm C and Arm B

Posted

Median

95% Confidence Interval

Months

From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months)

ID	Title	Description
OG000	Arm B: Platinum Doublet Chemo	Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
OG001	Arm C: Nivo 360 mg + Platinum Doublet Chemo	Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

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	Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg	Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes. Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.	46	112	30	111	102	111
EG001	Arm B: Platinum Doublet Chemo	Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.	105	214	58	208	202	208
EG002	Arm C: Nivo 360 mg + Platinum Doublet Chemo	Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.	66	179	53	176	160	176

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Coagulopathy	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Febrile neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0016 affected208 at risk EG0023 affected176 at risk
Myelosuppression	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0012 affected208 at risk EG0020 affected176 at risk
Pancytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Arrhythmia	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Arteriosclerosis coronary artery	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Cardiac failure	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Cardiac ventricular thrombosis	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Myocardial infarction	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Myocardial ischaemia	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Myocarditis	Cardiac disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Stress cardiomyopathy	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Adrenal insufficiency	Endocrine disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Hypophysitis	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Ocular myasthenia	Eye disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Abdominal pain upper	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Colitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0002 affected111 at risk EG0012 affected208 at risk EG0020 affected176 at risk
Gastric ulcer	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Haematochezia	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Oesophageal perforation	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Small intestinal obstruction	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0024 affected176 at risk
Death	General disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
General physical health deterioration	General disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Malaise	General disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Drug-induced liver injury	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Hepatitis	Hepatobiliary disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Anaphylactic reaction	Immune system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Hypersensitivity	Immune system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Bacteraemia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Cellulitis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Empyema	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Enterocolitis infectious	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Gastroenteritis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Infectious pleural effusion	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Influenza	Infections and infestations	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Klebsiella bacteraemia	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Nasopharyngitis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Pleural infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0005 affected111 at risk EG0018 affected208 at risk EG0026 affected176 at risk
Pneumonia aspiration	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Pneumonia bacterial	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Pneumonia influenzal	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Post procedural infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Pyelonephritis acute	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Sepsis	Infections and infestations	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Septic shock	Infections and infestations	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Subcutaneous abscess	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Tuberculosis	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Urinary tract infection	Infections and infestations	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Wound infection	Infections and infestations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Cardiac function disturbance postoperative	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Overdose	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Post procedural complication	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected111 at risk EG0011 affected208 at risk EG0022 affected176 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Postoperative delirium	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0002 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Glycosylated haemoglobin increased	Investigations	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Hepatic enzyme abnormal	Investigations	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Transaminases increased	Investigations	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0012 affected208 at risk EG0020 affected176 at risk
Myositis	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0002 affected111 at risk EG0015 affected208 at risk EG0022 affected176 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Second primary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Tumour pseudoprogression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Carotid artery stenosis	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Cerebral infarction	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Encephalopathy	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Immune-mediated myasthenia gravis	Nervous system disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Ischaemic stroke	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Syncope	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Acute kidney injury	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0012 affected208 at risk EG0023 affected176 at risk
Prostatitis	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0012 affected208 at risk EG0020 affected176 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Lung opacity	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0004 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Pneumonitis aspiration	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0011 affected208 at risk EG0021 affected176 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0011 affected208 at risk EG0023 affected176 at risk
Pulmonary fistula	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0012 affected208 at risk EG0021 affected176 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG0010 affected208 at risk EG0020 affected176 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0022 affected176 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Aortic rupture	Vascular disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Arterial thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Deep vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Embolism	Vascular disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0022 affected176 at risk
Hypotension	Vascular disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Iliac artery occlusion	Vascular disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk
Subclavian vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0011 affected208 at risk EG0020 affected176 at risk
Superficial vein thrombosis	Vascular disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0010 affected208 at risk EG0021 affected176 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0009 affected111 at risk EG00178 affected208 at risk EG00262 affected176 at risk
Leukopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG00117 affected208 at risk EG00218 affected176 at risk
Neutropenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG00139 affected208 at risk EG00232 affected176 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG00117 affected208 at risk EG0025 affected176 at risk
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0018 affected208 at risk EG0029 affected176 at risk
Tinnitus	Ear and labyrinth disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG00117 affected208 at risk EG0026 affected176 at risk
Hyperthyroidism	Endocrine disorders	27.1	Systematic Assessment	EG0007 affected111 at risk EG0010 affected208 at risk EG0027 affected176 at risk
Hypothyroidism	Endocrine disorders	27.1	Systematic Assessment	EG00011 affected111 at risk EG0011 affected208 at risk EG0022 affected176 at risk
Constipation	Gastrointestinal disorders	27.1	Systematic Assessment	EG00024 affected111 at risk EG00173 affected208 at risk EG00263 affected176 at risk
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00018 affected111 at risk EG00134 affected208 at risk EG00221 affected176 at risk
Nausea	Gastrointestinal disorders	27.1	Systematic Assessment	EG00024 affected111 at risk EG001105 affected208 at risk EG00273 affected176 at risk
Stomatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0004 affected111 at risk EG00112 affected208 at risk EG0026 affected176 at risk
Vomiting	Gastrointestinal disorders	27.1	Systematic Assessment	EG00010 affected111 at risk EG00130 affected208 at risk EG00220 affected176 at risk
Asthenia	General disorders	27.1	Systematic Assessment	EG00013 affected111 at risk EG00127 affected208 at risk EG00219 affected176 at risk
Fatigue	General disorders	27.1	Systematic Assessment	EG00024 affected111 at risk EG00139 affected208 at risk EG00230 affected176 at risk
Malaise	General disorders	27.1	Systematic Assessment	EG0003 affected111 at risk EG00126 affected208 at risk EG00227 affected176 at risk
Non-cardiac chest pain	General disorders	27.1	Systematic Assessment	EG0004 affected111 at risk EG00112 affected208 at risk EG0027 affected176 at risk
Oedema peripheral	General disorders	27.1	Systematic Assessment	EG0004 affected111 at risk EG00111 affected208 at risk EG0026 affected176 at risk
Pain	General disorders	27.1	Systematic Assessment	EG0008 affected111 at risk EG00129 affected208 at risk EG00218 affected176 at risk
Pyrexia	General disorders	27.1	Systematic Assessment	EG00018 affected111 at risk EG00123 affected208 at risk EG00220 affected176 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0003 affected111 at risk EG00114 affected208 at risk EG00215 affected176 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG0004 affected111 at risk EG0018 affected208 at risk EG0029 affected176 at risk
Incision site pain	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG00010 affected111 at risk EG0016 affected208 at risk EG0023 affected176 at risk
Procedural pain	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG00012 affected111 at risk EG00112 affected208 at risk EG00217 affected176 at risk
Wound complication	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0004 affected111 at risk EG00115 affected208 at risk EG00214 affected176 at risk
Alanine aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0007 affected111 at risk EG00118 affected208 at risk EG00213 affected176 at risk
Aspartate aminotransferase increased	Investigations	27.1	Systematic Assessment	EG0003 affected111 at risk EG00114 affected208 at risk EG0024 affected176 at risk
Blood creatinine increased	Investigations	27.1	Systematic Assessment	EG0001 affected111 at risk EG00114 affected208 at risk EG00215 affected176 at risk
Neutrophil count decreased	Investigations	27.1	Systematic Assessment	EG0007 affected111 at risk EG00146 affected208 at risk EG00228 affected176 at risk
Platelet count decreased	Investigations	27.1	Systematic Assessment	EG0002 affected111 at risk EG00114 affected208 at risk EG00218 affected176 at risk
Weight decreased	Investigations	27.1	Systematic Assessment	EG0003 affected111 at risk EG00112 affected208 at risk EG00210 affected176 at risk
White blood cell count decreased	Investigations	27.1	Systematic Assessment	EG0004 affected111 at risk EG00126 affected208 at risk EG00216 affected176 at risk
Decreased appetite	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG00018 affected111 at risk EG00153 affected208 at risk EG00247 affected176 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0006 affected111 at risk EG0017 affected208 at risk EG0025 affected176 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected111 at risk EG0019 affected208 at risk EG00210 affected176 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG00118 affected208 at risk EG00210 affected176 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.1	Systematic Assessment	EG0002 affected111 at risk EG00116 affected208 at risk EG0028 affected176 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG00012 affected111 at risk EG00113 affected208 at risk EG00214 affected176 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0006 affected111 at risk EG00112 affected208 at risk EG0028 affected176 at risk
Dizziness	Nervous system disorders	27.1	Systematic Assessment	EG00010 affected111 at risk EG00110 affected208 at risk EG0029 affected176 at risk
Dysgeusia	Nervous system disorders	27.1	Systematic Assessment	EG0007 affected111 at risk EG00110 affected208 at risk EG0024 affected176 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG0008 affected111 at risk EG00116 affected208 at risk EG0028 affected176 at risk
Neuropathy peripheral	Nervous system disorders	27.1	Systematic Assessment	EG0000 affected111 at risk EG0014 affected208 at risk EG00210 affected176 at risk
Anxiety	Psychiatric disorders	27.1	Systematic Assessment	EG0008 affected111 at risk EG0018 affected208 at risk EG0024 affected176 at risk
Insomnia	Psychiatric disorders	27.1	Systematic Assessment	EG0008 affected111 at risk EG00115 affected208 at risk EG00214 affected176 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00015 affected111 at risk EG00131 affected208 at risk EG00222 affected176 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00016 affected111 at risk EG00118 affected208 at risk EG00215 affected176 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0003 affected111 at risk EG00130 affected208 at risk EG00218 affected176 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0006 affected111 at risk EG00110 affected208 at risk EG0022 affected176 at risk
Alopecia	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG0001 affected111 at risk EG00128 affected208 at risk EG00220 affected176 at risk
Pruritus	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00017 affected111 at risk EG0017 affected208 at risk EG00213 affected176 at risk
Rash	Skin and subcutaneous tissue disorders	27.1	Systematic Assessment	EG00017 affected111 at risk EG0017 affected208 at risk EG00225 affected176 at risk

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000600	Amino Acids, Dicarboxylic
D056831	Coordination Complexes

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
D002945	Cisplatin
D000077235	Vinorelbine
D000093542	Gemcitabine
D000077143	Docetaxel
D000068437	Pemetrexed
D016190	Carboplatin
D017239	Paclitaxel
D000074324	Ipilimumab