A Study Comparing Nivolumab, Nivolumab in Combination Wit... | NCT03138512

ID	Type	Description	Link
2016-004502-34	EudraCT Number

Label	Type	Intervention Names
Part A, Arm A: nivolumab + ipilimumab	Experimental	Biological: nivolumab Biological: ipilimumab
Part A, Arm B: nivolumab placebo + ipilimumab placebo	Placebo Comparator	Drug: nivolumab placebo Drug: ipilimumab placebo
Part B, Arm A: nivolumab + ipilimumab	Experimental	Biological: nivolumab Biological: ipilimumab
Part B, Arm B: nivolumab placebo + ipilimumab placebo	Placebo Comparator	Drug: nivolumab placebo Drug: ipilimumab placebo
Part B, Arm C: nivolumab + ipilimumab placebo	Experimental	Biological: nivolumab Drug: ipilimumab placebo

Name	Type	Description	Arm Group Labels	Other Names
nivolumab	Biological	Specified dose on specified days	Part A, Arm A: nivolumab + ipilimumab Part B, Arm A: nivolumab + ipilimumab Part B, Arm C: nivolumab + ipilimumab placebo

Measure	Description	Time Frame
Disease-Free Survival (DFS) by BICR - Treatment Part A and B	Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.	From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

Measure	Description	Time Frame
Overall Survival (OS) - Treatment Part A and B	Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates.	From randomization to the date of death (up to approximately 72 months)

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0019		Birmingham	Alabama	35205	United States
Local Institution - 0056

PubMed Identifier	Type	Citation	Retractions
39303200	Derived	Motzer RJ, Bex A, Russo P, Tomita Y, Cutuli HJ, Rojas C, Gross-Goupil M, Schinzari G, Melichar B, Barthelemy P, Ruiz Garcia A, Sosman J, Grimm MO, Goh JC, Suarez C, Kollmannsberger CK, Nair SG, Shuch BM, Huang J, Simsek B, Spiridigliozzi J, Lee CW, van Kooten Losio M, Grunwald V. Adjuvant Nivolumab for Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy: Part B of the Randomized, Placebo-Controlled, Phase III CheckMate 914 Trial. J Clin Oncol. 2025 Jan 10;43(2):189-200. doi: 10.1200/JCO.24.00773. Epub 2024 Sep 20.
36774933

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
FG001	Treatment Part A: Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 8, 2022

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

Disease-Free Survival (DFS) by BICR - Treatment Part A and B

Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.

All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms) and Treatment Part B (Placebo and Nivo Arms). The Nivo + Ipi Arm was prespecified to be excluded from the endpoint objective for Treatment Part B.

Posted

Median

95% Confidence Interval

Months

From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

ID	Title	Description
OG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part A: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
OG002	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG003	Treatment Part B: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
OG004	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).

Units	Counts
Participants	OG000405 OG001411 OG0020 OG003

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Insufficient number of participants with events OG001NA(65.58 to NA)Insufficient number of participants with events OG003NA

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		0.6676		Cox Proportional Hazard	0.95				95	0.75	1.20					Superiority
OG001 OG004		Log Rank		0.6556

Secondary

Overall Survival (OS) - Treatment Part A and B

Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the participants was known to be alive. Based on Kaplan-Meier estimates.

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death (up to approximately 72 months)

ID	Title	Description
OG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part A: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
OG002	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).

Secondary

Overall Survival (OS) Rate (5 Years) - Treatment Part A and B

Overall survival rate at 5 years is defined as the percentage of participants who are alive at 5 years.

All randomized participants in Treatment Part A (Nivo + Ipi and Placebo Arms). Data was not collected for Treatment Part B.

Posted

Number

95% Confidence Interval

Percent of participants

At 5 years

ID	Title	Description
OG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part A: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
OG002	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG003	Treatment Part B: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.

Secondary

Disease-Free Survival (DFS) Per BICR in Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B

All randomized Nivo + Ipi and Nivo participants in Treatment Part B. Prespecified to be collected for Treatment Part B only. The Placebo Arm was prespecified to be excluded from the endpoint objective.

Posted

Median

95% Confidence Interval

Months

From randomization to development of local disease recurrence, distance metastasis, or death, whichever came first (up to approximately 72 months)

ID	Title	Description
OG000	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).

Secondary

Overall Survival (OS) in the Contemporaneously Randomized Combination and Monotherapy Participants - Treatment Part B

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death (up to approximately 72 months)

ID	Title	Description
OG000	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).

Units	Counts
Participants

Secondary

The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part A

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Graded according to NCI CTCAE (Version 4) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

All Treated Participants in Treatment Part A

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (up to approximately 40 weeks)

ID	Title	Description
OG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part A: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.

Units	Counts
Participants

Secondary

The Number of Participants With Adverse Events up to 30 Days After Last Dose of Study Therapy - Treatment Part B

All Treated Participants in Treatment Part B

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (up to approximately 40 weeks)

ID	Title	Description
OG000	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part B: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
OG002	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).

Secondary

The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part A

All Treated Participants in Treatment Part A

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (up to approximately 50 weeks)

ID	Title	Description
OG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part A: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.

Units	Counts
Participants

Secondary

The Number of Participants With Adverse Events up to 100 Days After Last Dose of Study Therapy - Treatment Part B

All Treated Participants in Treatment Part B

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (up to approximately 50 weeks)

ID	Title	Description
OG000	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part B: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
OG002	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).

Secondary

The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part A

Graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE, Version 4.0] where grade 3 = severe, and grade 4 = life-threatening. Baseline evaluations are defined as evaluations or events that occur before the date and time of the first dose of study treatment.

All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (up to approximately 40 weeks)

ID	Title	Description
OG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part A: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.

Units	Counts
Participants

Secondary

The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 30 Days - Treatment Part B

All treated participants in Treatment Part B with a CTC graded laboratory result for the given parameter from both baseline and on-treatment

Posted

Count of Participants

Participants

From first dose to 30 days post last dose (up to approximately 40 weeks)

ID	Title	Description
OG000	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part B: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
OG002	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).

Secondary

The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part A

All treated participants in Treatment Part A with a CTC graded laboratory result for the given parameter from both baseline and on-treatment

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (up to approximately 50 weeks)

ID	Title	Description
OG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part A: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.

Units	Counts
Participants

Secondary

The Number of Participants Experiencing Laboratory Parameters by Worst CTC (Grade 3-4) That Worsened Relative to Baseline up to 100 Days - Treatment Part B

All treated participants in Treatment Part B with a CTC graded laboratory result for the given parameter from both baseline and on-treatment

Posted

Count of Participants

Participants

From first dose to 100 days post last dose (up to approximately 50 weeks)

ID	Title	Description
OG000	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
OG001	Treatment Part B: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
OG002	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Acute coronary syndrome	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Acute myocardial infarction	Cardiac disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Angina pectoris	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Atrial fibrillation	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0022 affected408 at risk
Atrial flutter	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Cardiac arrest	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Cardiac failure	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Cardiac tamponade	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Myocardial infarction	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Myocardial injury	Cardiac disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Myocarditis	Cardiac disorders	26.1	Systematic Assessment	EG0003 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Palpitations	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Sinus node dysfunction	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Stress cardiomyopathy	Cardiac disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Paraduodenal hernia	Congenital, familial and genetic disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Vertigo	Ear and labyrinth disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Adrenal insufficiency	Endocrine disorders	26.1	Systematic Assessment	EG00021 affected608 at risk EG0010 affected614 at risk EG0023 affected408 at risk
Adrenocortical insufficiency acute	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Adrenocorticotropic hormone deficiency	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Autoimmune thyroiditis	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hypercalcaemia of malignancy	Endocrine disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Hyperthyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hypophysitis	Endocrine disorders	26.1	Systematic Assessment	EG00012 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hypopituitarism	Endocrine disorders	26.1	Systematic Assessment	EG0004 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hypothyroidism	Endocrine disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Lymphocytic hypophysitis	Endocrine disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Thyroiditis	Endocrine disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Cataract	Eye disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Diplopia	Eye disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Orbital myositis	Eye disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Retinal detachment	Eye disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Retinal vein occlusion	Eye disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Serous retinal detachment	Eye disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Uveitis	Eye disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Abdominal hernia	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Abdominal pain	Gastrointestinal disorders	26.1	Systematic Assessment	EG0004 affected608 at risk EG0011 affected614 at risk EG0021 affected408 at risk
Abdominal pain upper	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Autoimmune colitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Colitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG00012 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Colitis ischaemic	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Diarrhoea	Gastrointestinal disorders	26.1	Systematic Assessment	EG00016 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Duodenal ulcer	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Gastric ulcer	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0012 affected614 at risk EG0020 affected408 at risk
Gastritis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Haematemesis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Immune-mediated enterocolitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0006 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Intestinal perforation	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Mesenteric panniculitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Nausea	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Pancreatitis	Gastrointestinal disorders	26.1	Systematic Assessment	EG0003 affected608 at risk EG0010 affected614 at risk EG0022 affected408 at risk
Pancreatitis acute	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Small intestinal obstruction	Gastrointestinal disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Vomiting	Gastrointestinal disorders	26.1	Systematic Assessment	EG0005 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Death	General disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Disease recurrence	General disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Fatigue	General disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
General physical health deterioration	General disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Influenza like illness	General disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Malaise	General disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Mucosal inflammation	General disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Multiple organ dysfunction syndrome	General disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Non-cardiac chest pain	General disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Pyrexia	General disorders	26.1	Systematic Assessment	EG0004 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Sudden death	General disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Autoimmune hepatitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Cholecystitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Cholecystitis acute	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Drug-induced liver injury	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0011 affected614 at risk EG0021 affected408 at risk
Hepatic cytolysis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Hepatic failure	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Hepatic function abnormal	Hepatobiliary disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hepatitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Hydrocholecystis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hypertransaminasaemia	Hepatobiliary disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Subacute hepatic failure	Hepatobiliary disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hypersensitivity	Immune system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Sarcoidosis	Immune system disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Abdominal sepsis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Appendicitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0021 affected408 at risk
COVID-19	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0011 affected614 at risk EG0021 affected408 at risk
COVID-19 pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Clostridium difficile infection	Infections and infestations	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Cytomegalovirus colitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Diverticulitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Encephalitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Enterocolitis infectious	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Febrile infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Gastrointestinal fungal infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hepatitis E	Infections and infestations	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Herpes zoster meningitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Klebsiella sepsis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Meningitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Meningitis aseptic	Infections and infestations	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Peritonitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Pneumonia	Infections and infestations	26.1	Systematic Assessment	EG0006 affected608 at risk EG0011 affected614 at risk EG0021 affected408 at risk
Postoperative wound infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Pyelonephritis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Sepsis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0012 affected614 at risk EG0021 affected408 at risk
Septic shock	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Sinusitis	Infections and infestations	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Skin infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Spontaneous bacterial peritonitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Upper respiratory tract infection	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Urinary tract infection	Infections and infestations	26.1	Systematic Assessment	EG0004 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Vestibular neuronitis	Infections and infestations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Arterial injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Femur fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0021 affected408 at risk
Heat stroke	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hip fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Infusion related reaction	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Open fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Post procedural complication	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Splenic injury	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Traumatic fracture	Injury, poisoning and procedural complications	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Alanine aminotransferase increased	Investigations	26.1	Systematic Assessment	EG0003 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
General physical condition abnormal	Investigations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Liver function test increased	Investigations	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Dehydration	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Diabetes mellitus	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0003 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0003 affected608 at risk EG0010 affected614 at risk EG0023 affected408 at risk
Gout	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Hypercalcaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hyperglycaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0005 affected608 at risk EG0010 affected614 at risk EG0023 affected408 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hyperkalaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Hypoglycaemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hyponatraemia	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0006 affected608 at risk EG0010 affected614 at risk EG0022 affected408 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0004 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Back pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0012 affected614 at risk EG0020 affected408 at risk
Bone pain	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Immune-mediated myositis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Myalgia	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Myositis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected608 at risk EG0012 affected614 at risk EG0020 affected408 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected608 at risk EG0012 affected614 at risk EG0020 affected408 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected608 at risk EG0012 affected614 at risk EG0020 affected408 at risk
Recurrent cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0002 affected608 at risk EG0013 affected614 at risk EG0022 affected408 at risk
Renal cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Carpal tunnel syndrome	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Cerebral infarction	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Cerebrovascular accident	Nervous system disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Diabetic neuropathy	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Dizziness	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Encephalitis autoimmune	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Epilepsy	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Facial paralysis	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Guillain-Barre syndrome	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Haemorrhage intracranial	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Headache	Nervous system disorders	26.1	Systematic Assessment	EG0003 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hemiparesis	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hypoaesthesia	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Immune-mediated encephalitis	Nervous system disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Ischaemic cerebral infarction	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Ischaemic stroke	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Neurological decompensation	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Osmotic demyelination syndrome	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Peripheral sensory neuropathy	Nervous system disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Polyneuropathy	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Sciatica	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Spinal cord compression	Nervous system disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Syncope	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Tension headache	Nervous system disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Device breakage	Product Issues	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Depression	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Major depression	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Panic attack	Psychiatric disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Suicidal ideation	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0021 affected408 at risk
Suicide attempt	Psychiatric disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Acute kidney injury	Renal and urinary disorders	26.1	Systematic Assessment	EG00013 affected608 at risk EG0011 affected614 at risk EG0022 affected408 at risk
Bladder hypertrophy	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Chronic kidney disease	Renal and urinary disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Immune-mediated nephritis	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Nephritis	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Nephropathy	Renal and urinary disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Urinary tract obstruction	Renal and urinary disorders	26.1	Systematic Assessment	EG0002 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Prostatitis	Reproductive system and breast disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Uterine polyp	Reproductive system and breast disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0011 affected614 at risk EG0021 affected408 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0007 affected608 at risk EG0011 affected614 at risk EG0024 affected408 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	26.1	Systematic Assessment	EG0003 affected608 at risk EG0012 affected614 at risk EG0021 affected408 at risk
Angioedema	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Dermatitis	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Drug eruption	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Assisted suicide	Surgical and medical procedures	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Aortic dissection	Vascular disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Deep vein thrombosis	Vascular disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Embolism	Vascular disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Haematoma	Vascular disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk
Hypertensive crisis	Vascular disorders	26.1	Systematic Assessment	EG0000 affected608 at risk EG0010 affected614 at risk EG0021 affected408 at risk
Hypotension	Vascular disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0011 affected614 at risk EG0020 affected408 at risk
Thrombophlebitis	Vascular disorders	26.1	Systematic Assessment	EG0001 affected608 at risk EG0010 affected614 at risk EG0020 affected408 at risk

ID	Term
D002292	Carcinoma, Renal Cell
D007680	Kidney Neoplasms
D012008	Recurrence

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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

ID	Title	Description
BG000	Treatment Part A: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
BG001	Treatment Part A: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
BG002	Treatment Part B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).
BG003	Treatment Part B: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.
BG004	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).
BG005	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Part A and B: Nivo + Ipi	Nivolumab 240 mg every 2 weeks and ipilimumab 1 mg/kg every 6 weeks (or every third nivolumab dose if dosing is delayed).	65	611	196	608	544	608
EG001	Treatment Part A and B: Placebo	Placebo infusions at the same frequency of nivolumab and ipilimumab infusions.	55	619	49	614	469	614
EG002	Treatment Part B: Nivo	Nivolumab 240 mg every 2 weeks and ipilimumab Placebo every 6 weeks (or every third nivolumab dose if dosing is delayed).	22	411	56	408	325	408