A Study to Test Combination Treatments in Participants Wi... | NCT02935634

ID	Type	Description	Link
2016-002807-24	EudraCT Number

Name	Class
Clovis Oncology, Inc.	INDUSTRY

Label	Type	Intervention Names
Nivolumab + Ipilimumab	Active Comparator	Biological: Nivolumab Biological: Ipilimumab
Nivolumab + Relatlimab	Experimental	Biological: Nivolumab Biological: Relatlimab
Nivolumab + BMS-986205	Experimental	Biological: Nivolumab Biological: BMS-986205
Nivolumab + Rucaparib	Experimental	Biological: Nivolumab Drug: Rucaparib
Ipilimumab + Rucaparib	Experimental	Biological: Ipilimumab Drug: Rucaparib
Nivolumab + Ipilimumab + Rucaparib	Experimental	Biological: Nivolumab Biological: Ipilimumab Drug: Rucaparib

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	Specified dose on specified days	Nivolumab + BMS-986205 Nivolumab + Ipilimumab Nivolumab + Ipilimumab + Rucaparib

Measure	Description	Time Frame
Objective Response Rate (ORR) by Investigator	ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.	From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)
Median Duration of Response (DOR)	Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.	From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)
Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks	The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is 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. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.

Measure	Description	Time Frame
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death	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. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

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

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Phoenix	Arizona	85054	United States
Local Institution - 0020

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source
Investigator Inquiry Form

ID	Title	Description
FG000	Nivolumab + Ipilimumab	Participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
FG001	Nivolumab + BMS-986016

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	Aug 13, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Objective Response Rate (ORR) by Investigator

ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.

All treated participants

Posted

Number

95% Confidence Interval

Percent of participants

From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)

ID	Title	Description
OG000	Track 1: Nivolumab + Ipilimumab	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
OG001	Track 1: Nivolumab + BMS-986016	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
OG002	Track 1: Nivolumab + BMS-986205	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
OG003	Track 1: Nivolumab + Rucaparib	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
OG004	Track 1: Ipilimumab + Rucaparib	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
OG005	Track 1: Nivolumab + Ipilimumab + Rucaparib	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
OG006	Track 2: Nivolumab + Ipilimumab	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
OG007	Track 2: Nivolumab + BMS-986016	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
OG008	Track 2: Nivolumab + BMS-986205	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
OG009	Track 2: Nivolumab + Rucaparib	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
OG010	Track 2: Ipilimumab + Rucaparib	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
OG011	Track 2: Nivolumab + Ipilimumab + Rucaparib	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.

Units	Counts
Participants	OG00023 OG00120 OG00238 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004.3(0.1 to 21.9) OG0015.0(0.1 to 24.9) OG00213.2(4.4 to 28.1) OG003

Primary

Median Duration of Response (DOR)

Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.

All treated participants with a complete response (CR) or partial response (PR)

Posted

Median

Full Range

Weeks

From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)

ID	Title	Description
OG000	Track 1: Nivolumab + Ipilimumab	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
OG001	Track 1: Nivolumab + BMS-986016	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
OG002

Primary

Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks

The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is 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. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.

All treated participants

Posted

Number

95% Confidence Interval

Proportion of participants

24 weeks after first dose

ID	Title	Description
OG000	Track 1: Nivolumab + Ipilimumab	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
OG001	Track 1: Nivolumab + BMS-986016	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
OG002	Track 1: Nivolumab + BMS-986205

Secondary

Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death

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. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

All treated participants

Posted

Number

Participants

From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)

ID	Title	Description
OG000	Track 1: Nivolumab + Ipilimumab	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
OG001	Track 1: Nivolumab + BMS-986016	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.

Secondary

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

The number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.

All treated participants with at least one on-treatment TSH measurement

Posted

Count of Participants

Participants

From first dose to 100 days after last dose of study therapy (approximately 30 months)

ID	Title	Description
OG000	Track 1: Nivolumab + Ipilimumab	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
OG001	Track 1: Nivolumab + BMS-986016	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
OG002	Track 1: Nivolumab + BMS-986205	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.

Secondary

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

The number of participants with laboratory abnormalities in specific liver tests based on US conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement

Posted

Count of Participants

Participants

From first dose to 100 days after last dose of study therapy (approximately 30 months)

ID	Title	Description
OG000	Track 1: Nivolumab + Ipilimumab	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
OG001	Track 1: Nivolumab + BMS-986016	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
OG002	Track 1: Nivolumab + BMS-986205	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0013 affected20 at risk EG0022 affected38 at risk EG0030 affected7 at risk EG0040 affected8 at risk EG0050 affected6 at risk EG0062 affected23 at risk EG0071 affected36 at risk EG0080 affected22 at risk EG0090 affected6 at risk EG0100 affected2 at risk EG0111 affected4 at risk
Febrile neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Atrial fibrillation	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Supraventricular tachycardia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Adrenal insufficiency	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Basedow's disease	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Lymphocytic hypophysitis	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Secondary adrenocortical insufficiency	Endocrine disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Ascites	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Duodenal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Dysphagia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0012 affected20 at risk EG0024 affected38 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Gastric perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Haematemesis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Ileus	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Large intestine perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Oesophageal perforation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0020 affected38 at risk EG003
Asthenia	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Chest discomfort	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Death	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Fatigue	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
General physical health deterioration	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Multiple organ dysfunction syndrome	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Non-cardiac chest pain	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Pain	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Performance status decreased	General disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Pyrexia	General disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Sudden death	General disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Systemic inflammatory response syndrome	General disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Cholecystitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hepatic failure	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hepatic haematoma	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Atypical pneumonia	Infections and infestations	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Clostridium difficile infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Ophthalmic herpes zoster	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Pneumonia viral	Infections and infestations	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Sepsis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Skin bacterial infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Streptococcal bacteraemia	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Upper respiratory tract infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Vascular device infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Wound infection	Infections and infestations	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Fall	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Blood bilirubin increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Blood creatinine increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hepatic enzyme increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Weight decreased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG00011 affected23 at risk EG0016 affected20 at risk EG00211 affected38 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Tumour perforation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Brain oedema	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Cerebral infarction	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Cerebrovascular accident	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Encephalopathy	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Haemorrhage intracranial	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Seizure	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Syncope	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Transient ischaemic attack	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Device dislocation	Product Issues	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Delirium	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Acute kidney injury	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0003 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0003 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Embolism	Vascular disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Hypotension	Vascular disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Superior vena cava stenosis	Vascular disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0006 affected23 at risk EG0018 affected20 at risk EG00212 affected38 at risk EG0031 affected7 at risk EG0043 affected8 at risk EG0052 affected6 at risk EG0067 affected23 at risk EG00711 affected36 at risk EG0087 affected22 at risk EG0091 affected6 at risk EG0100 affected2 at risk EG0111 affected4 at risk
Coagulopathy	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Neutropenia	Blood and lymphatic system disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Atrial fibrillation	Cardiac disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Palpitations	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Sinus tachycardia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Tachycardia	Cardiac disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Vertigo	Ear and labyrinth disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hyperthyroidism	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hypothyroidism	Endocrine disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0013 affected20 at risk EG0024 affected38 at risk EG003
Vision blurred	Eye disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Abdominal distension	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected20 at risk EG0023 affected38 at risk EG003
Abdominal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG0007 affected23 at risk EG0017 affected20 at risk EG00211 affected38 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0013 affected20 at risk EG0020 affected38 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0014 affected20 at risk EG0022 affected38 at risk EG003
Ascites	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Colitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Constipation	Gastrointestinal disorders	25.0	Systematic Assessment	EG0003 affected23 at risk EG0015 affected20 at risk EG0029 affected38 at risk EG003
Diarrhoea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0015 affected20 at risk EG0027 affected38 at risk EG003
Dry mouth	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Dyspepsia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0022 affected38 at risk EG003
Dysphagia	Gastrointestinal disorders	25.0	Systematic Assessment	EG0006 affected23 at risk EG0013 affected20 at risk EG0028 affected38 at risk EG003
Flatulence	Gastrointestinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0023 affected38 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0014 affected20 at risk EG0022 affected38 at risk EG003
Ileus	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Jejunal stenosis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Nausea	Gastrointestinal disorders	25.0	Systematic Assessment	EG0008 affected23 at risk EG00110 affected20 at risk EG00217 affected38 at risk EG003
Oesophageal pain	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Stomatitis	Gastrointestinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Vomiting	Gastrointestinal disorders	25.0	Systematic Assessment	EG0007 affected23 at risk EG0015 affected20 at risk EG0027 affected38 at risk EG003
Asthenia	General disorders	25.0	Systematic Assessment	EG0004 affected23 at risk EG0013 affected20 at risk EG0024 affected38 at risk EG003
Chills	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Early satiety	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Fatigue	General disorders	25.0	Systematic Assessment	EG00013 affected23 at risk EG00111 affected20 at risk EG00223 affected38 at risk EG003
General physical health deterioration	General disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Influenza like illness	General disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Malaise	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Mucosal inflammation	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Non-cardiac chest pain	General disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0023 affected38 at risk EG003
Oedema peripheral	General disorders	25.0	Systematic Assessment	EG0003 affected23 at risk EG0011 affected20 at risk EG0023 affected38 at risk EG003
Pain	General disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Pyrexia	General disorders	25.0	Systematic Assessment	EG0007 affected23 at risk EG0013 affected20 at risk EG0028 affected38 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Bronchitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
COVID-19	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Cellulitis	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Clostridium difficile infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Genital herpes	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Lymph gland infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Paronychia	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Pneumonia	Infections and infestations	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Sepsis	Infections and infestations	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Urinary tract infection	Infections and infestations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Contusion	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Fall	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Alanine aminotransferase increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0015 affected20 at risk EG0027 affected38 at risk EG003
Amylase increased	Investigations	25.0	Systematic Assessment	EG0001 affected23 at risk EG0013 affected20 at risk EG0024 affected38 at risk EG003
Aspartate aminotransferase increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0015 affected20 at risk EG0028 affected38 at risk EG003
Blood alkaline phosphatase increased	Investigations	25.0	Systematic Assessment	EG0003 affected23 at risk EG0013 affected20 at risk EG0025 affected38 at risk EG003
Blood bilirubin increased	Investigations	25.0	Systematic Assessment	EG0002 affected23 at risk EG0016 affected20 at risk EG0023 affected38 at risk EG003
Blood creatine increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Blood creatine phosphokinase increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0022 affected38 at risk EG003
Blood creatinine increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0023 affected38 at risk EG003
Blood pressure increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Blood urea increased	Investigations	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
C-reactive protein increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Electrocardiogram QT prolonged	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Gamma-glutamyltransferase increased	Investigations	25.0	Systematic Assessment	EG0004 affected23 at risk EG0012 affected20 at risk EG0022 affected38 at risk EG003
Glomerular filtration rate decreased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
International normalised ratio increased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Lipase increased	Investigations	25.0	Systematic Assessment	EG0002 affected23 at risk EG0013 affected20 at risk EG0023 affected38 at risk EG003
Lymph node palpable	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Lymphocyte count decreased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Neutrophil count decreased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Platelet count decreased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0022 affected38 at risk EG003
Weight decreased	Investigations	25.0	Systematic Assessment	EG0004 affected23 at risk EG0012 affected20 at risk EG0024 affected38 at risk EG003
White blood cell count decreased	Investigations	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0021 affected38 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG00010 affected23 at risk EG00110 affected20 at risk EG0029 affected38 at risk EG003
Dehydration	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0023 affected38 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0012 affected20 at risk EG0024 affected38 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0003 affected23 at risk EG0015 affected20 at risk EG0024 affected38 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0022 affected38 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0003 affected23 at risk EG0013 affected20 at risk EG0021 affected38 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0012 affected20 at risk EG0023 affected38 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0005 affected23 at risk EG0015 affected20 at risk EG0024 affected38 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0013 affected20 at risk EG0021 affected38 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0014 affected20 at risk EG0022 affected38 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0020 affected38 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0015 affected20 at risk EG0023 affected38 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected20 at risk EG0020 affected38 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0012 affected20 at risk EG0020 affected38 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0012 affected20 at risk EG0024 affected38 at risk EG003
Sacral pain	Musculoskeletal and connective tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Disturbance in attention	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Dizziness	Nervous system disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected20 at risk EG0025 affected38 at risk EG003
Dysgeusia	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0014 affected20 at risk EG0020 affected38 at risk EG003
Headache	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0026 affected38 at risk EG003
Paraesthesia	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0023 affected38 at risk EG003
Polyneuropathy	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Restless legs syndrome	Nervous system disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Tremor	Nervous system disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Anxiety	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Confusional state	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Depression	Psychiatric disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Insomnia	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0023 affected38 at risk EG003
Panic attack	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Restlessness	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Suicidal ideation	Psychiatric disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Dysuria	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Proteinuria	Renal and urinary disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Ejaculation disorder	Reproductive system and breast disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Oedema genital	Reproductive system and breast disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0006 affected23 at risk EG0014 affected20 at risk EG0028 affected38 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0004 affected23 at risk EG0012 affected20 at risk EG0027 affected38 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0011 affected20 at risk EG0021 affected38 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0012 affected20 at risk EG0020 affected38 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0013 affected20 at risk EG0020 affected38 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0022 affected38 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0002 affected23 at risk EG0011 affected20 at risk EG0024 affected38 at risk EG003
Rash	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0012 affected20 at risk EG0024 affected38 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0005 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0003 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Deep vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0010 affected20 at risk EG0021 affected38 at risk EG003
Hypertension	Vascular disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0023 affected38 at risk EG003
Hypotension	Vascular disorders	25.0	Systematic Assessment	EG0001 affected23 at risk EG0011 affected20 at risk EG0022 affected38 at risk EG003
Jugular vein thrombosis	Vascular disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003
Orthostatic hypotension	Vascular disorders	25.0	Systematic Assessment	EG0000 affected23 at risk EG0010 affected20 at risk EG0020 affected38 at risk EG003

ID	Term
D000077594	Nivolumab
D000074324	Ipilimumab
C000721227	relatlimab
C000630574	linrodostat
C531549	rucaparib

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	Track 1: Nivolumab + Ipilimumab	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
BG001	Track 1: Nivolumab + BMS-986016	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
BG002	Track 1: Nivolumab + BMS-986205	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
BG003	Track 1: Nivolumab + Rucaparib	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
BG004	Track 1: Ipilimumab + Rucaparib	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
BG005	Track 1: Nivolumab + Ipilimumab + Rucaparib	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
BG006	Track 2: Nivolumab + Ipilimumab	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
BG007	Track 2: Nivolumab + BMS-986016	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
BG008	Track 2: Nivolumab + BMS-986205	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
BG009	Track 2: Nivolumab + Rucaparib	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
BG010	Track 2: Ipilimumab + Rucaparib	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
BG011	Track 2: Nivolumab + Ipilimumab + Rucaparib	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
BG012	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	Track 1: Nivolumab + Ipilimumab	Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	19	23	19	23	21	23
EG001	Track 1: Nivolumab + BMS-986016	Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	15	23	15	20	20	20
EG002	Track 1: Nivolumab + BMS-986205	Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	26	39	24	38	38	38
EG003	Track 1: Nivolumab + Rucaparib	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	7	7	5	7	7	7
EG004	Track 1: Ipilimumab + Rucaparib	Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	5	8	6	8	8	8
EG005	Track 1: Nivolumab + Ipilimumab + Rucaparib	Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	4	6	4	6	6	6
EG006	Track 2: Nivolumab + Ipilimumab	Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.	19	28	17	23	23	23
EG007	Track 2: Nivolumab + BMS-986016	Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.	26	41	24	36	34	36
EG008	Track 2: Nivolumab + BMS-986205	Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.	13	25	12	22	21	22
EG009	Track 2: Nivolumab + Rucaparib	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.	3	6	4	6	6	6
EG010	Track 2: Ipilimumab + Rucaparib	Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.	2	2	2	2	2	2
EG011	Track 2: Nivolumab + Ipilimumab + Rucaparib	Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.	3	4	3	4	4	4