A Study of the Effectiveness and Safety of Nivolumab Comp... | NCT02017717

NCT02017717

ID	Type	Description	Link
2013-003738-34	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm N:Nivolumab	Experimental	Cohort 1, 1c, 1d and 2: Nivolumab specified dose on specified days	Biological: Nivolumab
Arm N + I:Nivolumab + Ipilimumab	Experimental	Cohort 1: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days Cohort 1b: Nivolumab specified dose on specified days + Ipilimumab specified dose on specified days, then Nivolumab specified dose on specified days	Biological: Nivolumab Biological: Ipilimumab
Arm B: Bevacizumab	Active Comparator	Cohort 2: Bevacizumab specified dose on specified days	Biological: Bevacizumab

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Biological	specified dose on specified days	Arm N + I:Nivolumab + Ipilimumab Arm N:Nivolumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses	The percentage of participants who experienced a drug-related adverse event leading to drug discontinuation by worst grade (grade 5 being the worst) prior to complete four-dose treatment. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1	Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months)
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d	The percentage of participants who experienced an adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1	From first dose to 30 days post last dose (up to approximately 34 months).
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d	The percentage of participants who experienced a serious adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1	From first dose to 30 days post last dose (up to approximately 34 months).
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d	The percentage of participants who experienced a laboratory abnormality of the liver in each treatment arm. MedDRA Version: 24.1 Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Denominator corresponds to participants with at least on one treatment measurement of the corresponding laboratory parameter. Includes laboratory results reported after the first dose and within 30 days of last dose of study therapy.

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) at 12 Months for Cohort 2	OS(12) is measured as the percentage of participants alive at 12 months per Kaplan-Meier curve of OS. Z test with variance estimation based on Greenwood formula using log(-log) transformation.	From randomization to 12 months following randomization
Overall Survival (OS) for Cohorts 1c and 1d

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-3410	United States
Cedars Sinai Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39777725	Derived	de Melo SM, Elias Nunes da Silva ME, Torloni MR, Riera R, De Cicco K, Latorraca CO, Pinto ACPN. Anti-PD-1 and anti-PD-L1 antibodies for glioma. Cochrane Database Syst Rev. 2025 Jan 8;1(1):CD012532. doi: 10.1002/14651858.CD012532.pub2.
32691060	Derived	Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1: Arm N1+I3	Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
FG001	Cohort 1: Arm N3

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 16, 2016	Jun 1, 2022

Arm/Group Information

ID	Title	Description
BG000	Cohort 1: Arm N1+I3	Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
BG001	Cohort 1: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
BG002	Cohort 1b: Arm N3+I1	Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
BG003	Part A Cohort 1c: Arm N3+RT+TMZ	Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
BG004	Part A Cohort 1d: Arm N3+RT	Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
BG005	Part B Cohort 1c: Arm N3+RT+TMZ	Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
BG006	Part B Cohort 1d: Arm N3+RT	Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
BG007	Cohort 2: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
BG008	Cohort 2: Arm B	Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
BG009	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00054.5± 11.3 BG00158.6± 10.9 BG00255.0± 11.9 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 65	BG0007 BG0016 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004 BG0015 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Race only

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses

The percentage of participants who experienced a drug-related adverse event leading to drug discontinuation by worst grade (grade 5 being the worst) prior to complete four-dose treatment. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1

All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses

Posted

Number

Percentage of participants

Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months)

ID	Title	Description
OG000	Cohort 1: Arm N1+I3	Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
OG001	Cohort 1: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG002	Cohort 1b: Arm N3+I1	Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
OG003	Part A Cohort 1c: Arm N3+RT+TMZ	Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
OG004	Part A Cohort 1d: Arm N3+RT	Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
OG005	Part B Cohort 1c: Arm N3+RT+TMZ	Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
OG006	Part B Cohort 1d: Arm N3+RT	Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy

Units	Counts
Participants	OG0006 OG0014 OG0027 OG003

Title

Denominators

Categories

Grade 1

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d

The percentage of participants who experienced an adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1

All Treated Participants in Cohorts 1, 1b, 1c and 1d

Posted

Number

Percentage of participants

From first dose to 30 days post last dose (up to approximately 34 months).

ID	Title	Description
OG000	Cohort 1: Arm N1+I3	Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
OG001	Cohort 1: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG002	Cohort 1b: Arm N3+I1	Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
OG003

Primary

Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d

The percentage of participants who experienced a serious adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1

All Treated Participants in Cohorts 1, 1b, 1c and 1d

Posted

Number

Percentage of participants

From first dose to 30 days post last dose (up to approximately 34 months).

ID	Title	Description
OG000	Cohort 1: Arm N1+I3	Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
OG001	Cohort 1: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG002	Cohort 1b: Arm N3+I1	Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter

Primary

Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d

The percentage of participants who experienced a laboratory abnormality of the liver in each treatment arm.

MedDRA Version: 24.1

Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Denominator corresponds to participants with at least on one treatment measurement of the corresponding laboratory parameter. Includes laboratory results reported after the first dose and within 30 days of last dose of study therapy.

All Treated Subjects in Cohorts 1, 1b, 1c and 1d with at least one on-treatment measurement of the corresponding laboratory parameter

Posted

Number

Percentage of participants

From first dose to 30 days post last dose (up to approximately 34 months).

ID	Title	Description
OG000	Cohort 1: Arm N1+I3	Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
OG001	Cohort 1: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG002	Cohort 1b: Arm N3+I1

Primary

Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d

The percentage of participants who experienced a laboratory abnormality of the thyroid in each treatment arm.

MedDRA Version: 24.1

Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)

(A) Within a 2-week window after the abnormal TSH test date. (B) Includes participants with TSH abnormality and with no FT3/FT4 test values in the 2-week window or with non-abnormal value(s) from only one of the two tests and no value from the other test.

All Treated Subjects in Cohorts 1, 1b, 1c and 1d with at Least One On-Treatment TSH measurement

Posted

Number

Percentage of participants

From first dose to 30 days post last dose (up to approximately 34 months).

ID	Title	Description
OG000	Cohort 1: Arm N1+I3	Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
OG001	Cohort 1: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG002	Cohort 1b: Arm N3+I1	Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter

Primary

Overall Survival (OS) for Cohort 2

OS was measured in months from the time of randomization to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date.

Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS. P-value from log-rank test stratified by presence of measurable lesions at baseline per IVRS.

All Randomized Participants in Cohort 2

Posted

Median

95% Confidence Interval

Months

Time between the date of randomization and the date of death due to any cause (up to up to 17Jun2019, approximately 5 years)

ID	Title	Description
OG000	Cohort 2: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG001	Cohort 2: Arm B	Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated

Units	Counts
Participants

Secondary

Overall Survival (OS) at 12 Months for Cohort 2

OS(12) is measured as the percentage of participants alive at 12 months per Kaplan-Meier curve of OS. Z test with variance estimation based on Greenwood formula using log(-log) transformation.

All Randomized Participants in Cohort 2

Posted

Number

95% Confidence Interval

Percentage of Participants

From randomization to 12 months following randomization

ID	Title	Description
OG000	Cohort 2: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG001	Cohort 2: Arm B	Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS) for Cohorts 1c and 1d

OS was measured in months from the time of randomization (Part B) or time of treatment (Part A) to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date.

Based on Kaplan-Meier Estimates.

All Randomized (Part B) or Treated (Part A) Participants in Cohorts 1c and 1d

Posted

Median

95% Confidence Interval

Months

Time between the date of randomization and the date of death due to any cause (up to approximately 10 years and 5 months)

ID	Title	Description
OG000	Part A Cohort 1c: Arm N3+RT+TMZ	Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
OG001	Part A Cohort 1d: Arm N3+RT	Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
OG002	Part B Cohort 1c: Arm N3+RT+TMZ	Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide

Secondary

Progression Free Survival (PFS) for Cohort 2

PFS was measured in months from the time of randomization to the date of the first documented tumor progression or death due to any cause. Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS.

All Randomized Participants in Cohort 2

Posted

Median

95% Confidence Interval

Months

Time from randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 10 years and 5 months)

ID	Title	Description
OG000	Cohort 2: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG001	Cohort 2: Arm B	Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated

Units	Counts
Participants	OG000

Secondary

Objective Response Rate (ORR) for Cohort 2

ORR was measured by the percentage of participants whose best overall response (BOR) is confirmed Complete Response (CR) or Partial Response (PR) divided by response evaluable participants. The best overall response (BOR) is determined once all the data for the participant is known. BOR is defined as the best response designation, as determined by investigators, recorded between the date of randomization and the date of objectively documented progression per RANO criteria, the date of subsequent therapy, or date of surgical resection, whichever occurs first.

Confidence interval based on the Clopper and Pearson method. For the comparison of the odds ratio of Nivolumab over Bevacizumab, the Cochran-Mantel-Haenszel (CMH) method of weighting was utilized.

All Response Evaluable Participants in Cohort 2

Posted

Number

95% Confidence Interval

Percentage of participants

Time from randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 10 years and 5 months)

ID	Title	Description
OG000	Cohort 2: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG001	Cohort 2: Arm B	Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated

Post-Hoc

Overall Survival (OS) for Cohort 2 - Extended Collection

OS was measured in months from the time of randomization to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date.

All Randomized Participants in Cohort 2

Posted

Median

95% Confidence Interval

Months

Time between the date of randomization and the date of death due to any cause (up to approximately 10 years and 5 months)

ID	Title	Description
OG000	Cohort 2: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
OG001	Cohort 2: Arm B	Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: Arm N1+I3	Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter	10	10	8	10	10	10
EG001	Cohort 1: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks	9	10	7	10	10	10
EG002	Cohort 1b: Arm N3+I1	Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter	20	20	15	20	20	20
EG003	Part A Cohort 1c: Arm N3+RT+TMZ	Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide	29	31	24	31	31	31
EG004	Part A Cohort 1d: Arm N3+RT	Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy	30	30	19	30	29	30
EG005	Part B Cohort 1c: Arm N3+RT+TMZ	Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide	28	29	16	28	27	28
EG006	Part B Cohort 1d: Arm N3+RT	Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy	28	30	19	28	27	28
EG007	Cohort 2: Arm N3	Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks	180	184	117	182	168	182
EG008	Cohort 2: Arm B	Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated	166	185	94	165	148	165

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG0031 affected31 at risk EG0040 affected30 at risk EG0051 affected28 at risk EG0060 affected28 at risk EG0071 affected182 at risk EG0080 affected165 at risk
Febrile neutropenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Leukopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Neutropenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Angina pectoris	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Atrial fibrillation	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Bradycardia	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cardiac arrest	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Sinus tachycardia	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Autoimmune hypothyroidism	Endocrine disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hyperthyroidism	Endocrine disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypothyroidism	Endocrine disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Eye movement disorder	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Visual impairment	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Abdominal pain	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Autoimmune pancreatitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Colitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Diarrhoea	Gastrointestinal disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Dysphagia	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Gastritis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Large intestine perforation	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Nausea	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pancreatitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Vomiting	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Asthenia	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Fatigue	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Gait disturbance	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
General physical health deterioration	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Impaired healing	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Necrosis	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Non-cardiac chest pain	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Oedema	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Performance status decreased	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pyrexia	General disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Sudden death	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cholecystitis	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Immune-mediated hepatitis	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Contrast media allergy	Immune system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypersensitivity	Immune system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Bacteraemia	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Brain abscess	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Bronchitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cellulitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Clostridium difficile colitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cystitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Encephalitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Encephalitis herpes	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Graft infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Groin abscess	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Herpes simplex encephalitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Herpes zoster	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Oesophageal infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pneumonia	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Pneumonia aspiration	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Post procedural infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Sepsis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Septic shock	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Sinusitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Subcutaneous abscess	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Upper respiratory tract infection	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Urinary tract infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fall	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Procedural haemorrhage	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Alanine aminotransferase increased	Investigations	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Aspartate aminotransferase increased	Investigations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Blood alkaline phosphatase increased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Blood bilirubin increased	Investigations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Electrocardiogram QT prolonged	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Influenza B virus test positive	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Lipase increased	Investigations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Platelet count decreased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Transaminases increased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
White blood cell count decreased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dehydration	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Haematoma muscle	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0002 affected10 at risk EG0012 affected10 at risk EG0028 affected20 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Amnesia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Aphasia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Ataxia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Brain oedema	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cerebral haemorrhage	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cerebral ischaemia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cerebrospinal fluid leakage	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cerebrovascular accident	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cognitive disorder	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Demyelination	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Depressed level of consciousness	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Dizziness	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dysarthria	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Encephalopathy	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Epilepsy	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Facial paralysis	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Haemorrhage intracranial	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Headache	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Hemianopia homonymous	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hemiparesis	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hydrocephalus	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Ischaemic stroke	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Lethargy	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Memory impairment	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Nervous system disorder	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Neurological decompensation	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Parkinson's disease	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Presyncope	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pyramidal tract syndrome	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Seizure	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Slow speech	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Somnolence	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Status epilepticus	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Syncope	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Transient ischaemic attack	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Agitation	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Anxiety	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Confusional state	Psychiatric disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0012 affected10 at risk EG0022 affected20 at risk EG003
Delirium	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hallucination	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Mental status changes	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Suicide attempt	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Acute kidney injury	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Haematuria	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Granulomatous pneumonitis	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Lichen planus	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Rash	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Deep vein thrombosis	Vascular disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Embolism	Vascular disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Flushing	Vascular disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Haemorrhage	Vascular disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypertension	Vascular disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypotension	Vascular disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Ischaemia	Vascular disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG0037 affected31 at risk EG0041 affected30 at risk EG0052 affected28 at risk EG0064 affected28 at risk EG0078 affected182 at risk EG0084 affected165 at risk
Leukopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Atrial fibrillation	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Myocardial infarction	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Palpitations	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Sinus tachycardia	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Ear congestion	Ear and labyrinth disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Tinnitus	Ear and labyrinth disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Vertigo	Ear and labyrinth disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Cushingoid	Endocrine disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Endocrine disorder	Endocrine disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hyperthyroidism	Endocrine disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Hypothyroidism	Endocrine disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk EG0021 affected20 at risk EG003
Blepharitis	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Diplopia	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dry eye	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Eyelid ptosis	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Night blindness	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Optic nerve disorder	Eye disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk EG0020 affected20 at risk EG003
Vision blurred	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Visual field defect	Eye disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Visual impairment	Eye disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Abdominal distension	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Abdominal pain	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Anal incontinence	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Cheilitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Constipation	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected10 at risk EG0024 affected20 at risk EG003
Diarrhoea	Gastrointestinal disorders	27.0	Systematic Assessment	EG0007 affected10 at risk EG0012 affected10 at risk EG0027 affected20 at risk EG003
Dyspepsia	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Dysphagia	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Nausea	Gastrointestinal disorders	27.0	Systematic Assessment	EG0003 affected10 at risk EG0013 affected10 at risk EG0026 affected20 at risk EG003
Stomatitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Toothache	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Vomiting	Gastrointestinal disorders	27.0	Systematic Assessment	EG0004 affected10 at risk EG0012 affected10 at risk EG0024 affected20 at risk EG003
Asthenia	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Chest discomfort	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Chills	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Face oedema	General disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fatigue	General disorders	27.0	Systematic Assessment	EG0008 affected10 at risk EG0015 affected10 at risk EG00214 affected20 at risk EG003
Gait disturbance	General disorders	27.0	Systematic Assessment	EG0003 affected10 at risk EG0012 affected10 at risk EG0026 affected20 at risk EG003
Influenza like illness	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Mucosal inflammation	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Non-cardiac chest pain	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Oedema	General disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Oedema peripheral	General disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Pain	General disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Pyrexia	General disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Candida infection	Infections and infestations	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Conjunctivitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Enterocolitis infectious	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Herpes zoster	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hordeolum	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Klebsiella infection	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Mucosal infection	Infections and infestations	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Nasopharyngitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Oral candidiasis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Pneumonia	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Rash pustular	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Sinusitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Staphylococcal infection	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Tooth infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Upper respiratory tract infection	Infections and infestations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Urinary tract infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0025 affected20 at risk EG003
Viral infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Contusion	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Fall	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0003 affected10 at risk EG0010 affected10 at risk EG0025 affected20 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Alanine aminotransferase increased	Investigations	27.0	Systematic Assessment	EG0004 affected10 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Amylase increased	Investigations	27.0	Systematic Assessment	EG0003 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Aspartate aminotransferase increased	Investigations	27.0	Systematic Assessment	EG0004 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Blood alkaline phosphatase increased	Investigations	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Blood bilirubin increased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Blood creatinine increased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Lipase increased	Investigations	27.0	Systematic Assessment	EG0004 affected10 at risk EG0012 affected10 at risk EG0022 affected20 at risk EG003
Lymphocyte count decreased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0023 affected20 at risk EG003
Neutrophil count decreased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Platelet count decreased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0023 affected20 at risk EG003
Weight decreased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Weight increased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
White blood cell count decreased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
White blood cell count increased	Investigations	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0023 affected20 at risk EG003
Dehydration	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0013 affected10 at risk EG0025 affected20 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hyperlipasaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0013 affected10 at risk EG0025 affected20 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected10 at risk EG0021 affected20 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Scoliosis	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Amnesia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Aphasia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Ataxia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Balance disorder	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Brain oedema	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Cognitive disorder	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0023 affected20 at risk EG003
Disturbance in attention	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dizziness	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0014 affected10 at risk EG0024 affected20 at risk EG003
Dysarthria	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk EG0022 affected20 at risk EG003
Dysgeusia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dyspraxia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Facial paresis	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Haemorrhage intracranial	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Headache	Nervous system disorders	27.0	Systematic Assessment	EG0007 affected10 at risk EG0017 affected10 at risk EG00210 affected20 at risk EG003
Hemiparesis	Nervous system disorders	27.0	Systematic Assessment	EG0003 affected10 at risk EG0013 affected10 at risk EG0027 affected20 at risk EG003
Hypoaesthesia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Lethargy	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0024 affected20 at risk EG003
Memory impairment	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0013 affected10 at risk EG0024 affected20 at risk EG003
Paraesthesia	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Partial seizures	Nervous system disorders	27.0	Systematic Assessment	EG0003 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Presyncope	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Psychomotor skills impaired	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Seizure	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk EG0022 affected20 at risk EG003
Syncope	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Tremor	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Vasogenic cerebral oedema	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Agitation	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Anxiety	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Confusional state	Psychiatric disorders	27.0	Systematic Assessment	EG0003 affected10 at risk EG0013 affected10 at risk EG0029 affected20 at risk EG003
Delusion	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Depression	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Disorientation	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Hallucination	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Insomnia	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Irritability	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Acute kidney injury	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Micturition urgency	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Pollakiuria	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Proteinuria	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Urinary hesitation	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Urinary incontinence	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0024 affected20 at risk EG003
Urinary retention	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0003 affected10 at risk EG0011 affected10 at risk EG0029 affected20 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0002 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0022 affected20 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0011 affected10 at risk EG0024 affected20 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Tonsillar erythema	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0020 affected20 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0003 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0012 affected10 at risk EG0026 affected20 at risk EG003
Rash	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0012 affected10 at risk EG0025 affected20 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0004 affected10 at risk EG0010 affected10 at risk EG0022 affected20 at risk EG003
Deep vein thrombosis	Vascular disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0011 affected10 at risk EG0021 affected20 at risk EG003
Hypertension	Vascular disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Hypotension	Vascular disorders	27.0	Systematic Assessment	EG0000 affected10 at risk EG0010 affected10 at risk EG0021 affected20 at risk EG003
Pelvic venous thrombosis	Vascular disorders	27.0	Systematic Assessment	EG0001 affected10 at risk EG0010 affected10 at risk EG0020 affected20 at risk EG003

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue

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	Term
D000077594	Nivolumab
D000068258	Bevacizumab
D000074324	Ipilimumab