An Investigational Immuno-therapy Study of Temozolomide P... | NCT02667587

NCT02667587

ID	Type	Description	Link
2015-004722-34	EudraCT Number

Status Module

Name	Class
Ono Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivolumab + Temozolomide + Radiotherapy	Experimental	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	Drug: Nivolumab Drug: Temozolomide Radiation: Radiotherapy
Nivolumab placebo + Temozolomide + Radiotherapy	Placebo Comparator	Nivolumab Placebo: specified dose on specified days; IV infusion Temozolomide: 75 mg/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units 5x/week x 6 weeks	Drug: Temozolomide Radiation: Radiotherapy Other: Nivolumab Placebo

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug		Nivolumab + Temozolomide + Radiotherapy	Opdivo Nivo N BMS-936558

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Determined by BICR	The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.	From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)
Overall Survival (OS)	The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.	From randomization to date of death (up to approximately 4.5 years)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) Rates at 12 Months	Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months	From randomization to 12 months after first dose
Overall Survival (OS) Rates at 24 Months

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0023		Birmingham	Alabama	35294-3410	United States
Local Institution - 0003

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35511454	Derived	Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro Oncol. 2022 Nov 2;24(11):1935-1949. doi: 10.1093/neuonc/noac116.
32691060

Label	URL
BMS Clinical Trial Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Radiotherapy, Temozolomide Plus Nivolumab	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Nivolumab: 240 mg administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by nivolumab 480 mg as a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 2, 2021	Nov 30, 2021

Arm/Group Information

ID	Title	Description
BG000	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
BG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00057.9± 12.2 BG00158.7± 11.4 BG00258.3± 11.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000153 BG001161 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0007 BG00111 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000301 BG001318 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

Progression-free Survival (PFS) Determined by BICR

The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

ID	Title	Description
OG000	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
OG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Units	Counts
Participants	OG000358 OG001358

Title

Denominators

Categories

Title	Measurements
	OG00010.64(8.90 to 11.79) OG00110.32(9.69 to 12.45)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000						Cox Proportional Hazard	1.06			2-Sided	95	0.90	1.25					Superiority

Primary

Overall Survival (OS)

The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to date of death (up to approximately 4.5 years)

ID	Title	Description
OG000	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
OG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Secondary

Overall Survival (OS) Rates at 12 Months

Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months

All randomized participants

Posted

Number

95% Confidence Interval

percentage of participants

From randomization to 12 months after first dose

ID	Title	Description
OG000	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
OG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Secondary

Overall Survival (OS) Rates at 24 Months

Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months

All randomized participants

Posted

Number

95% Confidence Interval

percentage of participants

From randomization to 24 months after first dose

ID	Title	Description
OG000	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
OG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Secondary

Progression Free Survival (PFS) Based on Investigator Assessment

The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by investigator assessment based Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmation of progressive disease.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)

ID	Title	Description
OG000	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
OG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Post-Hoc

Progression-free Survival (PFS) Determined by BICR - Extended Collection

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 82 Months)

ID	Title	Description
OG000	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
OG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

Post-Hoc

Overall Survival (OS) - Extended Collection

All randomized participants with no baseline corticosteroids

Posted

Median

95% Confidence Interval

Months

From randomization to date of death (up to approximately 82 Months)

ID	Title	Description
OG000	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks
OG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.

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	Radiotherapy, Temozolomide Plus Nivolumab	Nivolumab: specified dose on specified days; IV (intravenous) infusion Temozolomide: 75 mg (milligram)/meter squared daily during Radiotherapy, 4 week treatment break, 150 mg/meter squared Day 1-5 for Cycle 1 and increased to 200 mg/meter squared Day 1-5 for Cycle2-Cycle 6 as tolerated; orally (additional cycles may be permitted with approval of sponsor) Radiotherapy: 2 gray units (joule of radiation energy per kilogram) 5 times per week for 6 weeks	263	358	259	355	351	355
EG001	Radiotherapy, Temozolomide Plus Placebo	Radiotherapy: A total dose of 60 Gy [Gray (radiotherapy dose)], in 2 Gy daily fractions on 5 days/week, will be administered in 6 weeks (30 fractions). Placebo: administered intravenously (IV) as a 30 minute infusion every 2 weeks for 8 doses followed by a 30 minute infusion every 4 weeks beginning after 8 doses Temozolomide: 75 mg/m2 orally daily during radiation therapy followed by 4 week break then 6 (28-day) cycles temozolomide on Days 1-5 at 150 mg/m2 in Cycle 1 increasing to 200 mg/m2 as tolerated up to 6 cycles.	255	358	217	354	343	354

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0010 affected354 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Febrile neutropenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0012 affected354 at risk
Haemolysis	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Leukopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Lymphopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Microcytic anaemia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Neutropenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0006 affected355 at risk EG0011 affected354 at risk
Pancytopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0008 affected355 at risk EG0012 affected354 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0007 affected355 at risk EG0017 affected354 at risk
Acute myocardial infarction	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Angina pectoris	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Atrial fibrillation	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Atrial flutter	Cardiac disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Atrial tachycardia	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Bundle branch block right	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Cardiac arrest	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Cardiac failure	Cardiac disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Cardiac failure congestive	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Left ventricular failure	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Myocardial infarction	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Myocarditis	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Pericarditis	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Sinus tachycardia	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Stress cardiomyopathy	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Supraventricular tachycardia	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Ventricular tachycardia	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Branchial cyst	Congenital, familial and genetic disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Vertigo	Ear and labyrinth disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Adrenal insufficiency	Endocrine disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0012 affected354 at risk
Diabetes insipidus	Endocrine disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Hypothyroidism	Endocrine disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0010 affected354 at risk
Cataract	Eye disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Diplopia	Eye disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Eye swelling	Eye disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Eyelid ptosis	Eye disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Iridocyclitis	Eye disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Retinal detachment	Eye disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Vision blurred	Eye disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Abdominal pain	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Abdominal pain upper	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Autoimmune colitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Colitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0005 affected355 at risk EG0010 affected354 at risk
Constipation	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Diarrhoea	Gastrointestinal disorders	27.0	Systematic Assessment	EG0004 affected355 at risk EG0011 affected354 at risk
Diverticular perforation	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Dysphagia	Gastrointestinal disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Enterocolitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Gastritis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Intestinal obstruction	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Large intestinal obstruction	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Nausea	Gastrointestinal disorders	27.0	Systematic Assessment	EG0004 affected355 at risk EG0011 affected354 at risk
Oesophagitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Vomiting	Gastrointestinal disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0013 affected354 at risk
Asthenia	General disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0013 affected354 at risk
Cyst	General disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Death	General disorders	27.0	Systematic Assessment	EG0004 affected355 at risk EG0013 affected354 at risk
Drowning	General disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Fatigue	General disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Gait disturbance	General disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Gait inability	General disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
General physical health deterioration	General disorders	27.0	Systematic Assessment	EG0008 affected355 at risk EG0014 affected354 at risk
Hyperthermia	General disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Influenza like illness	General disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Localised oedema	General disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Malaise	General disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Non-cardiac chest pain	General disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Oedema peripheral	General disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Pyrexia	General disorders	27.0	Systematic Assessment	EG00016 affected355 at risk EG0014 affected354 at risk
Sudden death	General disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0013 affected354 at risk
Systemic inflammatory response syndrome	General disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Autoimmune hepatitis	Hepatobiliary disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0010 affected354 at risk
Cholecystitis	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Cholelithiasis	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Drug-induced liver injury	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Haemorrhagic hepatic cyst	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Hepatic cytolysis	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Hepatic function abnormal	Hepatobiliary disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Hepatitis	Hepatobiliary disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0010 affected354 at risk
Hepatitis acute	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Hepatotoxicity	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Liver disorder	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Drug hypersensitivity	Immune system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Hypersensitivity	Immune system disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0011 affected354 at risk
Immunodeficiency	Immune system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Abscess limb	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Appendicitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0012 affected354 at risk
Bacterial infection	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
COVID-19	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Cellulitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Cystitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Device related infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Diverticulitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Encephalitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0012 affected354 at risk
Gastrointestinal infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Herpes simplex	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Herpes zoster	Infections and infestations	27.0	Systematic Assessment	EG0005 affected355 at risk EG0011 affected354 at risk
Influenza	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0012 affected354 at risk
Intervertebral discitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Meningitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Meningitis aseptic	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Meningitis viral	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Parotitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Pneumonia	Infections and infestations	27.0	Systematic Assessment	EG00014 affected355 at risk EG0015 affected354 at risk
Pneumonia aspiration	Infections and infestations	27.0	Systematic Assessment	EG0004 affected355 at risk EG0011 affected354 at risk
Pneumonia viral	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Post procedural infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Postoperative wound infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0012 affected354 at risk
Pulmonary sepsis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Pyometra	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Respiratory tract infection	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Rhinitis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Sepsis	Infections and infestations	27.0	Systematic Assessment	EG0004 affected355 at risk EG0011 affected354 at risk
Septic shock	Infections and infestations	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Sinusitis	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Staphylococcal bacteraemia	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Upper respiratory tract infection	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Urinary tract infection	Infections and infestations	27.0	Systematic Assessment	EG0007 affected355 at risk EG0014 affected354 at risk
Urosepsis	Infections and infestations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Wound infection	Infections and infestations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Accidental overdose	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Compression fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0012 affected354 at risk
Fall	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0003 affected355 at risk EG0012 affected354 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Femur fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Foot fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Foreign body	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Hip fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Incision site swelling	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Overdose	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Post procedural complication	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Radiation necrosis	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Radiation skin injury	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Spinal fracture	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0002 affected355 at risk EG0012 affected354 at risk
Subdural haematoma	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0012 affected354 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Wound complication	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Wound dehiscence	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected355 at risk EG0012 affected354 at risk
Alanine aminotransferase increased	Investigations	27.0	Systematic Assessment	EG0003 affected355 at risk EG0011 affected354 at risk
Aspartate aminotransferase increased	Investigations	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Blood bilirubin increased	Investigations	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Influenza A virus test positive	Investigations	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Neutrophil count decreased	Investigations	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Platelet count decreased	Investigations	27.0	Systematic Assessment	EG0006 affected355 at risk EG0013 affected354 at risk
White blood cell count decreased	Investigations	27.0	Systematic Assessment	EG0004 affected355 at risk EG0011 affected354 at risk
Adult failure to thrive	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Decreased appetite	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Dehydration	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0014 affected354 at risk
Diabetes mellitus	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Failure to thrive	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Hyponatraemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Ankylosing spondylitis	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Arthritis	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Autoimmune myositis	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Eosinophilic fasciitis	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0013 affected354 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Chronic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0007 affected355 at risk EG00112 affected354 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG00075 affected355 at risk EG00173 affected354 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected355 at risk EG0012 affected354 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0006 affected355 at risk EG00111 affected354 at risk
Neoplasm recurrence	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Peritumoural oedema	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Recurrent cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Tumour flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG00010 affected355 at risk EG0017 affected354 at risk
Tumour pseudoprogression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Acute disseminated encephalomyelitis	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Altered state of consciousness	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Aphasia	Nervous system disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0015 affected354 at risk
Brain oedema	Nervous system disorders	27.0	Systematic Assessment	EG0008 affected355 at risk EG0017 affected354 at risk
Central nervous system lesion	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Central nervous system necrosis	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Cerebral cyst	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Cerebral haemorrhage	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Cerebral infarction	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0013 affected354 at risk
Cerebral ischaemia	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0013 affected354 at risk
Cerebral venous sinus thrombosis	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Cerebrospinal fluid leakage	Nervous system disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0011 affected354 at risk
Cerebrovascular accident	Nervous system disorders	27.0	Systematic Assessment	EG0004 affected355 at risk EG0012 affected354 at risk
Change in seizure presentation	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Cognitive disorder	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0016 affected354 at risk
Coma	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Depressed level of consciousness	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Dizziness	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0014 affected354 at risk
Drooling	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Dysarthria	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Encephalopathy	Nervous system disorders	27.0	Systematic Assessment	EG0004 affected355 at risk EG0015 affected354 at risk
Epilepsy	Nervous system disorders	27.0	Systematic Assessment	EG00015 affected355 at risk EG00112 affected354 at risk
Generalised tonic-clonic seizure	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Haemorrhage intracranial	Nervous system disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0012 affected354 at risk
Headache	Nervous system disorders	27.0	Systematic Assessment	EG0008 affected355 at risk EG0016 affected354 at risk
Hemiparesis	Nervous system disorders	27.0	Systematic Assessment	EG0007 affected355 at risk EG0019 affected354 at risk
Hemiplegia	Nervous system disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0010 affected354 at risk
Hydrocephalus	Nervous system disorders	27.0	Systematic Assessment	EG00010 affected355 at risk EG0019 affected354 at risk
Intracranial pressure increased	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0013 affected354 at risk
Ischaemic stroke	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Lacunar infarction	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Lethargy	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Muscle contractions involuntary	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Nervous system disorder	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0012 affected354 at risk
Neurological decompensation	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0012 affected354 at risk
Neurological symptom	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Neuropathy peripheral	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Optic neuritis	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Partial seizures	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Psychomotor skills impaired	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Radiculopathy	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Seizure	Nervous system disorders	27.0	Systematic Assessment	EG00048 affected355 at risk EG00140 affected354 at risk
Simple partial seizures	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Somnolence	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Status epilepticus	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Subdural hygroma	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Syncope	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Vasogenic cerebral oedema	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0012 affected354 at risk
Device malfunction	Product Issues	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Agitation	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Confusional state	Psychiatric disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0012 affected354 at risk
Delirium	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Depression	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Mental status changes	Psychiatric disorders	27.0	Systematic Assessment	EG0005 affected355 at risk EG0010 affected354 at risk
Mood altered	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Paranoia	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Suicidal ideation	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Acute kidney injury	Renal and urinary disorders	27.0	Systematic Assessment	EG0004 affected355 at risk EG0012 affected354 at risk
Bladder stenosis	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Haematuria	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Nephritis	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Nephrolithiasis	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Nephropathy	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Renal failure	Renal and urinary disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Urinary retention	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Cystocele	Reproductive system and breast disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0013 affected354 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Laryngeal obstruction	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0003 affected355 at risk EG0011 affected354 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0009 affected355 at risk EG00113 affected354 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0011 affected354 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Drug eruption	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Rash	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0012 affected354 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0012 affected354 at risk
Scar pain	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Skin reaction	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Assisted suicide	Surgical and medical procedures	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Cholecystectomy	Surgical and medical procedures	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Euthanasia	Surgical and medical procedures	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Axillary vein thrombosis	Vascular disorders	27.0	Systematic Assessment	EG0000 affected355 at risk EG0011 affected354 at risk
Deep vein thrombosis	Vascular disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0012 affected354 at risk
Embolism	Vascular disorders	27.0	Systematic Assessment	EG0005 affected355 at risk EG0015 affected354 at risk
Hypotension	Vascular disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0011 affected354 at risk
Orthostatic hypotension	Vascular disorders	27.0	Systematic Assessment	EG0001 affected355 at risk EG0010 affected354 at risk
Thrombosis	Vascular disorders	27.0	Systematic Assessment	EG0002 affected355 at risk EG0010 affected354 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG00042 affected355 at risk EG00126 affected354 at risk
Leukopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG00020 affected355 at risk EG00130 affected354 at risk
Lymphopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG00043 affected355 at risk EG00139 affected354 at risk
Neutropenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG00033 affected355 at risk EG00132 affected354 at risk
Thrombocytopenia	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG00069 affected355 at risk EG00167 affected354 at risk
Hypothyroidism	Endocrine disorders	27.0	Systematic Assessment	EG00028 affected355 at risk EG0019 affected354 at risk
Dry eye	Eye disorders	27.0	Systematic Assessment	EG00018 affected355 at risk EG00115 affected354 at risk
Vision blurred	Eye disorders	27.0	Systematic Assessment	EG00030 affected355 at risk EG00123 affected354 at risk
Abdominal pain	Gastrointestinal disorders	27.0	Systematic Assessment	EG00032 affected355 at risk EG00127 affected354 at risk
Constipation	Gastrointestinal disorders	27.0	Systematic Assessment	EG000163 affected355 at risk EG001145 affected354 at risk
Diarrhoea	Gastrointestinal disorders	27.0	Systematic Assessment	EG00077 affected355 at risk EG00172 affected354 at risk
Nausea	Gastrointestinal disorders	27.0	Systematic Assessment	EG000187 affected355 at risk EG001159 affected354 at risk
Stomatitis	Gastrointestinal disorders	27.0	Systematic Assessment	EG00025 affected355 at risk EG0019 affected354 at risk
Vomiting	Gastrointestinal disorders	27.0	Systematic Assessment	EG00090 affected355 at risk EG00175 affected354 at risk
Asthenia	General disorders	27.0	Systematic Assessment	EG00042 affected355 at risk EG00140 affected354 at risk
Chills	General disorders	27.0	Systematic Assessment	EG00025 affected355 at risk EG00113 affected354 at risk
Fatigue	General disorders	27.0	Systematic Assessment	EG000186 affected355 at risk EG001176 affected354 at risk
Gait disturbance	General disorders	27.0	Systematic Assessment	EG00029 affected355 at risk EG00134 affected354 at risk
Malaise	General disorders	27.0	Systematic Assessment	EG00017 affected355 at risk EG00118 affected354 at risk
Oedema peripheral	General disorders	27.0	Systematic Assessment	EG00030 affected355 at risk EG00128 affected354 at risk
Pain	General disorders	27.0	Systematic Assessment	EG00018 affected355 at risk EG0019 affected354 at risk
Pyrexia	General disorders	27.0	Systematic Assessment	EG00070 affected355 at risk EG00131 affected354 at risk
Conjunctivitis	Infections and infestations	27.0	Systematic Assessment	EG00020 affected355 at risk EG00112 affected354 at risk
Nasopharyngitis	Infections and infestations	27.0	Systematic Assessment	EG00037 affected355 at risk EG00131 affected354 at risk
Oral candidiasis	Infections and infestations	27.0	Systematic Assessment	EG00020 affected355 at risk EG00112 affected354 at risk
Upper respiratory tract infection	Infections and infestations	27.0	Systematic Assessment	EG00021 affected355 at risk EG00119 affected354 at risk
Urinary tract infection	Infections and infestations	27.0	Systematic Assessment	EG00045 affected355 at risk EG00134 affected354 at risk
Fall	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG00037 affected355 at risk EG00146 affected354 at risk
Radiation skin injury	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG00035 affected355 at risk EG00138 affected354 at risk
Alanine aminotransferase increased	Investigations	27.0	Systematic Assessment	EG00063 affected355 at risk EG00139 affected354 at risk
Aspartate aminotransferase increased	Investigations	27.0	Systematic Assessment	EG00046 affected355 at risk EG00116 affected354 at risk
Blood creatinine increased	Investigations	27.0	Systematic Assessment	EG00023 affected355 at risk EG00114 affected354 at risk
Lymphocyte count decreased	Investigations	27.0	Systematic Assessment	EG00067 affected355 at risk EG00162 affected354 at risk
Neutrophil count decreased	Investigations	27.0	Systematic Assessment	EG00034 affected355 at risk EG00140 affected354 at risk
Platelet count decreased	Investigations	27.0	Systematic Assessment	EG00075 affected355 at risk EG00175 affected354 at risk
Weight decreased	Investigations	27.0	Systematic Assessment	EG00050 affected355 at risk EG00133 affected354 at risk
Weight increased	Investigations	27.0	Systematic Assessment	EG00013 affected355 at risk EG00121 affected354 at risk
White blood cell count decreased	Investigations	27.0	Systematic Assessment	EG00040 affected355 at risk EG00144 affected354 at risk
Decreased appetite	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG00097 affected355 at risk EG00187 affected354 at risk
Hyperglycaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG00025 affected355 at risk EG00134 affected354 at risk
Hypokalaemia	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG00034 affected355 at risk EG00115 affected354 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00061 affected355 at risk EG00153 affected354 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00041 affected355 at risk EG00134 affected354 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00035 affected355 at risk EG00128 affected354 at risk
Myalgia	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00030 affected355 at risk EG00115 affected354 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00028 affected355 at risk EG00116 affected354 at risk
Aphasia	Nervous system disorders	27.0	Systematic Assessment	EG00030 affected355 at risk EG00132 affected354 at risk
Cognitive disorder	Nervous system disorders	27.0	Systematic Assessment	EG00019 affected355 at risk EG00119 affected354 at risk
Dizziness	Nervous system disorders	27.0	Systematic Assessment	EG00047 affected355 at risk EG00153 affected354 at risk
Dysgeusia	Nervous system disorders	27.0	Systematic Assessment	EG00036 affected355 at risk EG00127 affected354 at risk
Headache	Nervous system disorders	27.0	Systematic Assessment	EG000142 affected355 at risk EG001135 affected354 at risk
Hemiparesis	Nervous system disorders	27.0	Systematic Assessment	EG00023 affected355 at risk EG00125 affected354 at risk
Memory impairment	Nervous system disorders	27.0	Systematic Assessment	EG00026 affected355 at risk EG00136 affected354 at risk
Paraesthesia	Nervous system disorders	27.0	Systematic Assessment	EG00026 affected355 at risk EG00123 affected354 at risk
Seizure	Nervous system disorders	27.0	Systematic Assessment	EG00063 affected355 at risk EG00176 affected354 at risk
Tremor	Nervous system disorders	27.0	Systematic Assessment	EG00022 affected355 at risk EG00126 affected354 at risk
Anxiety	Psychiatric disorders	27.0	Systematic Assessment	EG00032 affected355 at risk EG00134 affected354 at risk
Confusional state	Psychiatric disorders	27.0	Systematic Assessment	EG00020 affected355 at risk EG00121 affected354 at risk
Depression	Psychiatric disorders	27.0	Systematic Assessment	EG00030 affected355 at risk EG00134 affected354 at risk
Insomnia	Psychiatric disorders	27.0	Systematic Assessment	EG00054 affected355 at risk EG00147 affected354 at risk
Pollakiuria	Renal and urinary disorders	27.0	Systematic Assessment	EG00018 affected355 at risk EG00113 affected354 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG00059 affected355 at risk EG00151 affected354 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG00027 affected355 at risk EG00120 affected354 at risk
Alopecia	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG000115 affected355 at risk EG001109 affected354 at risk
Dry skin	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00024 affected355 at risk EG00127 affected354 at risk
Erythema	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00029 affected355 at risk EG00122 affected354 at risk
Pruritus	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00086 affected355 at risk EG00177 affected354 at risk
Rash	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00085 affected355 at risk EG00158 affected354 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00032 affected355 at risk EG00113 affected354 at risk
Hypertension	Vascular disorders	27.0	Systematic Assessment	EG00029 affected355 at risk EG00132 affected354 at risk

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013812	Therapeutics

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000077594	Nivolumab
D000077204	Temozolomide
D011878	Radiotherapy