Study of MEDI4736 Monotherapy and in Combination With Tre... | NCT02369874

NCT02369874

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MEDI4736	Experimental	MEDI4736 monotherapy	Drug: MEDI4736
MEDI4736 + Tremelimumab	Experimental	MEDI4736 + tremelimumab combination therapy	Drug: MEDI4736 + Tremelimumab
Standard of Care	Active Comparator	Standard of Care	Drug: Standard of Care

Name	Type	Description	Arm Group Labels	Other Names
MEDI4736	Drug	MEDI4736 Monotherapy	MEDI4736
MEDI4736 + Tremelimumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization until death due to any cause. OS was analyzed for the full analysis set, regardless of programmed death-ligand 1 (PD-L1) status.	September 2015 to September 2018 (36 months)

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in PD-L1 Negative Participants	OS is defined as the time from the date of randomization until death due to any cause. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.	September 2015 to September 2018 (36 months)
Overall Survival (OS) in PD-L1 Positive Participants

Eligibility Module

Eligibility Criteria

Inclusion Criteria: - Age ≥18 years; - Written informed consent obtained from the patient/legal representative; - Histologically or cytologically confirmed recurrent or metastatic SCCHN; - Tumor progression or recurrence during or after only one palliative systemic treatment regimen for recurrent or metastatic disease that must have contained a platinum agent OR progression within 6 months of the last dose of platinum given as part of multimodality therapy with curative intent; - Confirmed PD-L1-positive or -negative SCCHN by the Ventana PD-L1 SP263 IHC assay; - WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; At least 1 measurable lesion, - Not previously irradiated; - No prior exposure to immune-mediated therapy; - Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Exclusion Criteria: - Histologically or cytologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck; - Received more than 1 palliative systemic regimen for recurrent or metastatic disease; -Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment; - Receipt of any investigational anticancer therapy within 28 days or 5 half-lives; - Receipt of last dose of an approved (marketed) anticancer therapy (chemotherapy, targeted therapy, biologic therapy, mAbs, etc) within 21 days prior to the first dose of study treatment; - Major surgical procedure within 28 days prior to the first dose of Investigational Product; - Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criterion; - Current or prior use of immunosuppressive medication within 14 days before the first dose of their assigned Investigational Product; - History of allogeneic organ transplantation; - Active or prior documented autoimmune or inflammatory disorders; - Uncontrolled intercurrent illness; - Patients with a history of brain metastases, spinal cord compression, or leptomeningeal carcinomatosis; - Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction; - History of active primary immunodeficiency; - Active tuberculosis; - Active infection including hepatitis B, hepatitis C or human immunodeficiency virus (HIV); - Receipt of live, attenuated vaccine within 30 days prior to the first dose of Investigational Product; - Pregnant or breast-feeding female patients; - Known allergy or hypersensitivity to Investigational Product

Name	Affiliation	Role
Nassim Morsli, MD	Medical Director AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Tucson	Arizona	85711	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32294530	Derived	Ferris RL, Haddad R, Even C, Tahara M, Dvorkin M, Ciuleanu TE, Clement PM, Mesia R, Kutukova S, Zholudeva L, Daste A, Caballero-Daroqui J, Keam B, Vynnychenko I, Lafond C, Shetty J, Mann H, Fan J, Wildsmith S, Morsli N, Fayette J, Licitra L. Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study. Ann Oncol. 2020 Jul;31(7):942-950. doi: 10.1016/j.annonc.2020.04.001. Epub 2020 Apr 12.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).

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
SAP	No	Yes	No	Statistical Analysis Plan	Jan 18, 2018	Sep 10, 2019

Arm/Group Information

ID	Title	Description
BG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
BG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
BG002	Standard of Care (SoC)	Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00059.9± 9.14 BG00159.0± 10.07 BG00259.5± 10.37 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 65 Years	BG000174 BG001169 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00038 BG00138 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00016 BG00115 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG00033 BG00135 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

Overall Survival (OS)

OS is defined as the time from the date of randomization until death due to any cause. OS was analyzed for the full analysis set, regardless of programmed death-ligand 1 (PD-L1) status.

Full analysis set - inclusive of all randomized participants.

Posted

Median

95% Confidence Interval

Months

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)	Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.

Units	Counts
Participants	OG000247 OG001240 OG002249

Title

Denominators

Categories

Title	Measurements
	OG0006.5(5.5 to 8.2) OG0017.6(6.1 to 9.8) OG0028.3(7.3 to 9.2)

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 OG002		Log Rank		0.7624		Hazard Ratio (HR)	1.04			2-Sided	95	0.85	1.26					Superiority
OG001 OG002		Log Rank		0.1993

Secondary

Overall Survival (OS) in PD-L1 Negative Participants

OS is defined as the time from the date of randomization until death due to any cause. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.

PD-L1-negative analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-negative as defined by the Ventana PD-L1 SP263 IHC assay.

Posted

Median

95% Confidence Interval

Months

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)	Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.

Secondary

Overall Survival (OS) in PD-L1 Positive Participants

OS is defined as the time from the date of randomization until death due to any cause. PD-L1 positive was defined as ≥25% of tumor cells with membrane staining for PD-L1 at any intensity.

PD-L1-positive analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-positive as defined by the Ventana PD-L1 SP263 IHC assay.

Posted

Median

95% Confidence Interval

Months

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)	Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.

Secondary

Progression Free Survival (PFS)

PFS was defined as the time from the date of randomization until the date of objective disease progression or death based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Full analysis set - inclusive of all randomized participants.

Posted

Median

95% Confidence Interval

Months

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)

Secondary

Objective Response Rate (ORR)

The percentage of participants who experienced an objective response (complete response [CR] or partial response [PR]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.

Full analysis set - inclusive of all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Assessed at randomization and every 8 weeks thereafter

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)

Secondary

Duration of Response (DoR)

Median DoR, in months, based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A complete response was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A partial response was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.

Full analysis set, participants with objective response - inclusive of all randomized participants with an objective response (RECIST 1.1).

Posted

Median

Inter-Quartile Range

Months

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)

Secondary

Disease Control Rate (DCR)

6 Months: The percentage of participants who had a best objective response of complete response (CR) or partial response (PR) in the first 6 months or had demonstrated stable disease (SD) for a minimum interval of 24 weeks following randomization.

12 Months: The percentage of participants who had a best objective response of CR or PR within 12 months or had demonstrated SD for a minimum interval of 48 weeks following randomization.

Objective response was based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.

Full analysis set - inclusive of all randomized participants.

Posted

Number

Percentage of participants

Baseline up to 6 months; baseline up to 12 months

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab

Secondary

Percentage of Participants Alive and Progression Free (APF)

APF is defined as the percentage of participants who are alive and progression free at 6 months and 12 months after randomization. Estimates of progression free survival were based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Full analysis set - inclusive of all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline up to 6 months; baseline up to 12 months

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).

Secondary

Percentage of Participants Alive

Percentage of participants alive at 12, 18 and 24 months using a Kaplan Meier estimate.

Full analysis set - inclusive of all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

12, 18 and 24 months

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)	Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.

Secondary

Progression Free Survival (PFS) in PD-L1 Negative Participants

Number of participants with confirmed objective disease progression (PD) at the time of the participant's last evaluable response evaluation criteria in solid tumors 1.1 (RECIST1.1) assessment. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.

PD-L1-negative analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-negative as defined by the Ventana PD-L1 SP263 IHC assay.

Posted

Count of Participants

Participants

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).

Secondary

Objective Response Rate (ORR) in PD-L1 Negative Participants

The percentage of PD-L1 negative participants who experienced an objective response (complete response [CR] or partial response [PR]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.

PD-L1-negative analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-negative as defined by the Ventana PD-L1 SP263 IHC assay.

Posted

Number

95% Confidence Interval

Percentage of participants

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).

Secondary

Time to Deterioration in European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire, Version 3 (EORTC QLQ-C30)

The EORTC QLQ-C30 consists of 30 questions that can be combined to produce functional scales (e.g. physical), symptom scales (e.g. fatigue), and a global measure of health status. Each of the scales are measured from 0 to 100. Deterioration was defined as a 10-point decrease from baseline in a functioning or global health status/ quality of life score or a 10-point increase from baseline in a symptom score.

All randomized patients who provided questionnaire data

Posted

Median

95% Confidence Interval

Months

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)

Secondary

Time to Deterioration for European Organisation for Research and Treatment of Cancer 35-item Head and Neck Quality of Life Questionnaire (EORTC QLQ-H&N35)

The EORTC QLQ-H&N35 comprises of 35 questions to assess head and neck cancer symptoms (e.g. pain, swallowing). Deterioration was defined as a 10-point increase from baseline in the symptom score.

All randomized patients who provided questionnaire data

Posted

Median

95% Confidence Interval

Months

September 2015 to September 2018 (36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)	Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.

Secondary

Number of Participants Reporting One or More Adverse Events (AE)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Inclusive of AEs and serious AEs.

Safety analysis set - inclusive of all participants that received at least 1 dose of study treatment.

Posted

Count of Participants

Participants

First dose to last dose + 90 days or data cut off (up to 36 months)

ID	Title	Description
OG000	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).
OG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).
OG002	Standard of Care (SoC)	Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.

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	Durvalumab + Tremelimumab	Participants received 20 mg/kg durvalumab and 1 mg/kg tremelimumab combination therapy via intravenous (IV) infusion every 4 weeks (q4w) for up to 16 weeks. 4 weeks after completion of combination therapy, participants received dosing with durvalumab 10 mg/kg monotherapy every 2 weeks (q2w) until disease progression (PD).	206	247	79	246	203	246
EG001	Durvalumab	Participants received 10 mg/kg durvalumab via intravenous (IV) infusion every 2 weeks (q2w) until disease progression (PD).	186	240	69	237	180	237
EG002	Standard of Care (SoC)	Participants received monotherapy with 1 of the following therapies at the investigator's discretion until disease progression (PD): cetuximab, a taxane, methotrexate, or a fluoropyrimidine.	199	249	61	240	207	240

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Left ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected237 at risk EG0020 events0 affected240 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Oesophageal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Staphylococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Stoma site infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected237 at risk EG0020 events0 affected240 at risk
Abdominal wall wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Osteoradionecrosis	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Loss of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events1 affected237 at risk EG0020 events0 affected240 at risk
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events1 affected237 at risk EG0020 events0 affected240 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Acquired tracheo-oesophageal fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0022 events2 affected240 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Hypopituitarism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Eye pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Coeliac disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Gastric fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Tongue haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0012 events2 affected237 at risk EG0022 events2 affected240 at risk
Facial pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0014 events4 affected237 at risk EG0021 events1 affected240 at risk
Hyperthermia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0012 events2 affected237 at risk EG0022 events2 affected240 at risk
Sudden cardiac death	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Abscess neck	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Abscess oral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Device related infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Endocarditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Escherichia sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0023 events2 affected240 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected237 at risk EG0022 events2 affected240 at risk
Peritonitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected246 at risk EG0019 events8 affected237 at risk EG0029 events9 affected240 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0010 events0 affected237 at risk EG0024 events4 affected240 at risk
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Gastrostomy tube site complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Petroleum distillate poisoning	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Tracheostomy malfunction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
White blood cell count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0022 events2 affected240 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0014 events4 affected237 at risk EG0023 events2 affected240 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0015 events2 affected237 at risk EG0021 events1 affected240 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected237 at risk EG0020 events0 affected240 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected237 at risk EG0020 events0 affected240 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected246 at risk EG0014 events4 affected237 at risk EG0022 events2 affected240 at risk
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Carotid artery disease	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0022 events1 affected240 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Epilepsy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Horner's syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected237 at risk EG0021 events1 affected240 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Device dislocation	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Device occlusion	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0022 events2 affected240 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Disorientation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Hallucinations, mixed	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0013 events3 affected237 at risk EG0023 events3 affected240 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0013 events3 affected237 at risk EG0020 events0 affected240 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0013 events3 affected237 at risk EG0020 events0 affected240 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0016 events5 affected237 at risk EG0022 events2 affected240 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0013 events3 affected237 at risk EG0021 events1 affected240 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0022 events1 affected240 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected237 at risk EG0023 events3 affected240 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0022 events1 affected240 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG0021 events1 affected240 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk
Vasculitic ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Haemorrhage	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0021 events1 affected240 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected237 at risk EG0020 events0 affected240 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected237 at risk EG0020 events0 affected240 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00068 events55 affected246 at risk EG00157 events47 affected237 at risk EG00294 events56 affected240 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected246 at risk EG00110 events8 affected237 at risk EG00225 events20 affected240 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00019 events10 affected246 at risk EG0013 events2 affected237 at risk EG00242 events13 affected240 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00016 events11 affected246 at risk EG0014 events4 affected237 at risk EG00286 events32 affected240 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00023 events11 affected246 at risk EG00111 events5 affected237 at risk EG00249 events18 affected240 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG00033 events32 affected246 at risk EG00144 events33 affected237 at risk EG0025 events5 affected240 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00037 events33 affected246 at risk EG00140 events33 affected237 at risk EG00229 events29 affected240 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00050 events38 affected246 at risk EG00146 events24 affected237 at risk EG00242 events32 affected240 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00022 events20 affected246 at risk EG00130 events28 affected237 at risk EG00218 events18 affected240 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00036 events30 affected246 at risk EG00129 events27 affected237 at risk EG00247 events41 affected240 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events5 affected246 at risk EG00112 events11 affected237 at risk EG00234 events27 affected240 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00016 events15 affected246 at risk EG00123 events18 affected237 at risk EG00224 events20 affected240 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG00057 events51 affected246 at risk EG00153 events42 affected237 at risk EG00263 events56 affected240 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00044 events40 affected246 at risk EG00135 events31 affected237 at risk EG00244 events35 affected240 at risk
Mucosal inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected246 at risk EG0013 events3 affected237 at risk EG00220 events17 affected240 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG00035 events31 affected246 at risk EG00123 events19 affected237 at risk EG00242 events29 affected240 at risk
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00020 events15 affected246 at risk EG00111 events11 affected237 at risk EG00228 events17 affected240 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00017 events15 affected246 at risk EG0018 events7 affected237 at risk EG00223 events14 affected240 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00020 events14 affected246 at risk EG00111 events7 affected237 at risk EG0029 events8 affected240 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00018 events17 affected246 at risk EG00111 events9 affected237 at risk EG00219 events12 affected240 at risk
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00027 events27 affected246 at risk EG00133 events31 affected237 at risk EG00222 events20 affected240 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00051 events44 affected246 at risk EG00133 events30 affected237 at risk EG00256 events48 affected240 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00021 events17 affected246 at risk EG00112 events10 affected237 at risk EG0028 events7 affected240 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00016 events14 affected246 at risk EG00115 events11 affected237 at risk EG0028 events8 affected240 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00020 events20 affected246 at risk EG00116 events15 affected237 at risk EG00224 events23 affected240 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected246 at risk EG00115 events13 affected237 at risk EG00219 events16 affected240 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0015 events5 affected237 at risk EG00226 events24 affected240 at risk
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00013 events13 affected246 at risk EG0017 events7 affected237 at risk EG0028 events8 affected240 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00027 events26 affected246 at risk EG00126 events25 affected237 at risk EG00222 events19 affected240 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00027 events27 affected246 at risk EG00129 events27 affected237 at risk EG00221 events19 affected240 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected237 at risk EG00230 events29 affected240 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0014 events4 affected237 at risk EG00218 events17 affected240 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00028 events23 affected246 at risk EG00113 events10 affected237 at risk EG00210 events9 affected240 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00020 events18 affected246 at risk EG00122 events19 affected237 at risk EG00238 events36 affected240 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00017 events17 affected246 at risk EG00114 events11 affected237 at risk EG0028 events7 affected240 at risk

ID	Term
D012008	Recurrence
D006258	Head and Neck Neoplasms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Term
C000613593	durvalumab
C520704	tremelimumab
D059039	Standard of Care