Phase III Open Label Study of MEDI 4736 With/Without Trem... | NCT02551159

Label	Type	Description	Intervention Names
Monotherapy	Experimental	MEDI4736 monotherapy.	Biological: MEDI4736
Combination Therapy	Experimental	MEDI4736+Tremelimumab combination therapy	Biological: Tremelimumab Biological: MEDI4736+Tremelimumab
Standard of Care	Active Comparator	Standard of Care treatment	Biological: Cetuximab Drug: 5-fluorouracil (5FU) Drug: Cisplatin Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
MEDI4736	Biological	Anti-PD-L1 antibody	Monotherapy
Tremelimumab

Measure	Description	Time Frame
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)	Number of participants with Overall Survival (OS)	From date of randomization until time of final analysis, an average of approximately 4 years
Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup	Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)	From date of randomization until time of final analysis, an average of approximately 4 years

Measure	Description	Time Frame
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)	Number of participants with Overall Survival (OS)	From date of randomization until time of final analysis, an average of approximately 4 years
Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup

Name	Affiliation	Role
Richard Olsson		Study Director
Tanguy Seiwert	The University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aurora	Colorado	80045	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
38430375	Derived	Seiwert TY, Wildsmith S, Fayette J, Harrington K, Gillison M, Ahn MJ, Takahashi S, Weiss J, Machiels JP, Baxi S, Baker V, Evans B, Morsli N, Jill Walker, Real K, L'Hernault A, Psyrri A. Outcomes in biomarker-selected subgroups from the KESTREL study of durvalumab and tremelimumab in recurrent or metastatic head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2024 Mar 2;73(4):70. doi: 10.1007/s00262-024-03643-3.
33684371

Label	URL
Related Info	View source

ID	Title	Description
FG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
FG001	Durvalumab

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 29, 2020	Jul 5, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)

Number of participants with Overall Survival (OS)

PD-L1 TC/IC subgroup

Posted

Count of Participants

Participants

From date of randomization until time of final analysis, an average of approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Units	Counts
Participants	OG000190 OG00199 OG00294

Title

Denominators

Categories

Title	Measurements
Death	OG000162 OG00184 OG00277
Voluntary Discontinuation by subject

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
OG001 OG002	Statistical analysis of number of deaths	Log Rank		0.787	2 sided	Hazard Ratio (HR)	0.96			2-Sided	95	0.69	1.32					Superiority

Primary

Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup

Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)

PD-L1 TC/IC subgroup

Posted

Median

95% Confidence Interval

Months

From date of randomization until time of final analysis, an average of approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)

Number of participants with Overall Survival (OS)

PD-L1 TC/IC subgroup

Posted

Count of Participants

Participants

From date of randomization until time of final analysis, an average of approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup

Percentage of patients alive

PD-L1 TC/IC subgroup

Posted

Number

95% Confidence Interval

% of participants

12, 18 and 24 months after randomization

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup

Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

PD-L1 TC/IC subgroup

Posted

Median

95% Confidence Interval

Months

Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup

Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: >= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)

PD-L1 TC/IC subgroup

Posted

Count of Participants

Participants

Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup

Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression

PD-L1 TC/IC subgroup

Posted

Median

95% Confidence Interval

Months

Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Overall Survival (OS) Status in the All-comers (Full Analysis Set)

Number of participants with Overall Survival (OS)

All-comers (Full analysis set)

Posted

Count of Participants

Participants

From date of randomization until time of final analysis, an average of approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)

Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)

All-comers (Full analysis set)

Posted

Median

95% Confidence Interval

Months

From date of randomization until time of final analysis, an average of approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)

Percentage of patients alive

All-comers (Full analysis set)

Posted

Number

95% Confidence Interval

% of participants

12, 18 and 24 months after randomization

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Progression Free Survival (PFS) in the All-comers (Full Analysis Set)

Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).

Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

All-comers (Full analysis set)

Posted

Median

95% Confidence Interval

Months

Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Objective Response Rate (ORR) in the All-comers (Full Analysis Set)

All-comers (Full analysis set)

Posted

Count of Participants

Participants

Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Secondary

Duration of Response (DoR) in the All-comers (Full Analysis Set)

Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression

All-comers (Full analysis set)

Posted

Median

95% Confidence Interval

Months

Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years

ID	Title	Description
OG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
OG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0023 events3 affected196 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0025 events5 affected196 at risk
Cardiac arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0010 events0 affected202 at risk EG0022 events2 affected196 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Hypopituitarism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00014 events9 affected408 at risk EG0012 events2 affected202 at risk EG0024 events4 affected196 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0012 events2 affected202 at risk EG0020 events0 affected196 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Death	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0014 events4 affected202 at risk EG0022 events2 affected196 at risk
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Mucosal inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0025 events4 affected196 at risk
Oral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Superinfection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Tracheitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Gastrostomy failure	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0022 events2 affected196 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Amylase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Troponin t increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0010 events0 affected202 at risk EG0023 events3 affected196 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected408 at risk EG0012 events1 affected202 at risk EG0022 events2 affected196 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0021 events1 affected196 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Autoimmune myositis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0023 events3 affected196 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Loss of consciousness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Device dislocation	Product Issues	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Device occlusion	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected408 at risk EG0011 events1 affected202 at risk EG0023 events3 affected196 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0013 events3 affected202 at risk EG0021 events1 affected196 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0012 events2 affected202 at risk EG0020 events0 affected196 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0022 events2 affected196 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0022 events2 affected196 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0029 events8 affected196 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0026 events4 affected196 at risk
Lymph node haemorrhage	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0025 events5 affected196 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0012 events2 affected202 at risk EG0020 events0 affected196 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Atrial flutter	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0012 events2 affected202 at risk EG0020 events0 affected196 at risk
Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected408 at risk EG0011 events1 affected202 at risk EG0025 events5 affected196 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0022 events2 affected196 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected408 at risk EG0010 events0 affected202 at risk EG0022 events2 affected196 at risk
Oral pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Proctitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Tongue oedema	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00012 events8 affected408 at risk EG0012 events1 affected202 at risk EG0022 events2 affected196 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0021 events1 affected196 at risk
Complication associated with device	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Face oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0013 events3 affected202 at risk EG0020 events0 affected196 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0013 events2 affected202 at risk EG0022 events2 affected196 at risk
General physical health deterioration	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Hyperthermia	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected408 at risk EG0013 events3 affected202 at risk EG0022 events2 affected196 at risk
Soft tissue inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Sudden death	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Hepatorenal failure	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0023 events3 affected196 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Abdominal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Abscess neck	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Acute sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Bacterial infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Bacterial sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0021 events1 affected196 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Device related infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Ear infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Fungal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Gangrene	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Herpes zoster	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected408 at risk EG0011 events1 affected202 at risk EG0022 events2 affected196 at risk
Lung abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Mucosal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Oral candidiasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Parotitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00033 events32 affected408 at risk EG00114 events14 affected202 at risk EG00213 events13 affected196 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Pyelonephritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Rash pustular	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected408 at risk EG0012 events2 affected202 at risk EG0023 events2 affected196 at risk
Respiratory tract infection bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected408 at risk EG0011 events1 affected202 at risk EG0024 events4 affected196 at risk
Septic shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0022 events2 affected196 at risk
Skin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Soft tissue infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Staphylococcal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Tracheobronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Wound infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Tracheal obstruction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Blood glucose increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Lipase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0022 events1 affected196 at risk
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
White blood cell count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0022 events2 affected196 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected408 at risk EG0017 events7 affected202 at risk EG0020 events0 affected196 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0022 events1 affected196 at risk
Ataxia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Cerebral infarction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Lethargy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0023 events3 affected196 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Mental status changes	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0023 events3 affected196 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0021 events1 affected196 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected408 at risk EG0013 events3 affected202 at risk EG0021 events1 affected196 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0011 events1 affected202 at risk EG0021 events1 affected196 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected408 at risk EG0011 events1 affected202 at risk EG0020 events0 affected196 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0021 events1 affected196 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected408 at risk EG0011 events1 affected202 at risk EG0024 events4 affected196 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0009 events7 affected408 at risk EG0012 events2 affected202 at risk EG0022 events1 affected196 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG0026 events5 affected196 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0011 events1 affected202 at risk EG0021 events1 affected196 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG0021 events1 affected196 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Haemorrhage	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk
Peripheral venous disease	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG0020 events0 affected196 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0010 events0 affected202 at risk EG0021 events1 affected196 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00068 events61 affected408 at risk EG00126 events22 affected202 at risk EG00297 events65 affected196 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0013 events2 affected202 at risk EG00248 events26 affected196 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0010 events0 affected202 at risk EG002103 events63 affected196 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG00024 events6 affected408 at risk EG0010 events0 affected202 at risk EG00276 events39 affected196 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG00030 events23 affected408 at risk EG0016 events6 affected202 at risk EG0020 events0 affected196 at risk
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG00079 events68 affected408 at risk EG00123 events21 affected202 at risk EG0027 events7 affected196 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00072 events59 affected408 at risk EG00125 events24 affected202 at risk EG00268 events54 affected196 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG000113 events70 affected408 at risk EG00120 events15 affected202 at risk EG00296 events60 affected196 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00028 events26 affected408 at risk EG0019 events8 affected202 at risk EG0024 events4 affected196 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00065 events52 affected408 at risk EG00114 events13 affected202 at risk EG002120 events74 affected196 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00016 events14 affected408 at risk EG0016 events6 affected202 at risk EG00254 events40 affected196 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00052 events34 affected408 at risk EG0019 events8 affected202 at risk EG00266 events39 affected196 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG00060 events52 affected408 at risk EG00123 events18 affected202 at risk EG00261 events38 affected196 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG00074 events66 affected408 at risk EG00141 events35 affected202 at risk EG00268 events56 affected196 at risk
Mucosal inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG00016 events15 affected408 at risk EG0018 events6 affected202 at risk EG00258 events43 affected196 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00054 events48 affected408 at risk EG00113 events12 affected202 at risk EG00233 events21 affected196 at risk
Paronychia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG00224 events21 affected196 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00022 events19 affected408 at risk EG0017 events7 affected202 at risk EG00212 events10 affected196 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00037 events27 affected408 at risk EG00110 events8 affected202 at risk EG00214 events11 affected196 at risk
Lipase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00027 events21 affected408 at risk EG0018 events5 affected202 at risk EG0022 events2 affected196 at risk
Neutrophil count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected408 at risk EG0011 events1 affected202 at risk EG00236 events24 affected196 at risk
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected408 at risk EG0011 events1 affected202 at risk EG00247 events22 affected196 at risk
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00042 events39 affected408 at risk EG00115 events13 affected202 at risk EG00232 events26 affected196 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00057 events52 affected408 at risk EG00122 events20 affected202 at risk EG00259 events46 affected196 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected408 at risk EG0010 events0 affected202 at risk EG00227 events16 affected196 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00011 events11 affected408 at risk EG0016 events3 affected202 at risk EG00277 events45 affected196 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00030 events26 affected408 at risk EG0014 events2 affected202 at risk EG00214 events11 affected196 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00027 events23 affected408 at risk EG0018 events8 affected202 at risk EG0025 events3 affected196 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected408 at risk EG0015 events5 affected202 at risk EG00210 events10 affected196 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00018 events15 affected408 at risk EG0017 events7 affected202 at risk EG00215 events14 affected196 at risk
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG00031 events29 affected408 at risk EG0019 events8 affected202 at risk EG00211 events11 affected196 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00047 events44 affected408 at risk EG00114 events14 affected202 at risk EG00215 events13 affected196 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00040 events34 affected408 at risk EG0015 events5 affected202 at risk EG00221 events18 affected196 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00022 events19 affected408 at risk EG00112 events12 affected202 at risk EG0025 events5 affected196 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected408 at risk EG0010 events0 affected202 at risk EG00211 events11 affected196 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected408 at risk EG0012 events2 affected202 at risk EG00250 events36 affected196 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00024 events23 affected408 at risk EG0014 events4 affected202 at risk EG00234 events26 affected196 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00061 events45 affected408 at risk EG00113 events11 affected202 at risk EG00218 events17 affected196 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG00062 events50 affected408 at risk EG00117 events17 affected202 at risk EG002114 events81 affected196 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected408 at risk EG0010 events0 affected202 at risk EG00223 events18 affected196 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00036 events27 affected408 at risk EG00110 events9 affected202 at risk EG00219 events11 affected196 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00015 events11 affected408 at risk EG0015 events5 affected202 at risk EG00216 events11 affected196 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00026 events23 affected408 at risk EG0016 events6 affected202 at risk EG00218 events14 affected196 at risk
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG00020 events15 affected408 at risk EG0014 events3 affected202 at risk EG00219 events12 affected196 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00010 events8 affected408 at risk EG0010 events0 affected202 at risk EG00211 events10 affected196 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00037 events29 affected408 at risk EG0018 events6 affected202 at risk EG00210 events8 affected196 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00026 events21 affected408 at risk EG0018 events6 affected202 at risk EG00242 events22 affected196 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00035 events29 affected408 at risk EG00112 events11 affected202 at risk EG00213 events13 affected196 at risk

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

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
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Title	Description
BG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
BG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression
BG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Durvalumab + Tremelimumab	tremelimumab (75 mg) via IV infusion every 4 weeks for a maximum of 4 doses, and durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression	356	413	168	408	317	408
EG001	Durvalumab	durvalumab (1500 mg) via IV infusion every 4 weeks until disease progression	176	204	78	202	153	202
EG002	Standard of Care (SOC)	either cisplatin (at a dose of 100 mg/m2 of body surface area as an IV infusion) or carboplatin (at an area under the concentration curve of 5 mg/mL/min as an IV infusion) on Day 1 of up to six 3-week cycles, and an infusion of 5-fluorouracil (5FU) (at a dose of 1000 mg/m2/day on Days 1 through 4) every 3 weeks, along with 400 mg/m2 of cetuximab on Cycle 1 Day 1 and 250 mg/m2 weekly for up to 6 cycles and maintenance cetuximab at 250 mg/m2 administered via IV infusion weekly thereafter in patients who achieved stable disease (SD) or better upon completion of chemotherapy until disease progression, toxicity, or withdrawal of consent	171	206	94	196	182	196

ID	Term
C000613593	durvalumab
C520704	tremelimumab
D000068818	Cetuximab
D005472	Fluorouracil
D002945	Cisplatin
D016190	Carboplatin